BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT

K984619 · The Binding Site, Ltd. · MVJ · Feb 23, 1999 · Immunology

Device Facts

• Record ID: K984619
• Device Name: BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT
• Applicant: The Binding Site, Ltd.
• Product Code: MVJ · Immunology
• Decision Date: Feb 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

For the in-vitro measurement of specific IgG autoantibodies against the glomerular basement membrane (GBM) specifically the C-terminal end of type IV collagen, present in human serum. It is intended as an aid in the diagnosis of Goodpasture's syndrome, in conjunction with other clinical findings.

Device Story

The BINDAZYME Anti-GBM EIA is an enzyme immunoassay diagnostic test kit. It processes human serum samples to detect IgG autoantibodies targeting the C-terminal end of type IV collagen (glomerular basement membrane). The device is used in clinical laboratory settings by trained laboratory personnel. The assay provides quantitative or qualitative results that assist clinicians in diagnosing Goodpasture's syndrome. Results are interpreted alongside other clinical findings to support diagnostic decision-making, potentially facilitating earlier identification and management of the condition.

Technological Characteristics

Enzyme immunoassay (EIA) diagnostic test kit for the detection of IgG autoantibodies. The device utilizes an antigen-specific binding mechanism to identify antibodies against the C-terminal end of type IV collagen.

Indications for Use

Indicated for the in-vitro measurement of IgG autoantibodies against the C-terminal end of type IV collagen in human serum to aid in the diagnosis of Goodpasture's syndrome in patients presenting with relevant clinical symptoms.

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 2 3 1999

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

Re: K984619

Trade Name: Binding Site BINDAZYME® Anti-GBM Enzyme Immunoassay Diagnostic Test Kit

Regulatory Class: II Product Code: MVJ Dated: December 23, 1998 Received: December 29, 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 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 Putman.

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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Page__________________________________________________________________________________________________________________________________________________________________________

| 10(k) Number (if known): | K984419 |
|--------------------------|-----------|
| Device Name: | BINDAZYME |

Anti-GBM EIA Diagnostic Test Kit## Indications For Use:

## INDICATIONS FOR USE STATEMENT

Anti-GBM EIA Diagnostic Test Kit Device Name:

For the in-vitro measurement of specific IgG Indications for Use: autoantibodies against the glomerular basement membrane (GBM) specifically the C-terminal end of type IV collagen, present in It is intended as an aid in the diagnosis of human serum. in conjunction with other clinical syndrome, Goodpasture's findings.

Voter E. Maples

(Division Sign Off) Division of Jimear Laboratury Leve & 984619 510(k) NumiDer _______________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use b (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)