BINDAZYME ANTI-DSDNA EIA KIT

K993727 · The Binding Site, Ltd. · LRM · Dec 21, 1999 · Immunology

Device Facts

• Record ID: K993727
• Device Name: BINDAZYME ANTI-DSDNA EIA KIT
• Applicant: The Binding Site, Ltd.
• Product Code: LRM · Immunology
• Decision Date: Dec 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

This assay is intended for the in-vitro measurement of specific IgG autoantibodies against double stranded deoxyribonucleic acid (dsDNA) present in human serum, as an aid to the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other clinical findings.

Device Story

BINDAZYME Anti-dsDNA EIA is an in-vitro diagnostic test kit; measures IgG autoantibodies against double-stranded DNA (dsDNA) in human serum samples. Used in clinical laboratory settings to aid diagnosis of systemic lupus erythematosus (SLE). Operates via enzyme immunoassay (EIA) principle; results interpreted by clinicians alongside other clinical findings to support SLE diagnosis. Provides quantitative or semi-quantitative assessment of autoantibody levels.

Clinical Evidence

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

Technological Characteristics

Enzyme immunoassay (EIA) for detection of IgG autoantibodies. In-vitro diagnostic test kit format. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for the in-vitro measurement of IgG autoantibodies against dsDNA in human serum to aid in the diagnosis of systemic lupus erythematosus (SLE) in conjunction with other clinical findings.

Regulatory Classification

Identification

An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

Submission Summary (Full Text)

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## Public Health Service

## DEC 2 1 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K993727 Trade Name: BINDAZYME Anti-dsDNA EIA Regulatory Class: II Product Code: LRM Dated: October 21, 1999 Received: October 25, 1999

## 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 Sutman

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): | K993727 |
|---------------------------|----------------------|
| Device Name: | Bindazyme Anti-dsDNA |

Indications For Use:

BINDAZYME® Anti-dsDNA EIA Test Kit Device Name:

This assay is intended for the in-vitro Indications for Use: measurement of specific IgG autoantibodies against double stranded deoxyribonucleic acid (dsDNA) present in human serum, as an aid to the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other clinical findings.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

*Site Machin*

(Division Sign-O10
Division of Clinieel Laboratory Devices K993727
510MM

Prescription Use_ (Pcr 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)