IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA

K091520 · Immco Diagnostics, Inc. · MVM · Mar 10, 2010 · Immunology

Device Facts

• Record ID: K091520
• Device Name: IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA
• Applicant: Immco Diagnostics, Inc.
• Product Code: MVM · Immunology
• Decision Date: Mar 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

Enzyme linked immunoassays (ELISA) for the qualitative and semiquantitative detection of anti-human Tissue Transglutaminase IgA or IgG antibodies in human serum to aid in the diagnosis of gluten sensitive enteropathy / celiac disease (CD) in conjunction with other laboratory and clinical findinas.

Device Story

ImmuLisa Celiac tTG ELISA kits detect anti-human tissue transglutaminase (tTG) IgA or IgG antibodies in human serum samples. The device utilizes enzyme-linked immunosorbent assay (ELISA) technology to identify specific autoantibodies associated with celiac disease. Used in clinical laboratory settings by trained technicians; results are interpreted by physicians alongside clinical symptoms and other diagnostic tests to support celiac disease diagnosis. The assay provides qualitative and semiquantitative measurements, assisting in the clinical evaluation of patients suspected of gluten sensitivity.

Clinical Evidence

Clinical study evaluated 185 samples for IgA and 276 samples for IgG. IgA assay sensitivity 94.6% and specificity 94.6% (at 20 EU/mL cutoff). IgG assay sensitivity 54.5% and specificity 95.1% (at 20 EU/mL cutoff). Comparison with predicate showed overall agreement of 88.6% (IgA) and 83.2% (IgG).

Technological Characteristics

Solid-phase ELISA; rh-tTG antigen coated microwells; HRP-conjugated goat anti-human IgA/IgG detection; TMB substrate; spectrophotometric readout at 450 nm. Standards: CLSI EP-17A (LoD/LoQ), CLSI EP-6A (Linearity). Storage 2-8°C. No active electronic components; standalone assay.

Indications for Use

Indicated for the qualitative and semi-quantitative detection of anti-human Tissue Transglutaminase IgA or IgG antibodies in human serum to aid in the diagnosis of gluten sensitive enteropathy / celiac disease (CD) in patients, in conjunction with other laboratory and clinical findings. For prescription use only.

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).

Predicate Devices

• ImmuLisa hu-tTG IgA Antibody ELISA (k032571)
• ImmuLisa hu-tTG IgG Antibody ELISA (k040095)
• ImmuGlo Endomysial Antibody IFA (k912551)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

IMMCO Diagnostics, Inc. c/o Mr. Kevin J. Lawson VP. Regulatory Affairs 60 Pineview Drive Buffalo, NY 14228

## MAR 1 0 2010

Re: k091520

Trade/Device Name: ImmuLisa™ Celiac tTG rHuman Tissue Transglutaminase IgA

Antibody ELISA

ImmuLisaTM Celica tTG rHuman Tissue Transglutaminase IgG Antibody ELISA

Regulation Number: 21 CFR § 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MVM Dated: February 15, 2010 Received: February 16, 2010

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 class II (Special Controls), 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

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Page 2 – Mr. Kevin J. Lawson

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRI-l's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

ia m chan

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K091520

Device Name: ImmuLisa™ Celiac tTG rHuman Tissue Transglutaminase Antibody ELISAs

Indications For Use: Enzyme linked immunoassays (ELISA) for the qualitative and semiquantitative detection of anti-human Tissue Transglutaminase IgA or IgG antibodies in human serum to aid in the diagnosis of gluten sensitive enteropathy / celiac disease (CD) in conjunction with other laboratory and clinical findinas.

Prescription Use __ V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Reena Philip

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510K k091520