EU-TTG IGA ELISA

K994379 · Scimedx Corp. · MVM · Feb 18, 2000 · Immunology

Device Facts

• Record ID: K994379
• Device Name: EU-TTG IGA ELISA
• Applicant: Scimedx Corp.
• Product Code: MVM · Immunology
• Decision Date: Feb 18, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

Eu-tTG®IgA assay is a qualitative ELISA test for the in vitro diagnostic detection of IgA antibody against the enzyme tissue Transglutaminase in human serum. This test is designed for use as an aid in the diagnosis of Celiac Disease.

Device Story

Eu-tTG® IgA Assay is an enzyme-linked immunosorbent assay (ELISA) kit. It detects IgA antibodies against tissue transglutaminase in human serum samples. The device is intended for use in clinical laboratory settings by trained laboratory personnel. The assay provides qualitative results to assist clinicians in the diagnosis of Celiac Disease. It functions as an in vitro diagnostic tool; results are interpreted by healthcare providers in conjunction with clinical symptoms and other diagnostic findings to support patient management decisions.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) kit for qualitative detection of IgA antibodies. In vitro diagnostic device. Standard laboratory immunoassay format.

Indications for Use

Indicated for the qualitative in vitro diagnostic detection of IgA antibodies against tissue transglutaminase in human serum as an aid in the diagnosis of 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)

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FEB 1 8 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Eurospital S.p.A. c/o Gary Lehnus, Ph.D. Scimedx Corporation 400 Ford Road Denville, New Jersey 07834

Re: K994379 Trade Name: Eu-tTG® IgA Assay Regulatory Class: II Product Code: MVM Dated: December 22, 1999 Received: December 27, 1999

Dear Dr. Lehnus:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Eu-tTG®IgA Assay_

Enzyme Immunoassay Kit

## Indications For Use:

Eu-tTG®IgA assay is a qualitative ELISA test for the in vitro diagnostic detection of IgA antibody against the enzyme tissue Transglutaminase in human serum. This test is designed for use as an aid in the diagnosis of Celiac Disease.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Malin

(Division Sign-Off)
Division of Clinical Laboratory Devices K994379
510(k) Number

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)