QUANTA LITE GP210 ELISA

K040885 · Inova Diagnostics, Inc. · NRI · Jun 25, 2004 · Immunology

Device Facts

• Record ID: K040885
• Device Name: QUANTA LITE GP210 ELISA
• Applicant: Inova Diagnostics, Inc.
• Product Code: NRI · Immunology
• Decision Date: Jun 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5090
• Device Class: Class 2

Intended Use

The QUANTA Lite™ gp210 kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of anti-gp210 antibody of the IgG class in human serum. The test is intended to aid in the diagnosis of primary biliary cirrhosis (PBC).

Device Story

The QUANTA Lite gp210 ELISA is an in vitro diagnostic test for human serum samples. It utilizes a polystyrene microwell plate coated with purified gp210 peptide antigen. Patient serum is added to the wells; if anti-gp210 antibodies are present, they bind to the immobilized antigen. After washing, a goat anti-human IgG horseradish peroxidase conjugate is added, followed by a TMB chromogen substrate. The resulting color intensity is measured spectrophotometrically at 450nm and 620nm using a microwell plate reader. The device is intended for use in clinical laboratories by trained personnel. Results are reported in arbitrary units and interpreted as negative, equivocal, or positive. The assay aids clinicians in diagnosing PBC, particularly by identifying a subpopulation of patients who may test negative for anti-mitochondrial antibodies (AMA) or M2 antibodies, thereby increasing overall diagnostic sensitivity when used in combination with other tests.

Clinical Evidence

No clinical data provided in the summary document; device clearance based on analytical performance and substantial equivalence to existing immunological test systems.

Technological Characteristics

Semi-quantitative ELISA; polystyrene microwell plate solid phase; purified gp210 peptide antigen; goat anti-human IgG horseradish peroxidase conjugate; TMB chromogen substrate. Requires spectrophotometric plate reader (450nm/620nm). Serum matrix. Manual/semi-automated processing.

Indications for Use

Indicated for the semi-quantitative detection of IgG class anti-gp210 antibodies in human serum to aid in the diagnosis of primary biliary cirrhosis (PBC). For prescription use only.

Regulatory Classification

Identification

An antimitochondrial antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own tissue), such as primary biliary cirrhosis (degeneration of liver tissue) and chronic active hepatitis (inflammation of the liver).

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 U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## JUN 2 5 2004

Gary L. Norman, Ph.D. Senior Scientist 10180 Scripps Ranch Blvd. San Diego, CA 92131-1234

Re: k040885

Trade/Device Name: QUANTA Lite™ gp210 ELISA Regulation Number: 21 CFR 866.5090 Regulation Name: Antimitochondrial antibody immunological test system Regulatory Class: Class II Product Code: NRI Dated: May 21, 2004 Received: June 1, 2004

Dear Dr. Norman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bection brokey personally equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars) to regars and the Medical Device Amendments, or to commerce proc to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, de vices that have been receasined in quire approval of a premarket approval application (PMA). and Cosmetic Act (11ct) that to hor requestly of the general controls provisions of the Act. The 1 out may, mercrore, market and act include requirements for annual registration, listing of general controls provisions of the riot 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 In may be subject to such additional come Regulations (CFR), Parts 800 to 895. In addition, FDA can be found in This 21, overments concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Ficase oe advised that I Dri 3 issuance or our device complies with other requirements of the Act that I DA has made a dolorimiation administered by other Federal agencies. You must of ally if ederal statutes and regulations and limited to: registration and listing (21 comply with an the 110 - 115 - 11 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 his letter will anow you to oegin maneting your and equivalence of your device to a legally prematket notification: "The PDF inturly 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, If you desire specific mornation as advertising of your device, please contact the Office of In of questions on the promotion and Safety at [phone]. Also, please note the v itto Diagnostic Derreo Branding by reference to premarket notification" (21CFR Part 807.97). regulation entitled, "Misoranams" "Misormation on your responsibilities under the Act from the Tou may oount other general results 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,

Robert L. Becker

Robert L. Becker, Jr., MD, Ph.D 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): ____________________________________________________________________________________________________________________________________________________

## Device Name: QUANTA Lite™ gp210 ELISA

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## Indications For Use:

The QUANTA Lite™ gp210 kit is an enzyme-linked immunosorbent assay (ELISA) for The QUANTA Lite - gp210 kit is an eneyno infoody of the IgG class in human serum.
the semi-quantitative detection of anti-gp210 antibody of the IgG cass in human serum.
In an the semi-quartified to aid in the diagnosis of primary biliary cirrhosis (PBC).

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OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Maria Chan

**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040885

Prescription Use_✓ (Per 21 CFR 801.109)

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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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