BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS

K040466 · The Binding Site · MVM · Jul 16, 2004 · Immunology

Device Facts

• Record ID: K040466
• Device Name: BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS
• Applicant: The Binding Site
• Product Code: MVM · Immunology
• Decision Date: Jul 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

This assay is designed for the in-vitro measurement of specific IgG autoantibodies against tissue transglutaminase (tTG) present in human serum, as an aid in the diagnosis of Coeliac disease. This assay is designed for the in-vitro measurement of specific IgA autoantibodies against tissue transglutaminase (tTG) present in human serum, as an aid in the diagnosis of Coeliac disease.

Device Story

Enzyme immunoassay (EIA) kits for detection of IgA or IgG autoantibodies against tissue transglutaminase (tTG) in human serum; aid in diagnosis of Coeliac Disease. Device uses microtiter plates coated with recombinant human tTG antigen. Patient serum samples, calibrators, and controls added to wells; autoantibodies bind to tTG. After washing, peroxidase-labeled rabbit anti-human IgA or IgG conjugate added; binds to captured autoantibodies. TMB substrate added to produce blue color, followed by phosphoric acid to stop reaction, resulting in yellow endpoint color. Optical density measured at 450nm using plate reader. Intensity proportional to autoantibody concentration. Used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing Coeliac Disease.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on bench testing and performance characteristics typical of enzyme immunoassay diagnostic kits.

Technological Characteristics

Enzyme immunoassay (EIA) using recombinant human tTG antigen-coated microtiter plates. Detection via peroxidase-labeled rabbit anti-human IgA or IgG conjugate and TMB substrate. Requires plate reader (450nm). Semi-quantitative measurement reported in arbitrary units. No specific material standards cited.

Indications for Use

Indicated for the in-vitro measurement of specific IgG or IgA autoantibodies against tissue transglutaminase (tTG) in human serum as an aid in the diagnosis of Coeliac disease. 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).

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 is a circular seal with 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 overlap each other.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

The Binding Site c/o Mr. Jay H. Geller West Tower, Suite 4000 2425 West Olympic Blvd Santa Monica, CA 90404

JUL 16 2004

Re: k040466

Trade/Device Name: Bindazyme® Human IgG Anti-Tissue Transglutaminase Enzyme Immunoassay Kit Bindazyme® Human IgA Anti-Tissue Transglutaminase Enzyme Immunoassay Kit Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MVM Dated: June 15, 2004 Received: June 17, 2004

Dear Mr. Geller:

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 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.

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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,

Robert L. Becker Jr.

Robert L. Becker, Jr., M.D., Ph. 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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Bindazyme® Human IgG Anti-Tissue Transglutaminase Device Name: Enzyme Immunoassay Kit

This assay is designed for the in-vitro Indications for Use: of specific IgG autoantibodies aqainst tissue measurement transglutaminase (tTG) present in human serum, as an aid in the diagnosis of Coeliac disease.

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OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mana Chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040466

Prescription Use_ / (Per 21 CFR 801.109) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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Bindazyme® Human IgA Anti-Tissue Transglutaminase Device Name: Enzyme Immunoassay Kit

This assay is designed for the in-vitro Indications for Use: measurement of specific IqA autoantibodies against tissue transglutaminase (tTG) present in human serum, as an aid in the diagnosis of Coeliac disease.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mara Chan

Division Sign-Off

Office of In Vitro Dlagnostic Device Evaluation and Safety

510(K) KO40466

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Prescription Use / (Per 21 CFR 801-109) OR

(Optional Format 1-2-96)