RDI HOMOGENEOUS HDL CHOLESTEROL TEST

K973988 · Reference Diagnostics, Inc. · LBS · Dec 22, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973988
• Device Name: RDI HOMOGENEOUS HDL CHOLESTEROL TEST
• Applicant: Reference Diagnostics, Inc.
• Product Code: LBS · Clinical Chemistry
• Decision Date: Dec 22, 1997
• 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 high density lipoprotein (HDL) cholesterol in human serum as a risk factor in coronary artery disease.

Device Story

The RDI Homogeneous HDL Cholesterol Test is an in vitro diagnostic assay used in clinical and physician office laboratories. It quantitatively measures HDL cholesterol levels in human serum samples. The test serves as a diagnostic aid for assessing coronary artery disease risk. Healthcare providers use the resulting cholesterol concentration values to inform clinical decision-making regarding patient cardiovascular health. The device operates via a homogeneous assay method, eliminating the need for manual pretreatment or separation steps typically required in traditional HDL testing.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on bench testing and performance characteristics.

Technological Characteristics

Homogeneous enzymatic assay for HDL cholesterol quantification in human serum. Designed for use in clinical and physician office laboratories. No specific materials, energy sources, or software algorithms are detailed in the provided documentation.

Indications for Use

Indicated for quantitative determination of HDL cholesterol in human serum for patients being assessed for coronary artery disease risk. For use in clinical and physician 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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 2 1997

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

Re : K973988 RDI Homogeneous HDL Cholesterol Test Requlatory Class: I Product Code: JHM, LBR Dated: October 20, 1997 Received: October 21, 1997

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 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, qood 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. ਸ 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 In addition, FDA may publish further announcements action. 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 requlations.

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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 Bitman

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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K9 13988

510(k) Number (if known):

Device Name: RDI Homogeneous HDL Cholesterol Test

Indications For Use:

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

V.M. Grantt for M. Montgomery

(Division Sign-Off)
Division of Clima
evices
510(k) Number K97 3998

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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