THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS

K071692 · Theratest Laboratories, Inc. · MVM · Nov 5, 2007 · Immunology

Device Facts

• Record ID: K071692
• Device Name: THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS
• Applicant: Theratest Laboratories, Inc.
• Product Code: MVM · Immunology
• Decision Date: Nov 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The TheraTest EL-tTG™ IgA/IgG and TheraTest EL-GLIA™ IgA/IgG Kits are enzyme-linked immunosorbent assay (ELISA) test systems for the semi-quantitative measurement of IgA and IgG anti-tissue transglutaminase (tTG) and anti-gliadin antibodies in human serum. Detection and semi-quantitation of these antibodies is intended to aid the diagnosis of patients with gluten sensitive enteropathies: celiac disease and dermatitis herpetiformis, in conjunction with other clinical findings and laboratory tests.

Device Story

ELISA-based test system for semi-quantitative measurement of IgA and IgG antibodies against tissue transglutaminase (tTG) or gliadin in human serum; utilizes 96-well microtiter plates coated with recombinant human tTG or purified gliadin; patient serum samples incubated in wells; anti-tTG or anti-gliadin antibodies bind to solid-phase antigen; unbound material washed away; isotype-specific horseradish-peroxidase labeled anti-human immunoglobulin conjugate added; chromogenic substrate (TMB) added; color intensity proportional to bound antibody concentration measured via spectrophotometer at 450 nm; used in clinical laboratory settings by trained personnel; results aid diagnosis of celiac disease and dermatitis herpetiformis in conjunction with other clinical findings.

Clinical Evidence

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

Technological Characteristics

Solid-phase ELISA; 96-well microtiter plates coated with recombinant human tTG or purified gliadin; colorimetric detection using horseradish-peroxidase conjugate and TMB substrate; requires spectrophotometer (450 nm); semi-quantitative output in arbitrary units; manual or automated wash steps.

Indications for Use

Indicated for patients suspected of having gluten-sensitive enteropathies, specifically celiac disease and dermatitis herpetiformis. Used as an aid in diagnosis in conjunction with other clinical and laboratory findings.

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}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around it. The eagle is positioned to the right of the text, creating a balanced and recognizable symbol for the department.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV - 5 2007

TheraTest Laboratories, Inc. c/o Marius Teodorescu, MD, PhD President and CEO 1111 North Main Street Lombard, IL 60148

Re: k071692

Trade/Device Name: EL-tTGTM IgA/IgG and EL-Glia™ IgA/IgG Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MVM, MST Dated: October 01, 2007 Received: October 02, 2007

Dear Dr. Teodorescu:

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 the Code of Federal Regulations, 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 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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

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

Page 2 -

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 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Robert Becker

Robert L. Becker, Jr., M.D., 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

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

## Attachment 2

## Indications for Use Statement

TheraTest EL-tTGTM IgA/IgG and TheraTest EL-Glia™ IgA/IgG

510(k)Number 071692

TheraTest EL-tTGTM IgA/IgG Device Name:

TheraTest EL-Glia™ IgA/IgG

Indications for Use. The TheraTest EL-tTG™ IgA/IgG and TheraTest EL-GLIATM IgA/IgG Kits are enzyme-linked immunosorbent assay (ELISA) test systems for the semi-quantitative measurement of IgA and IgG anti-tissue transglutaminase (tTG) and anti-gliadin antibodies in human serum. Detection and semi-quantitation of these antibodies is intended to aid the diagnosis of patients with gluten sensitive enteropathies: celiac disease and dermatitis herpetiformis, in conjunction with other clinical findings and laboratory tests.

m Chan
Division Sign-Off

Office of in Vitro Diagnostic Device Evaluation and Safety

071692 510(k) --

Prescription use X = = =

AND/OR

Over-the-counter use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of in vitro Diagnostic devices (OIVD)