QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA

K021648 · Inova Diagnostics, Inc. · NJF · Sep 20, 2002 · Immunology

Device Facts

• Record ID: K021648
• Device Name: QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA
• Applicant: Inova Diagnostics, Inc.
• Product Code: NJF · Immunology
• Decision Date: Sep 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5120
• Device Class: Class 2

Intended Use

The QUANTA Lite™ Actin ELISA kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of IgG antibodies to the actin component of smooth muscle in human serum. Detection of these antibodies is an aid in diagnosis of certain autoimmune liver diseases such as autoimmune hepatitis (AIH) and primary biliary cirrhosis (PBC).

Device Story

QUANTA Lite™ Actin ELISA is an in vitro diagnostic test for human serum samples. It utilizes enzyme-linked immunosorbent assay (ELISA) technology to detect IgG antibodies targeting actin, a component of smooth muscle. The assay is performed in a clinical laboratory setting by trained personnel. The test provides semi-quantitative results, which are interpreted by healthcare providers to assist in the clinical diagnosis of autoimmune liver diseases, specifically autoimmune hepatitis and primary biliary cirrhosis. The device aids in clinical decision-making by identifying specific autoantibodies associated with these conditions.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) for semi-quantitative detection of IgG antibodies. In vitro diagnostic test system. Class II device, product code NJF.

Indications for Use

Indicated for the semi-quantitative detection of IgG antibodies to actin in human serum to aid in the diagnosis of autoimmune liver diseases, including autoimmune hepatitis (AIH) and primary biliary cirrhosis (PBC).

Regulatory Classification

Identification

An antismooth muscle antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antismooth muscle antibodies (antibodies to nonstriated, involuntary muscle) in serum. The measurements aid in the diagnosis of chronic hepatitis (inflammation of the liver) and autoimmune connective tissue diseases (diseases resulting from antibodies produced against the body's own tissues).

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

SEP 2 0 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

k021648 Re: Trade/Device Name: QUANTA Lite™ Actin ELISA Regulation Number: 21 CFR § 866.5120 Regulation Name: Anti-smooth Muscle Antibody Immunological Test System Regulatory Class: II Product Code: NJF Dated: July 29, 2002 Received: July 29, 2002

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. Iisting 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 mav 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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**510(k) Number (if known):** K021648

Device Name: QUANTA Lite™ Actin ELISA

## Indications For Use:

The QUANTA Lite™ Actin ELISA kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of IgG antibodies to the actin component of smooth muscle in human serum. Detection of these antibodies is an aid in diagnosis of certain autoimmune liver diseases such as autoimmune hepatitis (AIH) and primary biliary cirrhosis (PBC).

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Deborah M. Moore
(Division Sign-Off)

ation of Clinical Laboratory Division of Clinical

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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