Carolina Liquid Chemistries

Next Generation HbA1c Test Available from Carolina Liquid Chemistries for Use on Beckman Synchron Chemistry Analyzers

2011-06-08T11:35:00.004-04:00

HbA1c is part of complete line of liquid, ready-to-use reagents offered by company

WINSTON-SALEM, N.C. (June 7, 2011) – Carolina Liquid Chemistries is proud to introduce Direct HbA1c in pre-filled cartridges for use on Beckman Synchron CX®, DX® and LX® chemistry analyzers. This assay has no interference from hemoglobin variants including HbC, HbS, HbE, and caramylated acetylated Hb or labile HbA1c.

Each Direct HbA1c kit includes two 90-test HbA1c cartridges and 30 mL of lyse. Also available are whole blood HbA1c controls. Unlike Synchron HbA1c synthetic controls, this preferred format ensures that dilution and lysing are done properly. Calibration is stable for 14 days. This direct HbA1c method correlates precisely with HPLC and is approved by NGSP.

Being a direct method means that HbA1c is determined directly and does not depend on a calculation using a hemoglobin and an A1c result. Avoiding the need for running two assays to get only one result means that Carolina Liquid Chemistries’ HbA1c finishes faster and frees up space on the reagent carousel, thus increasing on-board reagent capacity.

Other diabetic tests offered by Carolina Liquid Chemistries specific for Synchron analyzers include: Glucose, Fructosamine, GlycoMark (1,5 Anhydroglucitol), Insulin and MicroAlbumin.

Carolina Liquid Chemistries’ nationwide staff of service engineers allows the company to sell service contracts for Synchron CX®, DX® and LX® analyzers, offering significantly discounted service contract prices to reagent customers using its complete line of bar-coded, liquid, ready-to-use reagents. For more information about reagents or service for Beckman Synchron chemistry analyzers, call (877) 722-8910 or send an e-mail to contactsales@carolinachemistries.com.

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Carolina Liquid Chemistries Featured on "Inside CSUF"

2010-09-15T11:56:00.011-04:00

Education to Meet Industry Needs

Biotech Program Benefits Students, Employers

By Russ L. Hudson

(Carolina Liquid Chemistries was recently featured on "Inside CSUF" at California State University, Fullerton.)

Before Cal State Fullerton student Ron Morley finished his first year of the new two-year professional science master’s degree program with a focus on biotechnology, he’d already benefited. He got a new job.

Morley served a summer internship with biotech company Carolina Liquid Chemistries in Brea. Carolina produces chemicals and reagents for hospitals, laboratories and physicians. It was his education in the Program for Applied Biotechnology Studies at Cal State Fullerton that got him the permanent position.

It’s a big change from the flooring company he ran since earning a bachelor’s in biology in 2004. ”At Carolina, I've been working on quality assurance and regulatory assurance. Those are the master files and paper trails for everything we do,” said Morley. “Because I had already acquired basic knowledge and skills through PABS, Carolina's processes were already familiar.”

“Ron ‘got it’ the first day,” said Jim Henneman, Carolina’s director of regulatory and quality assurance, an alumnus (B.A. biological sciences ’79) and member of a PABS planning committee. “The previous graduates we hired were knowledgeable in specific fields but knew little about international aspects, regulations or the business end. It took time to train them, making it an expensive process and slowing production.

“Graduates like Ron who arrive already trained can give us a competitive edge,” he said.

Cal State Fullerton, joined by Cal State Los Angeles, Cal Poly Pomona and industry leaders, designed the program specifically to supply the kind of graduates the biotech industry needed. The area from Los Angeles to San Diego has the country’s highest concentration of biotech companies, but graduates lacked a wide knowledge base, said biotech industry veteran Dave Dyer, who serves as PABS director.

The three-campus PABS consortium is part of a California State University systemwide effort to offer updated, industry-sensitive professional science master’s degrees, and its focus meshes with a Cal State Fullerton campuswide initiative on science, technology, engineering and math.

The effort is fueled by funding of nearly $1.5 million from the Alfred P. Sloan Foundation and $100,000 from Abbott Laboratories. The program was called the most advanced in the nation when it was presented at the National Governor’s Association Professional Science Master’s Academy in 2008.

