BINDAZYME CLQ CIC EIA KIT

K031563 · The Binding Site, Ltd. · DAK · Sep 10, 2003 · Immunology

Device Facts

• Record ID: K031563
• Device Name: BINDAZYME CLQ CIC EIA KIT
• Applicant: The Binding Site, Ltd.
• Product Code: DAK · Immunology
• Decision Date: Sep 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5240
• Device Class: Class 2

Intended Use

This assay is designed for the in-vitro measurement of circulating immune complexes (CIC) that bind Clq, measurement on on serum. It is intended for the determination of presence in names patients with various autoimmune and other CICrelated disease, and is used in conjunction with other clinical findings.

Device Story

The BINDAZYME C1q Binding Circulating Immune Complex Enzyme Immunoassay Kit is an in-vitro diagnostic test used to detect circulating immune complexes (CIC) in human serum. The device utilizes an enzyme immunoassay (EIA) principle to measure the presence of CICs that bind to C1q. It is intended for use in clinical laboratory settings by trained laboratory personnel. The output is a measurement of CIC levels, which healthcare providers use alongside other clinical findings to assist in the diagnosis and management of autoimmune and other CIC-related conditions. The test provides quantitative or semi-quantitative data to support clinical decision-making regarding patient immune status.

Clinical Evidence

Bench testing only. Analytical performance included intra-assay (CV 5.5-7.5%) and inter-assay (CV 3.9-13.0%) precision. Linearity demonstrated with R² > 0.99. Limit of detection is 0.1 µg Eq/mL. Method comparison with predicate (n=48) showed 83.3% agreement and R²=0.8082. Normal range established using 200 healthy donors.

Technological Characteristics

Enzyme immunoassay; microtiter plate solid phase coated with human C1q; peroxidase-labeled rabbit anti-human IgG conjugate; TMB substrate; 3M phosphoric acid stop solution. Measures absorbance at 450 nm. Semi-quantitative; results calculated against aggregated human IgG calibrators.

Indications for Use

Indicated for the in vitro measurement of circulating immune complexes (CIC) that bind C1q in human serum for patients with autoimmune or other CIC-related diseases. For prescription use only.

Regulatory Classification

Identification

A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 0 2003

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

Re: k031563

> Trade/Device Name: BINDAZYME C1q Binding Circulating Immune Complex Enzyme Immunoassay Kit Regulation Number: 21 CFR § 866.5240 Regulation Name: Complement Components Immunological Test System Regulatory Class: II Product Code: DAK Dated: July 28, 2003 Received: July 31, 2003

Dear Mr. Geller:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) 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 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.

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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" (21CFR Part 807.97). 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/dsma/dsmamain.html.

Sincerely yours,

ﺮ ﺍﻟﻤﺮﺍﺟﻊ

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K031563

## INDICATIONS FOR USE STATEMENT

BINDAZYME Clq Binding Circulating Immune Complex Device Name: Enzyme Immunoassay Kit

Indications for Use: This assay is designed for the in-vitro measurement of circulating immune complexes (CIC) that bind Clq, measurement on on serum. It is intended for the determination of presence in names patients with various autoimmune and other CICrelated disease, and is used in conjunction with other clinical findings.

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**Division Sign-Off**

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) <031563

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