QUANTA LITE RF IGG ELISA by INOVA DIAGNOSTICS, INC.

QUANTA Lite™ RF IgG ELISA is a semiquantitative enzyme-The linked immunosorbent assay (ELISA) for the detection of IgG rheumatoid factor (RF) antibodies in patient sera. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of rheumatoid arthritis (RA).

Device Description

QUANTA Lite™ RF IgG ELISA is a semiquantitative enzyme-The linked immunosorbent assay (ELISA)

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the QUANTA Lite™ RF IgG ELISA device. It declares the device substantially equivalent to a legally marketed predicate device for aiding in the diagnosis of rheumatoid arthritis.

However, the document does not contain the detailed information necessary to answer your request regarding acceptance criteria and the specifics of the study that proves the device meets those criteria, such as:

A table of acceptance criteria and reported device performance: This information is typically found in the scientific study report or the 510(k) submission's performance data section, not in the clearance letter itself.
Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set size, and how training ground truth was established. These are all specific details about the clinical or analytical validation studies, which are not included in this FDA clearance letter.

This document is a formal notification of market clearance based on the FDA's review of the applicant's submission. It confirms that the FDA found the device "substantially equivalent" to an existing product for the stated "Indications For Use," meaning the company provided data (in a separate submission) that supported this claim.

To answer your question, you would need to consult the actual 510(k) submission (K983083, though the enclosure references K982883) or the underlying study reports, which are not provided here.

Summary

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle.

4 1998 NOV

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Brys C. Myers Manager, Requlatory Affairs INOVA Diagnostics, Inc. 10180 Scripps Ranch Boulevard San Diego, California 92131-1234

Re : K983083 Trade Name: QUANTA Lite™ RF IgG ELISA Requlatory Class: II Product Code: DHR Dated: September 2, 1998 Received: September 3, 1998

Dear Mr. Myers:

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 qeneral 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 regulations 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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 requlation may result in requlatory 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 obliqation 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.

{1}------------------------------------------------

Page 2

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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

{2}------------------------------------------------

Page 5 of 32

510(k) Number (if known):

Device Name: QUANTA Lite™ RF IQG ELISA

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tita E. Masini

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number: K982883

Prescription Use √
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 866.5775 Rheumatoid factor immunological test system.

(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).