Donald Hodgson, president of Controlled Nanovolumes in Fullerton, said his intern, too, had an immediate impact. “Philip Ngo’s primary job was working with others on product development of drug delivery systems. He came prepared with advanced knowledge, and his contributions were invaluable.” Controlled Nanovolumes provides commercial applications of technology for nutrition, chemistry and medicine.

Ngo, a Buena Park resident and associate scientist at Gilead Sciences Inc., a biopharmaceutical company that focuses on viral and infections diseases and cancer, credited PABS for his transformation from a biochemist who knew only that field to the leader he was at Nanovolumes.

“I like that PABS makes us work in teams. We have to exercise good communications, leadership and problem-solving while taking into account other team members’ personalities and skills,” he said. “I’ve found I am capable of more than I thought.”

Gerard Jensen, Gilead’s director of development and technical service, has a dual perspective on PABS: as a member of the biotech industry and as a part-time PABS instructor at Cal State Fullerton. As a professional, Jensen sees many in biotech awakening to the need for expanded expertise and looking for places to get it, and as an instructor what impresses him is “the brightness of the students. They’re eager to grasp and use new concepts. It shows at work.”

Courses progress from the introductory, such as commercialization of biotechnology and bioinformatics, and advance to molecular biology, pharmacology, biomedical devices and regulatory and quality assurance. Year two moves on to advanced courses in those subjects plus choices in specific fields of interest, such as biochemistry, biomathematics, biotech engineering and analytical engineering.

This year, the program’s first cohort of 12 students will start their capstone project. Each student or student team’s project will be a real-life, real-time industrial challenge provided by participating biotech companies. Each company will assess the students’ work.

Among the participating biotech firms are Gilead, Carolina, Allergan Inc., Watson Laboratories Inc., Molecular Express, Irvine Pharmaceutical Services, Grifols USA and Advanced Bionics. In all, nearly four dozen Southern California biotech companies support PABS. Company leaders provide guidance on the curriculum and will speak to students, while many also provide internships, case studies and instructors.

This year’s 20-student cohort, which recently finished a one-month, high-intensity Survey of Biotechnology course, will have more educational opportunities than the pioneer group, Dyer said. As the program grows, PABS is forming online courses and a biomaterials engineering concentration.

In addition, Sahar Shaheim of Cal State L.A., a second-cohort member, has formed a PABS Biotechnology Club that will organize lectures by biotech and pharmaceutical leaders, and the California State University system, in collaboration with the health sciences industry, has formed Biocompass. Biocompass is a clearinghouse for educational opportunities and is developing two certificate programs in Biotechnology Project Management.

“PABS is about teamwork between industry, academia and students and our shakeout year has gone well,” said Dyer. “There is constant assessment of industrial training and education needs, so the new opportunities don’t end here.”

Physicians Can Now Test for Heroin with 6-AM on the BioLis 24i Chemistry Analyzer

2010-08-23T17:20:00.012-04:00

6-Acetylmorphine assay is specific to heroin use, aids in eliminating cross-reactivity with codeine, morphine and other drugs

WINSTON-SALEM, N.C. (August 23, 2010) — Physicians can now test specifically for heroin use in their offices using the benchtop BioLis 24i chemistry analyzer. Carolina Liquid Chemistries, the provider of the BioLis 24i chemistry system, has added 6-Acetylmorphine, also known as 6-AM, to its expansive menu for the BioLis.

The BioLis 24i is one of the fastest growing physician office analyzers on the market, offering more than 16 drugs of abuse tests and more than 80 different tests overall. 6-AM is a unique metabolite of heroin (3,6 diacetylmorphine) and cannot be synthesized in the body from other opioids, such as codeine or morphine. The presence of 6-AM in the urine confirms that heroin was the opioid used by the patient.

“The specificity of the 6-AM assay is significant,” says Phil Shugart, President of Carolina Liquid Chemistries. “Other immunoassays for heroin test for the presence of morphine, which is a metabolite of a number of different illegal opiates. By providing a more specific assay for a certain drug of abuse, physicians can perform testing and make decisions about treatment plans more quickly and economically.”

