QUANTA LITE RF IGA ELISA

K983084 · Inova Diagnostics, Inc. · DHR · Nov 4, 1998 · Immunology

Device Facts

• Record ID: K983084
• Device Name: QUANTA LITE RF IGA ELISA
• Applicant: Inova Diagnostics, Inc.
• Product Code: DHR · Immunology
• Decision Date: Nov 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5775
• Device Class: Class 2

Intended Use

The QUANTA Lite™ RF IgA ELISA is a semiquantitative enzymelinked immunosorbent assay (ELISA) for the detection of IgA 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 Story

QUANTA Lite™ RF IgA ELISA is an in vitro diagnostic test for detecting IgA rheumatoid factor antibodies in patient serum samples. The device utilizes enzyme-linked immunosorbent assay (ELISA) technology to provide semiquantitative results. It is intended for use in clinical laboratory settings by trained laboratory personnel. The output is used by physicians as an aid in the diagnosis of rheumatoid arthritis, alongside other clinical and laboratory data, to support clinical decision-making and patient management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Semiquantitative enzyme-linked immunosorbent assay (ELISA) for IgA rheumatoid factor detection. In vitro diagnostic device, class II, product code DHR.

Indications for Use

Indicated for the detection of IgA rheumatoid factor (RF) antibodies in patient sera to aid in the diagnosis of rheumatoid arthritis (RA) when used with other clinical and laboratory findings.

Regulatory Classification

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.

Submission Summary (Full Text)

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## 4 1998 NOV

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K983084 Re : Trade Name: QUANTA Lite™ RF IgA ELISA Requlatory Class: II Product Code: DHR September 2, 1998 Dated: 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 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 aqainst 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 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 requlatory action. In addition, FDA may publish further announcements 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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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 Toutman

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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510(k) Number (if known): K 983084

Device Name: QUANTA Lite™ RF IgA ELISA

Indications For Use:

The QUANTA Lite™ RF IgA ELISA is a semiquantitative enzymelinked immunosorbent assay (ELISA) for the detection of IgA 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).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <img alt="Signature" src="signature.jpg" width="200"/> |
|-----------------------------------------|--------------------------------------------------------|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K983084 |

| Prescription Use | OR | Over-The-Counter Use |
|-----------------------------------------------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | (Optional Format 1-2-96) |
| <div> <img alt="Check Mark" src="check_mark.jpg"/> </div> | | |