VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT

K984303 · Ortho-Clinical Diagnostics, Inc. · LBR · Jan 28, 1999 · Clinical Chemistry

Device Facts

• Record ID: K984303
• Device Name: VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: LBR · Clinical Chemistry
• Decision Date: Jan 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

For in vitro diagnostic use only. The VITROS Magnetic HDL reagent and VITROS Cholesterol slides quantitatively measure HDL-cholesterol (HDLC) in serum and plasma.

Device Story

Device consists of VITROS Chemistry Products Magnetic HDL-Cholesterol Reagents and VITROS Chemistry Products Calibrator Kit. Used for in vitro diagnostic quantitative measurement of HDL-cholesterol in serum and plasma. Operates on VITROS Chemistry Systems; utilizes magnetic separation technology to isolate HDL-cholesterol. Intended for use by clinical laboratory professionals. Output provides numerical HDL-cholesterol concentration values. Clinicians use results to assess coronary heart disease (CHD) risk; lower concentrations correlate with increased risk. Facilitates patient risk stratification and management.

Clinical Evidence

No clinical data provided; device relies on analytical performance characteristics for substantial equivalence.

Technological Characteristics

In vitro diagnostic reagent and calibrator kit. Utilizes magnetic separation principle for HDL-cholesterol isolation. Designed for use with VITROS Chemistry Systems. No specific materials or software architecture details provided.

Indications for Use

Indicated for the quantitative measurement of HDL-cholesterol (HDLC) in human serum and plasma to evaluate the risk of developing coronary heart disease (CHD).

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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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the bird.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 28 1999

Ms. Marlene A. Shulman Regulatory Affairs Associate Ortho-Clinical Diagnostics A•Johnson & Johnson Company 100 Indigo Creek Drive Rochester, New York 14626-5101

Re: K984303

Trade Name: VITROS Chemistry Products Magnetic HDL Cholesterol Reagents and VITROS Chemistry Products Calibrator Kit 2 Product Code: LBR Regulatory Class: I 112 II Dated: December 1, 1998 Received: December 2, 1998

Dear Ms. Shulman:

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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations 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 requirements, 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 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 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/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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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### Statement of Intended Use

## Page 1 of 1

510(k) Number (if known): K984305

VITROS Chemistry Products Magnetic HDL-Cholesterol Reagent. Device Name:

Indications for Use:

Intended Use:

For in vitro diagnostic use only. The VITROS Magnetic HDL reagent and VITROS Cholesterol slides quantitatively measure HDL-cholesterol (HDLC) in serum and plasma.

## Summary and Explanation of the Test:

HDL-cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with lower HDL-cholesterol concentrations.

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Concurrence of CDRH. Office of Device Evaluation (ODE)

Sean Cooper

ision Sign-Off ivision of Clinical Laboratory Devices 984 30 m 510(k) Number

> Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _

(Optional Format 1-2-96)