Carolina Chemistries offers physicians a complete laboratory system consisting of equipment, assistance with CLIA compliance, technologist training offered in a state-of-the-art technology center and EMR interface capabilities.

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About Carolina Liquid Chemistries Corp.

Founded in 1997 in Brea, Calif., Carolina Liquid Chemistries is an FDA regulated, ISO certified medical device manufacturer, distributor and service provider of chemistry systems and reagents for hospitals, clinical reference laboratories and physician practices. Now headquartered in the Piedmont Triad Research Park of Winston-Salem, N.C., Carolina Chemistries offers chemistry instruments that range in throughput from 180 to 1,400 tests per hour and repackages homocysteine reagents for a variety of chemistry analyzers in the bar-coded packages for Beckman and Olympus instruments. For more information, visit http://www.carolinachemistries.com.

Physicians Now Have the Ability to Test for Buprenorphine in Their Offices Using the BioLis 24i Chemistry Analyzer

2010-08-12T10:44:00.003-04:00

Assay detects buprenorphine and its primary metabolite, norbuprenorphine,
without opiate cross-reactivity.

WINSTON-SALEM, N.C. (August 12, 2010) – Carolina Liquid Chemistries, the provider of the BioLis 24i chemistry system, one of the fastest growing physician office chemistry analyzers on the market offering more than 80 different tests and 16 drugs of abuse tests, has added buprenorphine to its expansive menu.

Physicians are now able to perform testing on patients quickly and economically in order to monitor the potential for abuse of the schedule III opiod. Buprenorphine is intended for the treatment of pain under the trade name Buprenex® and for the treatment of narcotic addiction under the trade names Suboxone® and Subutex®.

“We have added buprenorphine to a test menu that includes 6-AM, oxycodone, cocaine, methadone, THC, opiates, phencyclidine, benzodiazepine, amphetamine, PCP, propoxyphene, barbiturates, alcohol, salicylates and acetaminophen,” said Phil Shugart, president of Carolina Chemistries. “Physicians can obtain both a qualitative screen or a specific quantitative result using the BioLis 24i — giving them the benefit of same-day results on the patient’s drug levels. This allows them to provide immediate feedback to the patient and make treatment decisions and medication adjustments before the patient leaves the office.”

Carolina Liquid Chemistries offers the complete laboratory system, consisting of equipment, assistance with CLIA compliance, technologist training offered in a “state of the art” technology center and EMR interface capabilities.

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About Carolina Liquid Chemistries Corp.
Founded in 1997 in Brea, Calif., Carolina Liquid Chemistries is an FDA regulated, ISO certified medical device manufacturer, distributor and service provider of chemistry systems and reagents for hospitals, clinical reference laboratories and physician practices. Now headquartered in the Piedmont Triad Research Park of Winston-Salem, N.C., Carolina Chemistries offers chemistry instruments that range in throughput from 180 to 1,400 tests per hour and repackages homocysteine reagents for a variety of chemistry analyzers in the bar-coded packages for Beckman and Olympus instruments. For more information, visit http://www.carolinachemistries.com.

Carolina Liquid Chemistries Expands Menu of Reagents to Better Meet the Needs of Labs Using Beckman Synchron® Chemistry Analyzers

2010-07-19T12:06:00.006-04:00

Company’s technology provides improved turnaround time, less processing time and improved accuracy.

WINSTON-SALEM, N.C. (July 19, 2010) – Carolina Liquid Chemistries Corp. has expanded it menu of reagents for the Beckman Synchron chemistry analyzers — offering a wider selection of reagents that are not available through the instrument’s manufacturer.

Some of the reagents that have not been available through the manufacturer can now be purchased through Carolina Chemistries, including Lp(a), Albumin (BCG), Cystatin C, D dimer, fructosamine, 1.5 AG, lithium and wide-range CRP. “In today’s environment, we want to assist laboratories in the most efficient and effective use of their instruments,” said Phil Shugart, president of Carolina Chemistries. “Diluting samples due to reagents having lower linear limits takes time and slows down equipment that is meant to be fast. When laboratories have the ability to run more tests on their existing instruments, they are maximizing the instrument’s use for cost effectiveness.

