RDI HOMOGENEOUS HDL CHOLESTEROL TEST

• K Number: K973988
• Device Name: RDI HOMOGENEOUS HDL CHOLESTEROL TEST
• Manufacturer: REFERENCE DIAGNOSTICS, INC.
• Date Cleared: 1997-12-22 ( 62 days)
• Product Code: LBS , JHM , LBR
• Regulation Number: 862.1475
• Type: Traditional
• Panel: Clinical Chemistry
• Reference & Predicate Devices: N/A
• Predicate For: N/A

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 Description

Not Found

AI/ML Overview

This is a 510(k) Premarket Notification for the "RDI Homogeneous HDL Cholesterol Test", cleared in 1997. The available document is the FDA's clearance letter and the "Indications for Use" statement.

Unfortunately, this document does not contain the detailed study information required to answer your request about acceptance criteria and device performance.

The FDA 510(k) clearance process historically relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials for efficacy and safety like a PMA (Premarket Approval) process. While a 510(k) submission typically includes performance data, that data is not included in the provided clearance letter.

Therefore, I cannot provide the specific details you asked for regarding:

1. A table of acceptance criteria and the reported device performance: This information is not in the clearance letter.
2. Sample size used for the test set and the data provenance: Not available in this document.
3. Number of experts used to establish the ground truth... and qualifications: Not available in this document.
4. Adjudication method: Not available in this document.
5. MRMC comparative effectiveness study results: Not applicable as this is not an AI/imaging device and this type of study is for comparing human readers with and without AI assistance.
6. Standalone performance: While the device has standalone performance (as a diagnostic test), the specific metrics are not detailed here.
7. Type of ground truth used: Not available in this document.
8. Sample size for the training set: Not applicable, as this is not an AI/machine learning device that requires a "training set" in the modern sense. It's a chemical assay.
9. How the ground truth for the training set was established: Not applicable.

The document only states the device's 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."

Summary

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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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping heads or faces.

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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[X-1]

INDICATIONS FOR USE

Page 1 of 1

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)

1. 1. 1. 1

Regulation Number and Section

§ 862.1475 Lipoprotein test system.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.