QUANTA PLEX ENA PROFILE 5

K030681 · Inova Diagnostics, Inc. · LLL · Apr 24, 2003 · Immunology

Device Facts

• Record ID: K030681
• Device Name: QUANTA PLEX ENA PROFILE 5
• Applicant: Inova Diagnostics, Inc.
• Product Code: LLL · Immunology
• Decision Date: Apr 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

The QUANTA Plex™ ENA Profile 5 is a fluorescent immunosorbent assay for the semi-quantitative detection of Sm, RNP, SSA, SSB and Sc1-70 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 and scleroderma.

Device Story

QUANTA Plex™ ENA Profile 5 is a fluorescent immunosorbent assay (FISA) used in clinical laboratories. It detects specific autoantibodies (Sm, RNP, SSA, SSB, Scl-70) in human serum samples. The assay provides semi-quantitative results to assist physicians in diagnosing systemic lupus erythematosus, Sjögren's syndrome, and scleroderma. Results are interpreted alongside clinical findings and other laboratory tests to support clinical decision-making.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on analytical performance and technological characteristics typical of fluorescent immunosorbent assays.

Technological Characteristics

Fluorescent immunosorbent assay (FISA) for semi-quantitative detection of autoantibodies. Utilizes specific antigens (Sm, RNP, SSA, SSB, Scl-70) immobilized on a solid phase. Detection relies on fluorescent labeling and measurement. In vitro diagnostic device for professional use.

Indications for Use

Indicated for semi-quantitative detection of Sm, RNP, SSA, SSB, and Scl-70 autoantibodies in human serum to aid in the diagnosis of systemic lupus erythematosus, Sjögren's syndrome, and scleroderma in patients presenting with clinical symptoms of connective tissue disease.

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

Public Health Service

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 2 4 2003

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

Re: k030681

Trade/Device Name: QUANTA Plex™ ENA Profile 5 Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear Antibody Immunological Test System Regulatory Class: Class II Product Code: LLL Dated: March 3, 2003 Received: March 5, 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 vour 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). Other general information on your responsibilities under the Act may be obtained 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):** K030681

Device Name: QUANTA Plex™ ENA Profile 5

## Indications For Use:

The QUANTA Plex™ ENA Profile 5 is a fluorescent immunosorbent assay for the semi-quantitative detection of Sm, RNP, SSA, SSB and Sc1-70 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 and scleroderma.

J.P. Reeves for J. Bautista

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K030681

(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)