In addition to offering a wide range of reagents, Carolina Chemistries had implemented technology to improve laboratory speed, efficiency and accuracy. Examples of the advantages of Carolina reagents are:

HbA1c only requires one cartridge, which reduces the amount of lab tech processing time and speeds up the results.
Homocysteine reagents do not have iron interference, which can cause inaccurate results.
Magnesium has 30-day on-board stability.
Sample dilution is not required for Carolina Chemistries specific proteins: transferrin, haptoglobin, C3, C4, APO A1 and APO B.
Sample preparation — manually transferring reagent from compartment “C” to “A” — has been eliminated for Carolina Chemistries AST, ALT, CK and TG. This saves time and removes an opportunity for lab error.
The time to first result for Carolina Chemistries LDL and HDL is approximately twice as fast — nine minutes compared to 16 and 18 with other reagents.

“Carolina Liquid Chemistries continues to put the science back into the laboratory,” Shugart said. “We are continually improving the process with better, faster, more efficient options.”

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About Carolina Liquid Chemistries Corp.
Founded in 1997 in Brea, Calif., Carolina Liquid Chemistries is a manufacturer, distributor and service provider of chemistry systems and reagents for hospitals, clinical reference laboratories and physician practices. Now headquartered in the Piedmont Triad Research Park of Winston-Salem, N.C., Carolina Chemistries offers chemistry instruments that range in throughput from 180 to 1,400 tests per hour and repackages homocysteine reagents for a variety of chemistry analyzers in the bar-coded packages for Beckman and Olympus instruments. For more information, visit http://www.carolinachemistries.com.

2010 AACC Clinical Lab Expo

2010-07-06T15:23:00.004-04:00

Discover how your lab or clinic can reap the benefits of speedy, efficient and economical chemistry analyzers with better quality control. Carolina Liquid Chemistries will be demonstrating the BioLis 24i and the MPAM during the AACC Clinical Lab Expo. Visit us in Booth #7611, July 27-29, at the Anaheim Convention Center.

Carolina Liquid Chemistries Offers Complete Drug Testing Solution for Pain Clinics

2010-05-14T07:19:00.005-04:00

The Preferred Pain Program ensures proper lab procedures and implementation, along with same-day results on the BioLis 24i chemistry analyzer.

WINSTON-SALEM, N.C. (May 11, 2010) – Pain medicine clinics who want to provide better patient care by having a laboratory on-site, but have concerns over adhering to proper laboratory compliance and coding, now have a quality solution with the Preferred Pain Program announced by Carolina Liquid Chemistries (http://www.carolinachemistries.com) Corp.

“The Preferred Pain Program is a complete laboratory package that has been designed to provide the highest quality patient care in addition to helping pain management clinics successfully navigate CLIA (Clinical Laboratory Improvement Amendment of 1988) and the new billing environment,” said Phil Shugart, president of Carolina Chemistries. “It is a straightforward solution to proper lab procedures and implementation with expert assistance in bringing drug testing in-house with the BioLis 24i bench top chemistry analyzer.”

The program provides a CLIA specialist to help ensure compliance. “We have signed an agreement with compliance specialists at DoctorsManagement,” Shugart explained. “Our clients are provided with technical consulting, including application assistance; assistance with proper manuals, education, and quality reports; and telephone assistance.”

With the Preferred Pain Program, pain clinics reap the benefits of the economical and efficient BioLis 24i chemistry analyzer, which runs a qualitative and a quantitative analysis in-house — not just the qualitative analysis provided with urine dipstick tests and other bench top chemistry analyzers. “The BioLis provides a single qualitative and quantitative reimbursable result per drug of abuse,” said Shugart. “With same-day results, physicians can make treatment decisions much more quickly; provide better quality control with lower risk of error and tampering; and have better lab procedures and practice economics.” The BioLis 24i can also perform liver function and kidney function tests, in addition to more than 80 other chemistry tests.

