MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS

K981209 · The Binding Site, Ltd. · MVM · Oct 22, 1998 · Immunology

Device Facts

• Record ID: K981209
• Device Name: MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS
• Applicant: The Binding Site, Ltd.
• Product Code: MVM · Immunology
• Decision Date: Oct 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

This kit is intended for screening of antibodies to intra-epidermal antigens or basement membrane zones in human serum as an aid in the diagnosis of pemphigus and bullous pemphigoid respectively. It can also be used for screening of endomysial antibodies as an aid in the diagnosis of celiac disease.

Device Story

Monkey Oesophagus IFA Kit is an in vitro diagnostic test; utilizes indirect immunofluorescence (IFA) methodology. Input: human serum samples. Process: serum incubated with monkey oesophagus tissue substrate; specific antibodies bind to tissue antigens; secondary fluorescent-labeled anti-human immunoglobulin added; visualization via fluorescence microscopy. Output: qualitative detection of antibodies. Used in clinical laboratory settings by trained laboratory personnel. Results assist clinicians in diagnosing pemphigus, bullous pemphigoid, and celiac disease. Provides diagnostic aid to support clinical evaluation.

Clinical Evidence

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

Technological Characteristics

Indirect immunofluorescence (IFA) assay; utilizes monkey oesophagus tissue substrate as the antigen source; requires fluorescence microscopy for visualization; in vitro diagnostic kit format.

Indications for Use

Indicated for screening human serum for antibodies to intra-epidermal antigens (aid in pemphigus diagnosis), basement membrane zones (aid in bullous pemphigoid diagnosis), and endomysial antibodies (aid in celiac disease diagnosis).

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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## OCT 2 2 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

The Binding Site, Limited C/O Mr. Jay H. Geller East Tower, Suite 600 2425 West Olympic Boulevard Santa Monica, California 90404

K981209/S1 Re : Monkey Oesophagus IFA Kit Trade Name: Regulatory Class: II Product Code: MVM Dated: August 4, 1998 Received: August 11, 1998

Dear Mr. Geller:

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 Requlations, 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"(21 CFR 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): K981209 Oesophagus IFA Kit Device Name:

## INDICATIONS FOR USE STATEMENT

Monkey Oesophagus IFA Kit Device Name:

This kit is intended for screening of Indications for Use: antibodies to intra-epidermal antigens or basement membrane zones in human serum as an aid in the diagnosis of pemphigus and bullous pemphigoid respectively. It can also be used for screening of endomysial antibodies 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 G. Maurer

Laboratory Devices

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)