CHOL OR CHOLESTEROL

K971345 · Carolina Liquid Chemistries Corp. · CHH · May 29, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971345
• Device Name: CHOL OR CHOLESTEROL
• Applicant: Carolina Liquid Chemistries Corp.
• Product Code: CHH · Clinical Chemistry
• Decision Date: May 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1175
• Device Class: Class 1

Intended Use

Cholesterol Reagent is intended for the quantitative determination of serum total cholesterol using Beckman SYNCHRON CX Systems. The results are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood as well as disorders of lipid and lipoprotein metabolism.

Device Story

Cholesterol Reagent is an in vitro diagnostic chemical reagent used with Beckman SYNCHRON CX Systems. It facilitates the quantitative measurement of total cholesterol in serum samples. The device is intended for use in clinical laboratory settings by trained laboratory personnel. By providing accurate cholesterol concentration levels, the reagent assists clinicians in diagnosing and monitoring patients with lipid metabolism disorders and hypercholesterolemia. The output is a numerical concentration value, which healthcare providers use to assess patient cardiovascular risk and guide therapeutic interventions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic chemical reagent for use on automated clinical chemistry analyzers (Beckman SYNCHRON CX Systems). The device utilizes standard enzymatic colorimetric assay principles for cholesterol quantification. No specific materials, energy sources, or software algorithms are described in the provided documentation.

Indications for Use

Indicated for the quantitative determination of serum total cholesterol in patients to aid in the diagnosis and treatment of disorders involving excess blood cholesterol and lipid/lipoprotein metabolism disorders.

Regulatory Classification

Identification

A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## MAY 2 9 1997

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

Re: K971345 Cholesterol Reagent Requlatory Class: I Product Code: СНН April 8, 1997 Dated: 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, qood 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 (GMP) 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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All Property of the Property

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 regulation (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 Litman

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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Page_ 3 of 36

510(k) Number (if known): _

Device Name: Cholesterol Reagent

Indications For Use:

Cholesterol Reagent is intended for the quantitative determination of serum total cholesterol using CX Systems. Beckman SYNCHRON

used in the diagnosis and treatment The results are of disorders involving excess cholesterol in the lipid and lipoprotein metabolism blood as well as disorders.

(PLEASE DO NOT WAITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED!

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Number

(Division Sign-Off)
Division of Clinical Laboratory Devices
15971345

Prescription Use
(Per 21 CFR 801.109)

Over - The - Counter Use_

(Optional Format 1-2-96)

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OR