The BioLis test menu includes acetaminophen, alcohol, amphetamine, barbiturates, benzodiazepine, buprenorphen cocaine, ecstasy, methadone, opiates, oxycodone, PCP, phencyclidine, propoxyphene, salicylates and THC. The instrument performs over 400 tests per hour and uses permanent reaction cuvettes, eliminating the need for expensive disposable cuvettes that are considered hazardous waste. The BioLis 24i is compatible with most LIS systems, eliminating the need for paper documents, and utilizes an H₂O system, eliminating the cost and the need for space to store water cubes.

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About Carolina Liquid Chemistries Corp.

Founded in 1997 in Brea, Calif., Carolina Liquid Chemistries is a manufacturer, distributor and service provider of chemistry systems and reagents for hospitals, clinical reference laboratories and physician practices. Now headquartered in the Piedmont Triad Research Park of Winston-Salem, N.C., Carolina Chemistries offers chemistry instruments that range in throughput from 180 to 1,400 tests per hour and repackages homocysteine reagents for a variety of chemistry analyzers in the bar-coded packages for Beckman and Olympus instruments. For more information, visit http://www.carolinachemistries.com.

Fast Chemistries Increase Speed and Efficiency in the Laboratory

2010-03-23T11:05:00.004-04:00

Carolina Liquid Chemistries puts the science back into chemistries with development of some
of the most robust reagents available.

WINSTON-SALEM, N.C. (March 23, 2010) – Using the most advanced formulations and the finest raw materials, Carolina Liquid Chemistries has developed a complete line of fast chemistries for the Beckman Synchron CX®, DX® and LX® chemistry analyzers. This menu of 100 ready-to-use reagents in bar-coded cartridges have greater linearity, faster reactions and longer stabilities that save time and optimize results for reference and hospital labs.

The greater linearity allows labs to turn off Over Range Detection and Correction (ORDAC).
“Through years of intense research and development, we have created reagents that have wider linear limits,” said Phil Shugart, president of Carolina Chemistries. “For example, our amylase may go up to 2,400 IUs whereas another company’s reagent only goes up to 240 IUs. This matters because when a test goes over 240 IUs, the instrument has to ORDAC, which delays getting results back to the doctor.”

By eliminating ORDAC and sample dilutions — which take a complete cycle, just like running an assay — sample tubes come off faster, resulting in faster reported results. In addition, Carolina Chemistries has eliminated reagent preparation — the transfer of “C” to “A” — which also saves time and removes an opportunity for lab error.

The time saved per test is significant. For example, Carolina Chemistries’ lipid panels, specifically HDL and LDL, provide labs with a time to first result that is twice as fast as some other reagents — 10 minutes instead of 20 minutes.

“Continuous process improvement standards and improved patient care are key aspects of improving health care quality,” Shugart said. “When a lab can speed up hundreds of results by 10 minutes, that equates to thousands of minutes of time saved with faster results for doctors and patients— time that can be crucial in diagnosing patients.”

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Carolina Liquid Chemistries Offers GlycoMark® Test for Diabetes Management for Use on General Chemistry Analyzers

2010-03-03T18:37:00.001-05:00

1.5AG blood test can be run on Beckman, Olympus, Siemens Advia and other instruments.

WINSTON-SALEM, N.C. (March 3, 2010) – Carolina Liquid Chemistries Corp. has partnered with GlycoMark Inc. to market the GlycoMark® blood test as one of a complete range of diabetes assays for use on general chemistry analyzers. GlycoMark® tests for 1.5 -anhydro-D-glucitol- (1.5AG).

Carolina Liquid Chemistries, a manufacturer, distributor and service provider for reagents and chemistry systems, teamed up with GlycoMark Inc., the test manufacturer, to market the GlycoMark® blood test for use on Biolis 24i, Beckman, Olympus and Siemens Advia chemistry analyzers. In most cases, Carolina Chemistries applications achieve more tests per kit.

“There are 1.6 million people diagnosed with diabetes each year,” said Phil Shugart, president of Carolina Liquid Chemistries. “Through this partnership, we will promote a system for helping health care providers manage this epidemic with a complete menu of diabetic assays: HbA1c, glucose, fructosamine, insulin, kidney function tests and now GlycoMark®, one of the most important tests for better management of diabetes and prevention of the devastating diseases that accompany it.”

