RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER

K023784 · Hemagen Diagnostics, Inc. · LBR · Dec 24, 2002 · Clinical Chemistry

Device Facts

• Record ID: K023784
• Device Name: RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER
• Applicant: Hemagen Diagnostics, Inc.
• Product Code: LBR · Clinical Chemistry
• Decision Date: Dec 24, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

Raichem Cholesterol Rapid Liquid Reagent may be used with the CANTROL® HDL Cholesterol Precipitating Reagent Tubes to separate and determine HDL cholesterol in serum or EDTA plasma on the Cobas Mira chemistry systems. High-density lipoprotein measurement in conjunction with other lipid determinations has been shown to be useful in assessing the risk of coronary artery disease. For In Vitro Diagnostic Use Only.

Device Story

Device consists of Raichem Cholesterol Rapid Liquid Reagent and CANTROL HDL Cholesterol Precipitating Reagent Tubes; used on Cobas Mira chemistry analyzers. Precipitating tubes separate HDL cholesterol from other lipoproteins in serum or EDTA plasma samples. Analyzer performs chemical determination of HDL cholesterol levels. Used in clinical laboratory settings by trained personnel. Output provides quantitative HDL cholesterol concentration; assists clinicians in lipid profile assessment and coronary artery disease risk stratification.

Clinical Evidence

No clinical data provided; device relies on established chemical precipitation and enzymatic measurement principles for HDL cholesterol.

Technological Characteristics

In vitro diagnostic reagent system; utilizes chemical precipitation method to isolate HDL cholesterol; enzymatic colorimetric assay for quantification; designed for use on Cobas Mira automated chemistry analyzers.

Indications for Use

Indicated for the determination of HDL cholesterol in serum or EDTA plasma samples to assess coronary artery disease risk. For in vitro diagnostic use.

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.

Submission Summary (Full Text)

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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

#### Public Health Service

ood and Drug Administr. 2098 Gaither Boad Rockville MD 20850

Mr. Jose A. Montanez Corporate Director, OA/RA Official Correspondent Raichem Div. of Hemagen® Diagnostics, Inc. 9033 Red Branch Road Columbia, MD 21045

k023784 Re:

> Trade/Device Name: Raichem HDL Cholesterol using Cantrol HDL Precipitating Tubes on the Cobas Mira AnayIzer

Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: LBR Dated: December 10, 2002 Received: December 12, 2002

Dear Mr. Montanez:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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#### Device Name:

Raichem HDL Cholesterol using Cantrol HDL Precipitating Tubes on the Cobas Mira Analyzer

## Indication(s) For Use

Raichem Cholesterol Rapid Liquid Reagent may be used with the CANTROL® HDL Cholesterol Precipitating Reagent Tubes to separate and determine HDL cholesterol in serum or EDTA plasma on the Cobas Mira chemistry systems. High-density lipoprotein measurement in conjunction with other lipid determinations has been shown to be useful in assessing the risk of coronary artery disease. For In Vitro Diagnostic Use Only.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Alan Cooper

(Division Sign-Off)
Division of Clinical Laborato

510(k) Number K023784

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter-Use_