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

K040095 · Immco Diagnostics, Inc. · MVM · Mar 5, 2004 · Immunology

Device Facts

• Record ID: K040095
• Device Name: IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA
• Applicant: Immco Diagnostics, Inc.
• Product Code: MVM · Immunology
• Decision Date: Mar 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

ImmuLisa™ Anti-Human Tissue Transglutaminase (hu-tTG) Antibody IgG ELISA is an enzyme linked immunosorbent assay (ELISA) for the detection and semi-quantitation of anti-human Tissue Transglutaminase IgG antibodies in human serum to aid in the diagnosis of celiac disease (CD) in patients with IgA deficiency. ImmuLisa™ Anti-Human Tissue Transglutaminase (hu-tTG) Antibody Total IgA/IgG ELISA is an enzyme linked immunosorbent assay (ELISA) for the detection and semi-quantitation of anti-human Tissue Transglutaminase antibodies in human serum to aid in the diagnosis of celiac disease (CD) in patients and dermatitis herpetiformis.

Device Story

The ImmuLisa™ assays are solid-phase ELISA kits used in clinical laboratories to detect anti-human tissue transglutaminase (hu-tTG) antibodies in human serum. The device utilizes microwells coated with recombinant hu-tTG antigen. Patient serum samples, calibrators, and controls are incubated in the wells; anti-hu-tTG antibodies present in the sample bind to the immobilized antigen. After washing to remove unbound proteins, enzyme-labeled anti-human Ig conjugates (IgG or total IgA/IgG) are added. A colorimetric reaction is initiated by adding pNPP substrate, which is converted by the enzyme conjugate. The intensity of the color change, measured via spectrophotometer at 405 nm, is proportional to the concentration of the antibody in the sample. Results are expressed in ELISA units per milliliter (EU/mL). Healthcare providers use these semi-quantitative results to aid in the diagnosis of celiac disease and dermatitis herpetiformis, particularly in patients with IgA deficiency where IgG-class antibodies are the primary marker.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Solid-phase ELISA; microwells coated with recombinant hu-tTG antigen; Alkaline Phosphatase-labeled anti-human Ig conjugates; pNPP substrate; spectrophotometric detection at 405 nm. Requires microplate reader and automatic washer. Semi-quantitative output in EU/mL.

Indications for Use

Indicated for patients suspected of having celiac disease (CD) or dermatitis herpetiformis. The IgG ELISA is specifically indicated for patients with IgA deficiency. The Total IgA/IgG ELISA is indicated for general patient populations and those with 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wavy lines extending from its body.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR - 5 2004

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

k040095 Re:

Trade/Device Name: ImmuLisa Anti-human tissue Transglutaminase (human tTG) IgG ELISA Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MVM Dated: February 20, 2004 Received: February 24, 2004

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, 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 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 practicc 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 premaince modicate 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, 11 Juestions 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 I va inay 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,

Joseph L. Hackett

Joseph L. Hackett, Ph.D. Acting 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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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K_ 0400 96

K. 640096

Device Name:

ImmuLisa Anti-human tissue Transglutaminase (human tTG) IgG ELISA

An enzyme linked immunoassay (ELISA) for the detection and semi-Indications For Use: quantitation of anti-human Tissue Transglutaminase IgG antibodies in human serum to aid in the diagnosis of celiac disease (CD) in patients with IgA deficiency.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

ﮯ

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

Maria Chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040091

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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K.DY0095____________________________________________________________________________________________________________________________________________

ImmuLisa Anti-human tissue Transglutaminase (hu tTG) Total Device Name: IgA/IgG Antibody ELISA

Indications For Use: An enzyme linked immunoassay (ELISA) for the detection and An chilymo intitled of IgA and IgG antibodies to human tissue semi-quantitation of ig/Pana is ci citia in diagnosis of Celiac Disease (CD).

(Please DO NOT WRITE BE'LOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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

Prescription Use (Per 21 CFR 801.109)

.

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

Maria Chan
Division Sign-Off

.Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040095