GlycoMark® tests for postprandial hyperglycemia — the high blood glucose spikes a person experiences soon after eating. Monitoring and controlling these spikes are key aspects of proper diabetes management, and GlycoMark® is an FDA approved, reimbursed, non-fasting blood test that monitors intermediate glycemic control and can be administered monthly.

“Because HbA1c only identifies a person’s average glucose level over time, it misses up to 40 percent of patients in near normal ranges (6.0 to 8.5 percent) who are not in good glycemic control, ” said Eric Button, president of GlycoMark Inc. “This can lead to cardiovascular disease, retinopathy and other complications of diabetes. GlycoMark® identifies peak glucose levels after a person eats, so physicians can identify those patients and prescribe the proper medications.”

Carolina Liquid Chemistries offers a complete line of bar coded reagents for use on BioLis 24i, Beckman, Olympus and Siemans Advia chemistry analyzers. Using the most advanced formulations and finest raw materials, Carolina Chemistries is able to offer clinical laboratories robust chemistries — greater linearity, faster reactions and longer stabilities.

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Carolina Liquid Chemistries Offers GlycoMark(R)... | MyPRGenie

2010-03-03T16:50:00.000-05:00

Carolina Liquid Chemistries Offers GlycoMark® for General Chemistry Analyzers... | MyPRGenie

Carolina Liquid Chemistries Partners with GlycoMark Inc. on New Generation Test for Diabetes Management

2010-02-25T13:06:00.001-05:00

GlycoMark® test for postprandial hyperglycemia can now be run in the physician’s office on the BioLis 24i bench top chemistry analyzer.

WINSTON-SALEM, N.C. (Feb. 25, 2010) – North Carolina’s Piedmont Triad Research Park was the catalyst for a partnership to provide doctors with a postprandial hyperglycemia blood test that can be analyzed in the physician’s office. Carolina Liquid Chemistries Corp. will market the GlycoMark® blood test as one of a complete range of diabetes assays for the BioLis 24i bench top chemistry analyzer.

Carolina Liquid Chemistries, a manufacturer, distributor and service provider for reagents and chemistry systems, teamed up with GlycoMark Inc., the test manufacturer, to market a complete system for diabetes associated diagnostic tests. “There are 1.6 million people diagnosed with diabetes each year,” said Phil Shugart, president of Carolina Liquid Chemistries. “Through this partnership, we will promote a system for helping physicians manage this epidemic. The Biolis 24i is the only physician office instrument that offers a complete menu of the diabetic assays: HbA1c, glucose, fructosamine, insulin, kidney function tests and now GlycoMark®, one of the most important tests for better management of diabetes and prevention of the devastating diseases that accompany it.”

Monitoring and controlling postprandial hyperglycemia — the high blood glucose spikes a person experiences soon after eating — are key aspects of proper diabetes management. GlycoMark® is an FDA approved, reimbursed, non-fasting blood test that monitors intermediate glycemic control and can be administered monthly. “Because HbA1c only identifies a person’s average glucose level over time, it misses up to 40 percent of patients in near normal ranges (6.0 to 8.5 percent) who are not in good glycemic control, ” said Eric Button, president of GlycoMark Inc. “This can lead to cardiovascular disease, retinopathy and other complications of diabetes. GlycoMark® identifies peak glucose levels after a person eats, so physicians can identify those patients and prescribe the proper medications.”

Until now, GlycoMark® was only available through reference labs, so physicians had to wait for results before prescribing treatment. Now, with the BioLis 24i, the physician’s office can perform the test on site and have the results within minutes. “The physician has same day results, can provide immediate feedback to the patient, and make treatment decisions and medication adjustments before the patient leaves the office,” Shugart said.

There are more than 3,000 BioLis 24i chemistry analyzers in use worldwide. The BioLis 24i performs over 400 tests per hour, uses permanent reaction cuvettes instead of disposable and a water system instead of water cubes. It is also compatible with all LIS systems, which eliminates the need for paper documents.

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510k Information

2010-02-23T19:42:00.004-05:00

CAROLINA LIQUID CHEMISTRIES
TECHNICAL BULLETIN
FEBRUARY 2010

This bulletin is meant to provide you with documentation to confirm the 510 clearance of
the Tokyo Boeki Medical System, LTD. In Akiruno, Japan, BioLis 24i.

