QUANTA PLEX SLE PROFILE 8

K040160 · Inova Diagnostics, Inc. · LLL · Mar 8, 2004 · Immunology

Device Facts

• Record ID: K040160
• Device Name: QUANTA PLEX SLE PROFILE 8
• Applicant: Inova Diagnostics, Inc.
• Product Code: LLL · Immunology
• Decision Date: Mar 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

The QUANTA Plex™ SLE Profile 8 is a fluorescent immunosorbent assay for the semi-quantitative detection of autoantibodies in human serum. The assay 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™ SLE Profile 8 is a fluorescent immunosorbent assay (FISA) designed for laboratory use. It analyzes human serum samples to detect specific autoantibodies (Sm, RNP, SSA, SSB, SCL-70, Jo-1, Centromere B, and dsDNA). The device functions by identifying these autoantibodies, providing semi-quantitative results that clinicians use alongside patient clinical findings and other diagnostic tests to support the diagnosis of systemic lupus erythematosus and related connective tissue disorders. It is intended for professional use in a clinical laboratory setting.

Clinical Evidence

Clinical performance evaluated using 424 serum samples (159 SLE, 44 scleroderma, 20 Jo-1, 30 RA, 21 infectious disease, 150 normal). Clinical sensitivity for ribosome-P was 13.8% and chromatin was 42.8% in SLE patients. Clinical specificity was 99.6% for ribosome-P and 97.4% for chromatin in non-SLE patients. Method comparison against predicate ELISA assays showed high agreement (Total agreement 92.4%–98.6%).

Technological Characteristics

Multiplexed fluorescent immunoassay using polystyrene microspheres. Antigens (Sm, RNP, SS-A, SS-B, Scl-70, Jo-1, ribosome-P, chromatin) coupled to unique spectral-addressable beads. Detection via PE-labeled goat anti-human IgG conjugate. Instrument: Luminex 100 System. Dynamic range: 20 to >20,000 Fluorescent Units (FU).

Indications for Use

Indicated for use as an aid in the diagnosis of systemic lupus erythematosus and related connective tissue diseases such as Sjögren’s syndrome, scleroderma and polymyositis.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR - 8 2004

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

Re: k040160

Trade/Device Name: Quanta Plex™ SLE Profile 8 Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: LLL; MQA Dated: January 21, 2004 Received: January 23, 2004

Dear Mr. Myers:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been mined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enational of the enactment date of the Medical Device Amendments, or to conniered prior to ria) 2011-07-11 in accordance with the provisions of the Federal Food, Drug, de vices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Fee (110) in the device, subject to the general controls provisions of the Act. The r ou may, disreleve, mains 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 may or sabject to back acch 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 r head be act mod a determination that your device complies with other requirements of the Act that I Dridana statutes and regulations administered by other Federal agencies. You must or uny I odotal batates as regirements, 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) I mis icher with anow you to oegin finding of substantial equivalence of your device to a legally premarket notineation: "The PDF mailing sification 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 or questions on the promotion and Safety at [phone]. Also, please note the In Viro Diagnostic Do roo 24 and seference to premarket notification" (21 CFR Part 807.97). Tegulation other general information on your responsibilities under the Act from the I bu may ovain out. Beforers, 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,

Joseph L. Hackett

Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology 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): ΚΟΥΟΥ ΟΥ Ο

Device Name: QUANTA Plex™ SLE Profile 8

## Indications For Use:

The QUANTA Plex™ SLE Profile 8 is a fluorescent immunosorbent assay The QUANTA FICX Bib Froition of Sm, RNP, SSA, SSB, SSB, SCL-70, ror the Sem qualcroatin autoantibodies in human serum. The 00 1, Irbooms I and offically can be used in conjunction with preschee of there and other laboratory tests to aid in the ciritical rindings and other them.
diagnosis of systemic lupus erythematosus and related connective diagnosis or bybeemas lapas syndrome, scleroderma and polymyositis.

Frank Chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040160

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_V (Per 21 CFR 801.109) * OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)