BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT

K991802 · The Binding Site, Ltd. · MSV · May 5, 2000 · Immunology

Device Facts

• Record ID: K991802
• Device Name: BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT
• Applicant: The Binding Site, Ltd.
• Product Code: MSV · Immunology
• Decision Date: May 5, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

For the in-vitro measurement of IgA autoantibodies against B2-glycoprotein 1 (B2GP1) present in human serum. This kit may be used in conjunction with anticardiolipin assays and clinical information to aid the diagnosis of thrombosis in at risk patients having, for example, antiphospholipid syndrome (APS) or systemic lupus erythematosus (SLE).

Device Story

Bindazyme Anti-B2 GP1 IgA EIA Test Kit is an in-vitro diagnostic assay. It measures IgA autoantibodies against B2-glycoprotein 1 in human serum samples. The device utilizes an enzyme immunoassay (EIA) principle. It is intended for use in clinical laboratory settings by trained laboratory personnel. Results are interpreted by clinicians in conjunction with anticardiolipin assays and other clinical information to assist in diagnosing thrombosis in patients with conditions like APS or SLE. The test provides quantitative or semi-quantitative data to support clinical decision-making regarding thrombotic risk.

Clinical Evidence

No clinical data provided in the document; the document is a 510(k) clearance letter.

Technological Characteristics

Enzyme immunoassay (EIA) test kit for the detection of IgA autoantibodies. The device is an in-vitro diagnostic reagent system. No specific materials, software, or connectivity features are described.

Indications for Use

Indicated for in-vitro measurement of IgA autoantibodies against B2-glycoprotein 1 (B2GP1) in human serum to aid in the diagnosis of thrombosis in patients at risk, such as those with antiphospholipid syndrome (APS) or systemic lupus erythematosus (SLE).

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 is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of three wavy lines above three smaller wavy lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

**MAY - 5 2000**

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

Re: K991802 Trade Name: Bindazyme® Anti-B2 GP1 IgA EIA Test Kit Regulatory Class: II Product Code: MSV Dated: March 31, 2000 Received: April 4, 2000

## 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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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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Page_ |_of_

510(k) Number (if known): _ | 99 / 807-

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

## INDICATIONS FOR USE STATEMENT

Bindazyme® Anti-B2 GP1 IgA EIA Test Kit Device Name:

for ' Use: For the in-vitro measurement of IgA Indications autoantibodies against B2-glycoprotein 1 (B2GP1) present in human This kit may be used in conjunction with anticardiolipin serum. assays and clinical information to aid the diagnosis of thrombosis in at risk patients having, for example, antiphospholipid syndrome (APS) or systemic lupus erythematosus (SLE) .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

tute E. Maleni

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991802

Prescription Use √
(Per 21 CFR 801.109)

OR

一,

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)