ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT

K971902 · Roche Diagnostic Systems, Inc. · LBS · Jun 16, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971902
• Device Name: ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT
• Applicant: Roche Diagnostic Systems, Inc.
• Product Code: LBS · Clinical Chemistry
• Decision Date: Jun 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

The Roche UNIMATE HDL Direct reagent is an in vitro diagnostic test for the quantitative determination of High Density Lipoprotein Cholesterol (HDL CHOL) in serum. The Roche Calibrator HDL Direct is intended for use as calibrator in quantitative High Density Lipoprotein Cholesterol (HDL CHOL) assays.

Device Story

Roche UNIMATE HDL Direct reagent and Roche Calibrator HDL Direct are in vitro diagnostic products. Reagent enables quantitative measurement of HDL cholesterol in serum samples; calibrator provides reference values for assay standardization. Used in clinical laboratories by trained personnel. Output is a numerical concentration value of HDL cholesterol, assisting clinicians in assessing lipid profiles and cardiovascular risk. Benefits include accurate, automated quantification of HDL cholesterol levels to support patient management.

Technological Characteristics

In vitro diagnostic reagent and calibrator for HDL cholesterol quantification. Chemical-based assay principle. Intended for use with clinical chemistry analyzers.

Indications for Use

Indicated for the quantitative determination of High Density Lipoprotein Cholesterol (HDL CHOL) in human serum for diagnostic purposes. Intended for professional use in clinical laboratory settings.

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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JUN 16

Food and Drug Administration . 2098 Gaither Road Rockville MD 20850

James W. Haynes Regulatory Affairs Associate Roche Diaqnostic Systems, Inc. 1080 U.S. Highway 202 08876-3771 Branchburg, New Jersey

K971902 Re : Roche UNIMATE HDL Direct Reagent, Roche Calibrator HDL Direct Regulatory Class: II Product Code: LBS Dated: March 24, 1997 Received: March 25, 1997

Dear Mr. Wesolowski:

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 (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 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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510(k) Number (if known)

Device Name: Roche UNIMATE HDL Direct reagent Roche Calibrator HDL Direct

Indications for Use:

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- 1. The Roche UNIMATE HDL Direct reagent is an in vitro diagnostic test for the quantitative determination of High Density Lipoprotein Cholesterol (HDL CHOL) in serum.
- 2. The Roche Calibrator HDL Direct is intended for use as calibrator in quantitative High Density Lipoprotein Cholesterol (HDL CHOL) assays.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)