HDLC PRECIPITATING REAGENT

K982539 · Ac Biochemicals, Inc. · LBS · Sep 15, 1998 · Clinical Chemistry

Device Facts

• Record ID: K982539
• Device Name: HDLC PRECIPITATING REAGENT
• Applicant: Ac Biochemicals, Inc.
• Product Code: LBS · Clinical Chemistry
• Decision Date: Sep 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

The HDLC Precipitating Reagent is to be used in the separation of HDL from other serum lipoproteins to provide valuable information for the prediction of coronary heart disease when used in conjunction with total cholesterol and triglyceride determinations.

Device Story

The HDLC Precipitating Reagent is an in vitro diagnostic chemical reagent used in clinical laboratory settings. It functions by precipitating non-HDL lipoproteins (LDL and VLDL) from serum samples, allowing for the subsequent isolation and measurement of HDL cholesterol. The procedure is performed by laboratory technicians. The resulting HDL measurement is used by physicians to evaluate a patient's lipid profile and assess the risk of coronary heart disease. The device provides a diagnostic aid rather than a direct treatment, facilitating clinical decision-making regarding cardiovascular health management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Chemical precipitating reagent for in vitro diagnostic use. Operates via selective precipitation of non-HDL lipoproteins from serum. Standalone reagent kit. No software or electronic components.

Indications for Use

Indicated for the separation of HDL from other serum lipoproteins in serum samples to assist in the assessment of coronary heart disease risk when used alongside total cholesterol and triglyceride testing.

Regulatory Classification

Identification

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Predicate Devices

• K964917

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 5 1998

Charles C. Allain, Ph.D. . AC Biochemicals, Inc. 17955 Sky Park Circle, Suite J Irvine, California 92614

K982539 Re : HDLC Precipitating Reagent Requlatory Class: I Product Code: LBS Dated: July 14, 1998 Received: July 21, 1998

Dear Dr. Allain:

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 reqistration, 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 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 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) K964917:

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Device Name: HDLC Precipitating Reagent

Indications For Use:

The HDLC Precipitating Reagent is to be used in the separation of HDL from other serum lipoproteins to provide valuable information for the prediction of coronary heart disease when used in conjunction with total cholesterol and triglyceride determinations.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. 12 982539

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use Use<br>(Per 21 CFR 801.109) |
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Over-The-Counter