AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA

K043433 · Hycor Biomedical , Ltd. · MVM · Mar 7, 2005 · Immunology

Device Facts

• Record ID: K043433
• Device Name: AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA
• Applicant: Hycor Biomedical , Ltd.
• Product Code: MVM · Immunology
• Decision Date: Mar 7, 2005
• 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 IgG autoantibodies to tissue transglutaminase (tTg) in human serum. Uses: The results of the anti-fTg assay can be used as an aid in the diagnosis of Coeliac Disease. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. In addition to the manual assay protocol, this device has been validated for use with the HYCOR HY.TEC automated EIA instrument. For in vitro diagnostic use only.

Device Story

Device is semi-quantitative ELISA for detection of anti-tTg IgG antibodies in human serum; utilizes microplate wells coated with recombinant human tissue transglutaminase. Input: human serum samples. Process: patient serum added to antigen-coated wells; anti-tTg IgG binds to antigen; horseradish peroxidase-conjugated anti-human IgG added; TMB substrate added to produce colorimetric reaction proportional to antibody concentration. Output: optical density measured at 450nm via spectrophotometer; results calculated as arbitrary units/mL. Used in clinical laboratories; manual protocol or automated via HYCOR HY.TEC EIA instrument. Output aids clinicians in Celiac Disease diagnosis as part of multi-factorial diagnostic regime.

Clinical Evidence

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

Technological Characteristics

Solid-phase ELISA; 96-well microtiter plates coated with recombinant tissue transglutaminase (E. coli derived). Detection via horseradish peroxidase-conjugated anti-human IgG and TMB substrate. Energy source: spectrophotometer (450nm). Connectivity: standalone or integrated with HYCOR HY.TEC automated EIA instrument. Software: automated dilution and calculation functions.

Indications for Use

Indicated for use as an aid in the diagnosis of Celiac Disease in human patients. The device detects IgG autoantibodies to tissue transglutaminase (tTg) in serum.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird-like figure with three wing-like shapes.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 7 - 2005

Hycor Biomedical Ltd. c/o Ms. Danielle M. Knight Pentlands Science Park Bush Loan Penicuik EH26 OPL United Kingdom

Re: k043433

k043433
Trade/Device Name: AUTOSTAT™ II Anti-Tissue Transglutaminase IgG ELISA
Trade/Device Name: AUTOSTATTM II Regulation Number: 21 CFR 866.5660 Regulation Name: 21 OF Resolution immunological test system Regulatory Class: Class II Product Code: MVM Dated: December 7, 2004 Received: December 15, 2004

Dear Ms. Knight:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) premanted is substantially equivalent (for the indications for referenced above and nave actemined the are devices marketed in interstate commerce
use stated in the enclosure) to legally marketed predicants, or to devices that use stated in the enclosure) to tegally manited proadine and mondments, or to devices that pror to May 28, 1976, the enactinent date of the Federal Food. Of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the CPMA >> have been reclassified in accordance with the provisional application (PMA). You may,
Act (Act) that do not require approval of a premarket approval application (Act (The yo Act (Act) that do not require approval of a provisions of the Act . The general therefore, market the device, subject to the general registration, list in the destices, good controls provisions of the netide requiritions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in h If your device is classified (sec above) into enaler regulations affecting your device can be may be subject to such additions, Title 21, Parts 800 to 898. 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 Please be advised that FDA s Issualice of a substance of a subcures with other requirement of the Act or that FDA has made a decemination mar your as router Federal agencies. You must comply with (21) CED Port 807) any Federal Statules and regulations administered by two registration and listing (21 CFR Parts of the availity all ine Act s requirements, including, but no rise requirements as set forth in the quality
labeling (21 CFR Part 801); good manufacturing practice the since duat reading rea labeling (21 CFR Part 801), good manazati.net production the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product systems (QS) regulation (21-542 of the Act); 21 CFR 1000-1050.

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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 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), please contact the Office of Compliance 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,

Robert J. Backerh.

Robert L. Becker, Jr., M.D., PhD 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): K043433

Device Name: AUTOSTAT™ II Anti-Tissue Transglutaminase IgG ELISA

## Indications For Use:

Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to tissue transglutaminase (tTg) in human serum.

Uses:

The results of the anti-fTg assay can be used as an aid in the diagnosis of Coeliac Disease. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.

In addition to the manual assay protocol, this device has been validated for use with the HYCOR HY.TEC automated EIA instrument.

For in vitro diagnostic use only.

ﮮ

Prescription Use Yes No (Part 21 CFR 801 Subpart D) Over-The-Counter Use

(21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1

Mana M Chan

**Division Sign-Off**

Office of In Vitro Diagnosti Device Evaluation and SCIES

510(k) K043453