RDI DIRECT LDL CHOLESTEROL TEST

K984107 · Reference Diagnostics, Inc. · MRR · Jan 28, 1999 · Clinical Chemistry

Device Facts

• Record ID: K984107
• Device Name: RDI DIRECT LDL CHOLESTEROL TEST
• Applicant: Reference Diagnostics, Inc.
• Product Code: MRR · Clinical Chemistry
• Decision Date: Jan 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

For use in clinical laboratories and physicians' office laboratories for quantitative determination of low density lipoprotein (LDL) cholesterol in human serum as a risk factor in coronary artery disease.

Device Story

RDI Direct LDL Reagent is an in vitro diagnostic reagent for quantitative measurement of LDL cholesterol in human serum. Used in clinical and physicians' office laboratories by laboratory personnel. The assay provides a direct measurement of LDL cholesterol, which clinicians use to assess coronary artery disease risk. The output is a numerical concentration value, aiding in patient lipid profile management and cardiovascular risk stratification.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on 510(k) regulatory review.

Technological Characteristics

In vitro diagnostic reagent for quantitative chemical analysis of human serum. Principle of operation involves direct LDL cholesterol determination. No specific materials, software, or connectivity described.

Indications for Use

Indicated for quantitative determination of LDL cholesterol in human serum for patients being assessed for coronary artery disease risk. For use in clinical and physicians' office laboratories.

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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JAN 28 1999

Joseph Lawlor, Ph.D. President Reference Diagnostics, Inc. 23 Crosby Drive Bedford, Massachusetts 01730-1401

K984107 Re: Trade Name: RDI Direct LDL Reagent Regulatory Class: I Product Code: MRR Dated: November 16, 1998 Received: November 17, 1998

Dear Dr. Lawlor:

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.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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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 Sutman

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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## INDICATIONS FOR USE

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510(k) Number (if known): K984107

Device Name: RDI Direct LDL Cholesterol Test

Indications For Use:

For use in clinical laboratories and physicians' office laboratories for quantitative determination of low density lipoprotein (LDL) cholesterol in human serum as a risk factor in coronary artery disease.

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510(k) Number K984/07

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

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