MININEPH HUMAN RHEUMATOID FACTOR KIT

K041891 · The Binding Site · DHR · Nov 5, 2004 · Immunology

Device Facts

• Record ID: K041891
• Device Name: MININEPH HUMAN RHEUMATOID FACTOR KIT
• Applicant: The Binding Site
• Product Code: DHR · Immunology
• Decision Date: Nov 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5775
• Device Class: Class 2

Intended Use

This kit is designed for the in vitro measurement of human Rheumatoid Factor in serum using MININEPH™. Measurement of Rheumatoid Factor may aid in the diagnosis of rheumatoid arthritis.

Device Story

Minineph Human Rheumatoid Factor Kit is an in vitro diagnostic test system. It measures human Rheumatoid Factor levels to assist clinicians in diagnosing rheumatoid arthritis. The device is intended for professional use in clinical laboratory settings. It functions as an immunological test system.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Latex-enhanced nephelometry; polystyrene microparticles coated with aggregated human IgG; quantitative measurement via photodiode light scattering detection; lot-specific magnetic swipe card calibration; serum matrix; requires MININEPH™ Instrument.

Indications for Use

Indicated for the in vitro measurement of human Rheumatoid Factor to aid in the diagnosis of rheumatoid arthritis.

Regulatory Classification

Identification

A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing right, stacked on top of each other, with flowing lines beneath them.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

NOV - 5 2004

Re: k041891

> Trade/Device Name: Minineph Human Rheumatoid Factor Kit Regulation Number: 21 CFR § 866.5775 Regulation Name: Rheumatoid Factor Immunological Test System Regulatory Class: II Product Code: DHR Dated: October 6, 2004 Received: October 13, 2004

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,

Robert L. Becker Jr.

Robert L. Becker, Jr., M.D., Ph.D., Ph. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K041891

Device Name: Minineph Human Rheumatoid Factor Kit

Indications for Use: This kit is designed for the In Vitro measurement of human mulcations for 050. This in to assigned in NINEPH. Measurement of Rheumatoid Factor may aid in the diagnosis of rheumatoid arthritis.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chan

Division Sign-Off

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Office of In Vitro Diage stoc Device Evaluation and in

510(k) K041891