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

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

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.

Fast Chemistries Increase Speed and Efficiency in the Laboratory

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

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

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

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

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

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