CHOLESTEROL RAPID LIQUID REAGENT

K972853 · Reagents Applications, Inc. · CHH · Sep 24, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972853
• Device Name: CHOLESTEROL RAPID LIQUID REAGENT
• Applicant: Reagents Applications, Inc.
• Product Code: CHH · Clinical Chemistry
• Decision Date: Sep 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1175
• Device Class: Class 1

Intended Use

This reagent is intended for the rapid quantitative in-vitro measurement of total serum or plasma cholesterol concentration, utilizing manual or automated analyzers. The determination of serum plasma is one of the important tools in the diagnosis and classification of lipemia. Other conditions, such as hepatic and thyroid diseases, influence cholesterol levels.

Device Story

RAICHEM Cholesterol Rapid Liquid Reagent is an in-vitro diagnostic reagent for quantitative measurement of total cholesterol in serum or plasma. Used in clinical laboratory settings; operated by laboratory technicians or clinicians. Reagent added to patient samples (serum/plasma) in manual or automated analyzers; chemical reaction produces measurable signal proportional to cholesterol concentration. Output provides quantitative cholesterol level; assists healthcare providers in diagnosing/classifying lipemia and evaluating hepatic or thyroid disease status. Benefits patient by providing rapid diagnostic data for lipid metabolism assessment.

Clinical Evidence

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

Technological Characteristics

Liquid reagent for quantitative in-vitro cholesterol measurement. Compatible with manual or automated clinical chemistry analyzers. Class I device.

Indications for Use

Indicated for the quantitative in-vitro measurement of total serum or plasma cholesterol concentration in patients to aid in the diagnosis and classification of lipemia and assessment of conditions such as hepatic and thyroid diseases.

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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SEP 2 4 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Daniel C. Weyker Vice President RAICHEM Division of Hemagen Diagnostics 8225 Mercury Count San Diego, California 92111-1203

Re: K972853 Trade Name: RAICHEM Cholesterol Rapid Liquid Reagent Regulatory Class: I Product Code: CHH Dated: September 17, 1997 September 24, 1997 Received:

Dear Mr. Weyker:

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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 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 (CDIA-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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

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: K972853

## Device Name: Cholestero! Rapid |Liquid Reagent

Indications for Use:

This reagent is intended for the rapid quantitative in-vitro measurement of total serum or plasma cholesterol concentration, utilizing manual or automated analyzers. The determination of serum plasma is one of the important tools in the diagnosis and classification of lipemia. Other conditions, such as hepatic and thyroid diseases, influence cholesterol levels.

V. Lucille Chamber, Ph.D.

prescription us

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