QUANTA LITE M2 EP (MIT3) ELISA

K052262 · Inova Diagnostics, Inc. · DBM · Oct 27, 2005 · Immunology

Device Facts

• Record ID: K052262
• Device Name: QUANTA LITE M2 EP (MIT3) ELISA
• Applicant: Inova Diagnostics, Inc.
• Product Code: DBM · Immunology
• Decision Date: Oct 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5090
• Device Class: Class 2

Intended Use

The QUANTA Lite™ M2 EP (MIT3) ELISA is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of mitochondrial antibodies in human serum. The presence of mitochondrial antibodies can be used in conjunction with clinical findings to aid in the diagnosis of primary biliary cirrhosis.

Device Story

The QUANTA Lite™ M2 EP (MIT3) ELISA is an in vitro diagnostic test used in clinical laboratories. It detects mitochondrial antibodies in human serum samples using an enzyme-linked immunosorbent assay (ELISA) format. The assay provides semi-quantitative results that clinicians use alongside other clinical findings to support a diagnosis of primary biliary cirrhosis. The device is intended for prescription use by trained laboratory personnel.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on bench-top performance characteristics of the ELISA methodology.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) for semi-quantitative detection of mitochondrial antibodies. Class II device, product code DBM, regulated under 21 CFR 866.5090.

Indications for Use

Indicated for the semi-quantitative detection of mitochondrial antibodies in human serum to aid in the diagnosis of primary biliary cirrhosis in patients presenting with clinical symptoms.

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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INOVA Diagnostics, Inc. c/o Mr. Brys C. Myers Vice President 9900 Old Grove Rd. San Diego, CA 92131-1638

OCT 2 7 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Re: k052262

R052202
Trade/Device Name: QUANTA Lite™ M2 EP (MIT3) ELISA Regulation Number: 21 CFR 866.5090 Regulation Name: 21 OFF Condrial Antibody Immunological Test System Regulatory Class: Class II Product Code: DBM Dated: August 16, 2005 Received: August 19, 2005

Dear Mr. Myers:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 910(x) presidentially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate sommerce use stated in the encrosure/ to regally manifical Device Amendments, or to devices that prior to May 26, 1770, the chaomism and the provisions of the Federal Food, Drug, and Cosmetic flave been reclassified in accordance nof a premarket approval application (PMA). You may, Act (Act) that do thot require approval controls provisions of the Act. The general therefore, market the act include requirements for annual registration, listing of devices, good controls provisions of the net morade requibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mic existing major regulations affecting your device can be may be subject to such additional controllars. Title 21, Parts 800 to 898. In addition, FDA may publish found in the Oode ents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised mat 1 Dr. 3 issualled be addition of the requirements of the Act or that FDA made a decemination max your reserved by other Federal agencies. You must comply with any Federal Statules and regulations administration of to: registration and listing (21 CFR Part 807); an the Act s requirements, morading, vancerice requirements as set forth in the quality labeling (21 CFR Part 801); good managements of systems (QB) regalises (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to cogal mains of substantial equivalence of your device to legally premarket notification: "The PDF mining sification for your device and thus, permits your device to proceed to the market.

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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/industry/support/index.html

Sincerely yours,

Robert L. Becker Jr.

Robert L. Becker, Jr., MD, PA 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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of ___________________________________________________________________________________________________________________________________________________________________________ Page

510(k) Number (if known): _ __________________________________________________________________________________________________________________________________________________

Device Name: QUANTA Lite™ M2 EP(MIT3) ELISA

## Indications For Use:

: : : . .

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The QUANTA Lite™ M2 EP (MIT3) ELISA is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of mitochondrial antibodies in human serum. (ELIOF) for the comit quantial antibodies can be used in conjunction with clinical The presentee of milloonomal anabo aid in the diagnosis of primary biliary cirrhosis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Marie M. Clark
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 052262

Prescription Use_v (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)