AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA

K033744 · Hycor Biomedical , Ltd. · MVM · Jan 20, 2004 · Immunology

Device Facts

• Record ID: K033744
• Device Name: AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA
• Applicant: Hycor Biomedical , Ltd.
• Product Code: MVM · Immunology
• Decision Date: Jan 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgA autoantibodies to tissue transglutaminase (tTg) in human serum. The results of the anti-tTg assay can be used as an aid in the diagnosis of autoimmune diseases with elevated levels of anti-tTg antibodies including Coeliac Disease. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regimen. This device can be used with HYCOR HY.TEC automated EIA instrument. For in vitro diagnostic use only.

Device Story

Solid phase ELISA for detection of anti-tTg IgA antibodies in human serum; utilizes 96-well plates coated with purified tTg antigen. Patient serum added to wells; antibodies bind to antigen; horseradish peroxidase-conjugated anti-IgA antibody added; TMB substrate added to produce colorimetric reaction. Color intensity proportional to autoantibody concentration. Performed manually or automatically via HYCOR HY.TEC instrument; instrument performs dilutions and calculates results. Used in clinical laboratory settings by trained personnel. Output provides semi-quantitative antibody levels to assist clinicians in multi-factorial diagnostic regimens for autoimmune conditions like Coeliac Disease.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Solid phase ELISA; 96-well microplate coated with purified tTg antigen. Detection via horseradish peroxidase-conjugated anti-IgA antibody and TMB substrate. Manual or automated (HY.TEC instrument) operation. Semi-quantitative output. No international reference standard available; arbitrary units assigned and verified against internal controls.

Indications for Use

Indicated for semi-quantitative determination of specific IgA autoantibodies to tissue transglutaminase (tTg) in human serum as an aid in the diagnosis of autoimmune diseases associated with elevated anti-tTg levels, including Celiac disease.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract design of an eagle with three heads, symbolizing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

ed

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Danielle M. Knight Quality Manager Hycor Biomedical Limited Pentlands Science Park Bush Loan Penicuik EH26 OPL United Kingdom

> k033744 Trade/Device Name: Autostat II Anti-tTg IgA ELISA Regulation Number: 21 CFR § 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: II Product Code: MVM Dated: January 6, 2004

Dear Mr. Knight:

Received: January 8, 2004

Re:

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.

JAN 2 0 2004

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 docs 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); labcling (21 CFR Parts 801 and 809); 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 devicc 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.

{1}------------------------------------------------

Page 2 –

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,

itwen Sutman

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

{2}------------------------------------------------

## Indications for Use.

Enzyme linked immunosorbent assay method for the scmi-quantitative determination specific IgA autoantibodies to tissue transglutaminase (tTg) in human securi.

Uses:

The results of the anti-tTg assay can be used as an aid in the diagnosis of auto-immun diseases associated with elevated levels of anti-tTg antibodies including Coeliac Discuss a Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regine.

This device can be used with the HYCOR HY.TEC automated EIA instrument.

For in vitro diagnostic use only.

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

H. Reeves for T. J. O'Leary
**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K033744