QUANTA LITE PBC SCREEN IGG/IGA ELISA

K061842 · Inova Diagnostics, Inc. · NRI · Oct 18, 2006 · Immunology

Device Facts

• Record ID: K061842
• Device Name: QUANTA LITE PBC SCREEN IGG/IGA ELISA
• Applicant: Inova Diagnostics, Inc.
• Product Code: NRI · Immunology
• Decision Date: Oct 18, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5090
• Device Class: Class 2

Intended Use

The QUANTA Lite™ PBC Screen IgG/IgA ELISA is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of anti-mitochondrial antibodies, gp210 antibodies, and sp100 antibodies of the IgG and/or IgA class in human serum. The presence of mitochondrial, gp210, and sp100 antibodies can be used in conjunction with clinical findings as an aid in the diagnosis of primary biliary cirrhosis.

Device Story

QUANTA Lite™ PBC Screen IgG/IgA ELISA is an in vitro diagnostic assay for human serum samples. It utilizes enzyme-linked immunosorbent assay (ELISA) technology to detect specific autoantibodies (anti-mitochondrial, gp210, and sp100) associated with primary biliary cirrhosis. Performed in clinical laboratories by trained technicians; results are interpreted by physicians in conjunction with clinical findings to support diagnosis. The assay provides semi-quantitative data, assisting clinicians in identifying autoimmune markers indicative of liver disease.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on bench testing and performance characteristics typical of ELISA-based immunological assays.

Technological Characteristics

Semi-quantitative ELISA; polystyrene microplate with breakaway 12x8 microwells; antigens: recombinant MIT3, synthetic gp210, synthetic sp100; enzyme-conjugate: HRP-labeled goat anti-human IgG/IgA; substrate: TMB chromogen; stop solution: 0.344M sulfuric acid; detection: spectrophotometric OD at 450/620 nm; manual/automated plate reader required.

Indications for Use

Indicated for use in patients suspected of having primary biliary cirrhosis (PBC) to aid in diagnosis via detection of anti-mitochondrial, anti-gp210, and anti-sp100 antibodies in human serum.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

INOVA Diagnostics, Inc. c/o Gary L. Norman, Ph.D. Senior Scientist 9900 Old Grove Rd. San Diego, CA 92131-1638

OCT 1 8 2006

Re: k061842

Trade/Device Name: QUANTA Lite™ PBC Screen IgG/IgA ELISA Regulation Number: 21 CFR 866.5090 Regulation Name: Anti-mitochondrial Antibody Immunological Test System Regulatory Class: Class II Product Code: DBM, NRI, NUM Dated: June 22, 2006 Received: June 29, 2006

Dear Dr. Norman:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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/industry/support/index.html.

Sincerely yours,

Robert A. Beckerf

Robert L. Becker, Jr., M.D., Pb.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety

Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): k061842

Device Name:_QUANTA Lite™ PBC Screen IgG/IgA ELISA

Indications for Use:

The QUANTA Lite™ PBC Screen IgG/IgA ELISA is an enzyme-ilnked immunosorbent The QUANTA Lite - FDC Sciech ighty - Enon roomitochondrial antibodies, gp210
assay (ELISA) for the semi-quantitative detection of mitochen in human sorum. The assay (ELISA) for the Semi-quantitic tre lgG and/or lgA class in human serum. The antibodies, and sp100 antibodies of the ige androing. I scan be used in conjunction presence of millochondrial, gp210, and op roo antiboures of primary biliary cirrhosis.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write Below This Line-Continue on Another Page if NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Maria Chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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