Carolina Liquid Chemistries, the exclusive, U.S. supplier of Tokyo Boeki Medical
System benchtop chemistry, has been informed that the BioLis 24i has been cleared for
marketing via US FDA 510k number K040958 on February 15, 2005 under the names of
Prestige 24i, Prestige 400, and MGC 240. Tokyo Boeki’s 510k submission annotates
these as the Proprietary and Established names of the analyzer. Further annotation states
that “These are the same models except the names.”

The US FDA Web site link to verify this information is:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=14915

To answer the questions “Why isn’t the Biolis 24i recorded in the US FDA 510k
clearances?” please refer to the US FDA Establishment Registration Device Listing
database for Tokyo Boeki.

Tokyo Boeki lists the following Clinical Chemistry Analyzers on the US FDA
Establishment Registration Device Listing Web page. Please note that these are the same
analyzers under different names as cleared under the 510k number K040958. In
summary, the BioLis 24i is the same instrument as all others listed below, simply another
name.

BIOLIS 24I MGC 240 SIRRUS Biolis 24i
Premium Biolis
24iPremium
Series

Diag Premium LABMAX 240
Premium MGC 240
Premium Prestige 24I Prestige 24i
Premium

SAPPHIRE 400
Premium SIRRUS
Premium SPA Premium TMS-1024i
Premium TRX-7010

The US FDA Web site link to verify this information is:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

You will have to the type in Tokyo Boeki in the Establishment Name box. Please note
that to have a device listing on the US FDA Establishment Registration Device Listing
database the firm must have a cleared 510k number; in this case 510k number K040958.

The Biolis (Prestige 24i) 510k clearance was for Ion Specific Electrolytes (ISE)
Potassium, Chloride, and Sodium. Additional chemistries were submitted to the US FDA
510k Premarket Approval Process by Stanbio Laboratory of Boerne, Texas, US FDA
Registration number 1616487. Stanbio submitted these additional chemistries under the
requirements of Clinical Laboratory Improvement Amendments (CLIA) with Analyte
Specialty and Complexity identifiers as General Chemistry and Moderate respectively.

The US FDA Web site link to verify this information is:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/Search.cfm

You will have to type in Stanbio in the Test System/Manufacture box.

To summarize this information, the conclusion is that the Carolina Liquid Chemistries
Biolis 24i, along with the ISEs and chemistry reagents are cleared by the FDA.

James M. Henneman
Director Regulatory Affairs and Quality Assurance

Today's Triad Business Journal

2010-02-19T17:17:00.003-05:00

Carolina Liquid Chemistries was featured in today's Business Journal article: "Distribution contracts lead to job growth for tech firm."

Article link: triad.bizjournals.com/triad/stories/2010/02/22/story5.html

The 2010 Quality Campaign

2010-02-18T17:33:00.005-05:00

Carolina Liquid Chemistries wants to continue to provide the best customer service for your laboratory well into the future. To ensure the highest level of service, we have initiated a 2010 Quality Campaign.

A key aspect of our continuous quality improvement is Technical and Service Support. Whenever you have a question, concern or service issue, please call:

Technical Support (800) 471-7272

By calling Technical Support first, it allows us to track your service issue and get it resolved quickly and efficiently. This allows us to recognize trends that may be occurring among users. Please do not call the cell phones of technical representatives or sales representatives, because this will greatly impede the process of reporting and resolving your technical issue.

Good luck in 2010 and thank you again for your continued business.

Carolina Liquid Industries Expands Beckman Synchron CX® and LX® Chemistry Analyzer Service and Support

2010-02-13T18:45:00.011-05:00

Company helps extend the life of older Beckman Synchron chemistry analyzers.

WINSTON-SALEM, N.C. (Feb. 2, 2010) – In an economic era that emphasizes extending resources, Carolina Liquid Industries Corp. has expanded their service organization with engineers who have been factory trained to service and support all Beckman Synchron CX® chemistry analyzers — both the newer models and the older models that may no longer be under service agreements. Service contracts are available and run approximately 40 percent less than those of the OEM (original equipment manufacturer).

