NOVA LITE ENDOMYSIAL

K980312 · Inova Diagnostics, Inc. · DBL · Apr 2, 1998 · Immunology

Device Facts

• Record ID: K980312
• Device Name: NOVA LITE ENDOMYSIAL
• Applicant: Inova Diagnostics, Inc.
• Product Code: DBL · Immunology
• Decision Date: Apr 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

An indirect immunofluorescent antibody test for the qualitative and semi-quantitative detection of IgA class endomysial autoantibodies (EMA) in human serum as an aid in the diagnosis of celiac disease and dermatitis herpetiformis.

Device Story

NOVA Lite™ Endomysial Antibody Test Kit is an indirect immunofluorescent (IIF) assay. It utilizes human serum samples to detect IgA class endomysial autoantibodies. The test is performed in a clinical laboratory setting by trained laboratory personnel. The procedure involves incubating patient serum with substrate tissue; if EMA is present, it binds to the endomysium. A fluorescently labeled anti-human IgA conjugate is then added, which binds to the EMA. The slide is examined using a fluorescence microscope. The presence of characteristic fluorescence patterns indicates a positive result. Results are used by clinicians as an aid in diagnosing celiac disease and dermatitis herpetiformis, supporting clinical decision-making alongside patient history and other diagnostic findings.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on bench testing and performance characteristics typical for this class of in vitro diagnostic device.

Technological Characteristics

Indirect immunofluorescent (IIF) assay. Components include substrate slides, fluorescently labeled anti-human IgA conjugate, and control sera. Operates via antigen-antibody binding detected by fluorescence microscopy. Manual test format.

Indications for Use

Indicated for qualitative and semi-quantitative detection of IgA class endomysial autoantibodies (EMA) in human serum to aid in the diagnosis of celiac disease and dermatitis herpetiformis.

Regulatory Classification

Identification

A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Brys Mvers Regulatory Affairs INOVA Diagnostics, Inc. 10180 Scripps Ranch Blvd. San Diego, CA 92131-1234

APR - 2 1998

K980312 Trade Name: NOVA Lite™ Endomysial Antibody Test Kit Regulatory Class: II Product Code: DBL Dated: January 23, 1998 Received: January 27, 1998

Dear Mr. Myers:

Re:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Autman

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):_K980312

g Test Device Name: NOVA Lomy sial

Indications For Use:

An indirect immunofluorescent antibody test for the qualitative and semi-quantitative detection of IgA class endomysial autoantibodies (EMA) in human serum as an aid in the diagnosis of celiac disease and dermatitis herpetiformis.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K980312

Prescription Use-V
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

(Optional Format 1-2-96)