QUANTA PLEX ENA PROFILE 6

K031450 · Inova Diagnostics, Inc. · LLL · Jun 25, 2003 · Immunology

Device Facts

• Record ID: K031450
• Device Name: QUANTA PLEX ENA PROFILE 6
• Applicant: Inova Diagnostics, Inc.
• Product Code: LLL · Immunology
• Decision Date: Jun 25, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

The QUANTA Plex™ ENA Profile 6 is a fluorescent immunosorbent assay for the semi-quantitative detection of Sm, RNP, SSA, SSB, Scl-70 and Jo-1 autoantibodies in human serum. The presence of these antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of systemic lupus erythematosus and related connective tissue diseases such as Sjögren's syndrome, scleroderma and polymyositis.

Device Story

QUANTA Plex™ ENA Profile 6 is a fluorescent immunosorbent assay (FISA) for detecting specific autoantibodies (Sm, RNP, SSA, SSB, Scl-70, Jo-1) in human serum. Device used in clinical laboratory settings by trained personnel. Input is human serum sample; assay utilizes fluorescent labeling to detect presence of autoantibodies. Output is semi-quantitative measurement of antibody levels. Results interpreted by clinicians alongside clinical findings and other laboratory tests to support diagnosis of connective tissue diseases. Benefits include improved diagnostic efficiency for systemic autoimmune conditions.

Clinical Evidence

No clinical data provided in the document; substantial equivalence based on bench testing and performance characteristics of the fluorescent immunosorbent assay.

Technological Characteristics

Fluorescent immunosorbent assay (FISA) for semi-quantitative detection of autoantibodies. Analyte targets: Sm, RNP, SSA, SSB, Scl-70, Jo-1. Sample type: human serum. Class II device, product code LLL.

Indications for Use

Indicated for semi-quantitative detection of Sm, RNP, SSA, SSB, Scl-70, and Jo-1 autoantibodies in human serum to aid in diagnosis of systemic lupus erythematosus, Sjögren's syndrome, scleroderma, and polymyositis. For prescription use only.

Regulatory Classification

Identification

An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 5 2003

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

Re: k031450

Trade/Device Name: QUANTA Plex™ ENA Profile 6 Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: LLL Dated: May 6, 2003 Received: May 12, 2003

Dear Mr. Myers:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: QUANTA Plex™ ENA Profile 6

## Indications For Use:

The QUANTA Plex™ ENA Profile 6 is a fluorescent immunosorbent assay for the semi-quantitative detection of Sm, RNP, SSA, SSB, Scl-70 and Jo-1 autoantibodies in human serum. The presence of these antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of systemic lupus erythematosus and related connective tissue diseases such as Sjögren's syndrome, scleroderma and polymyositis.

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

Concurrence of CDRHaOffice of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices

| 510(k) Number | K031458 |
|---------------|---------|
|---------------|---------|

| Prescription Use | <div>✓</div> <div>(Per 21 CFR 801.109)</div> |
|------------------|----------------------------------------------|
|------------------|----------------------------------------------|

OR

| Over-The-Counter Use | |
|----------------------|--|
|----------------------|--|

(Optional Format 1-2-96)
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