“In today’s health care environment, physician offices, laboratories and hospitals are looking for increased value and solutions for reducing cost,” said Phil Shugart, president of Carolina Liquid Chemistries. “We are helping our customers continue the same level of performance with their older chemistry analyzers by providing high-quality service at a less expensive rate. There are a plethora of older Synchrons on the market that are extremely reliable and valuable in the marketplace and provide excellent results.”

Carolina Liquid Chemistries provides a personalized approach to service and support for all models of the Beckman Synchron CX3, CX4, CX5, CX7, CX9 and LX20s. Customers speak directly to a technical representative rather than going through a series of prompts and entering a serial number or user ID.

“Busy labs want to speak to a live person and get their service issue resolved quickly,” Shugart said. “Our engineers provide on-site repair, maintenance and troubleshooting, and our medical technologists provide on-site assistance with validation studies, setting up new assays, training and retraining.”

Carolina Liquid Chemistries offers a complete line of bar-coded, liquid, ready-to-use reagents that correlate 1:1 with OEM reagents, including esoteric assays such as homocysteine, Lp(a), fructosamine and GlycoMark. Customers who use the company’s reagents may qualify for a no-charge service contract. For more information about reagents or service on an older model Beckman CX® chemistry analyzer, call (877) 722-8910 or send an e-mail to contactsales@carolinachemistries.com.

BioLis 24i Available for Pain Medication Monitoring

2010-02-13T18:26:00.006-05:00

Bench Top Chemistry Analyzer Provides Immediate Results, Better Economics for Pain Clinics

WINSTON-SALEM, N.C. (Jan. 25, 2010) – Pain management clinics that must monitor patients’ use and potential abuse of prescription drugs can now perform drug testing within their own facilities with the Carolina BioLis 24i, a bench top chemistry analyzer offered by Carolina Liquid Chemistries Corp.

Carolina Liquid Chemistries, a manufacturer, distributor and service provider for reagents and chemistry systems, is offering the BioLis 24i as a simple solution for pain management clinics in need of a vehicle to perform drug testing in their own facilities.

“Pain management clinics are searching for fast, economical alternatives to monitoring potential abuse of prescription medications,” said Phil Shugart, president of Carolina Liquid Chemistries. “With our bench top chemistry analyzer, they can now set up laboratories within the pain management facility and obtain both a qualitative screen and quantitative results. The physician has benefit of same-day results on the patient’s drug levels, can provide immediate feedback to the patient, and can make treatment decisions and medication adjustments before the patient leaves the office — rather than waiting on test results from an outside lab.”

In addition to faster results, a clinic’s in-house laboratory analysis of prescription pain medication usage provides better quality control with lower risk of lab error or tampering. The test menu includes oxycodone, cocaine, methadone, THC, opiates, phencyclidine, benzodiazepine, amphetamine, PCP, propoxyphene, barbiturates, alcohol, salicylates and acetaminophen.

There are more than 3,000 BioLis 24i chemistry analyzers in use worldwide. The BioLis 24 performs over 400 tests per hour, and the system uses permanent reaction cuvettes, eliminating the need for expensive disposable cuvettes that have to be disposed of as hazardous waste. In addition, it utilizes a water system that eliminates the cost and the need for additional space to store water cubes. The BioLis 24i is compatible with all LIS systems, which eliminates the need for paper documents. “By offering the BioLis 24i bench top chemistry analyzer as an option for drugs of abuse monitoring, we are offering pain management clinics an easy to use solution that provides better patient care and makes economic sense for the practice,” Shugart said.

Eco-Friendly Analyzer

2009-04-15T08:50:00.003-04:00

Carolina Liquid Chemistries has gone ECO-FRIENDLY and ECONOMICAL with their new BioLis 24i chemistry analyzer. This analyzer uses permanent cuvettes, eliminating the need for expensive disposable cuvettes that have to be disposed of as hazardous waste. The BioLis 24i does not require water cubes. This analyzer can use a water system that eliminates the need for additional space to store water cubes and the additional costs associated with their cubes. The BioLis 24i is compatible to all LIS systems, thus eliminating the need for paper documents.