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.

-End-

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

Today's Triad Business Journal

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

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

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

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.