IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA

K032571 · Immco Diagnostics, Inc. · MVM · Dec 24, 2003 · Immunology

Device Facts

• Record ID: K032571
• Device Name: IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA
• Applicant: Immco Diagnostics, Inc.
• Product Code: MVM · Immunology
• Decision Date: Dec 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

An enzyme linked immunosorbent assay (ELISA) for the detection and semi-quantitation of anti-human Tissue Transglutaminase IgA antibodies in human serum to aid in the diagnosis of patients with celiac disease and dermatitis herpetiformis

Device Story

ImmuLisa Anti-human tissue Transglutaminase (human tTG) IgA ELISA is an in vitro diagnostic test. It utilizes enzyme-linked immunosorbent assay (ELISA) technology to detect and semiquantify IgA antibodies against human tissue transglutaminase in patient serum. The device is intended for use by clinical laboratory professionals to aid in the diagnosis of Gluten Sensitive Enteropathy, including Celiac Disease and Dermatitis herpetiformis. Results are interpreted by clinicians in conjunction with other clinical findings to support a diagnosis.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

Solid-phase ELISA; microwells coated with recombinant human tTG antigen. Detection via Alkaline Phosphatase-conjugated anti-human IgA and pNPP substrate. Requires microplate reader (405 nm) and automatic washer. Semi-quantitative output. Reagents provided in kit format for 96 determinations.

Indications for Use

Indicated for the detection and semiquantitation of IgA antibodies to human tissue transglutaminase in patients suspected of having Gluten Sensitive Enteropathy (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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 4 2003

Mr. Kevin J. Lawson Director of Regulatory Affairs IMMCO Diagnostics 60 Pineview Drive Buffalo, NY 14228

Re: k032571

> Trade/Device Name: ImmuLisa Anti-human tissue Transglutaminase (human tTG) IgA ELISA Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MVM Dated: November 21, 2003 Received: December 10, 2003

Dear Mr. Lawson:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 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) 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 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/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): KØ32 ST)

Device Name: ImmuLisa Anti-human tissue Transglutaminase (human tTG) IgA ELISA

Indications For Use: An enzyme linked immunoassay (ELISA) for the detection and semiquantitation of IgA antibodies to human tissue transglutaminase, as an aid in diagnosing patients with Gluten Sensitive Enteropathy (celiac Disease and Dematitis herpetiformis)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ ﺮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴ (Per 21 CFR 801.109)

OR Over-The-Counter Use (Optional Format 1-2-96)

Mama Mc Clan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_032571