TRIGLYCERIDES, TG, OR TRIG

K971324 · Carolina Liquid Chemistries Corp. · CDT · Jun 20, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971324
• Device Name: TRIGLYCERIDES, TG, OR TRIG
• Applicant: Carolina Liquid Chemistries Corp.
• Product Code: CDT · Clinical Chemistry
• Decision Date: Jun 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1705
• Device Class: Class 1

Intended Use

The Triglycerides Reagent is intended for the quantitative determination of serum triglycerides using the Beckman SYNCHRON CX Clinical System:s. Elevated serum triglyceride levels are associated with increased risk of coronary artery disease, pancreatitis, and numerous genetic lipoprotein disorders.

Device Story

Triglycerides Reagent is an in vitro diagnostic reagent used for quantitative measurement of serum triglycerides. It is designed for use on the Beckman SYNCHRON CX Clinical Systems. The reagent facilitates the biochemical analysis of serum samples to determine triglyceride concentrations. Results are used by clinicians to evaluate patient risk for coronary artery disease, pancreatitis, and various genetic lipoprotein disorders. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

No clinical data provided; device is an in vitro diagnostic reagent.

Technological Characteristics

In vitro diagnostic reagent for quantitative biochemical analysis of serum triglycerides. Designed for use on Beckman SYNCHRON CX Clinical Systems. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for the quantitative determination of serum triglycerides in patients to assess risk of coronary artery disease, pancreatitis, and genetic lipoprotein disorders.

Regulatory Classification

Identification

A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## JUN 20 1997

Cynthia Shugart President Carolina Liquid Chemistries Corporation 451 West Lambert Road, Suite 207 Brea, California 92821

Re: K971324 Triglycerides, TG, or TRIG Reagent Regulatory Class: I Product Code: CDT Dated: April 8, 1997 Received: April 10, 1997

Dear Ms. Shugart:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (CMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as "-" described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

* If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):___

Device Name:_Triglycerides Reagent

Indications For Use:

The Triglycerides Reagent is intended for the quantitative determination of serum triglycerides using the Beckman SYNCHRON CX Clinical System:s.

Elevated serum triglyceride levels are associated with increased risk of coronary artery disease, pancreatitis, and numerous genetic lipoprotein disorders.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K971324 |

Prescription Use
OR
Over-The-Counter Use

(Per 21 CFR 801.109)
(Optional Format 1-2-96)

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