MININEPH HUMAN B2-MICROGLOBULIN KIT

K014270 · The Binding Site, Ltd. · JZG · Aug 15, 2002 · Immunology

Device Facts

• Record ID: K014270
• Device Name: MININEPH HUMAN B2-MICROGLOBULIN KIT
• Applicant: The Binding Site, Ltd.
• Product Code: JZG · Immunology
• Decision Date: Aug 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5630
• Device Class: Class 2

Indications for Use

This kit is designed for the in vitro measurement of human B2-Microglobulin in serum and urine using the Minineph, to aid in the diagnosis of active rheumatoid arthritis and kidney disease.

Device Story

The Minineph Human B2-Microglobulin Kit is an in vitro diagnostic assay used with the Minineph analyzer. It measures B2-Microglobulin concentrations in human serum and urine samples. The device utilizes immunological principles to quantify the analyte, providing results that assist clinicians in diagnosing active rheumatoid arthritis and kidney disease. It is intended for professional use in clinical laboratory settings.

Clinical Evidence

No clinical data provided; substantial equivalence is based on the device's intended use and technological characteristics as an immunological test system.

Technological Characteristics

Immunological test system for B2-Microglobulin measurement. Designed for use with the Minineph analyzer. In vitro diagnostic device.

Indications for Use

Indicated for in vitro measurement of human B2-Microglobulin in serum and urine to aid in the diagnosis of active rheumatoid arthritis and kidney disease.

Regulatory Classification

Identification

A beta-2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques beta-2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement of beta-2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

Submission Summary (Full Text)

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

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## AUG 1 5 2002

k014270 Re:

> Trade/Device Name: MININEPH® Human Beta-2 Microglobulin Kit Regulation Number: 21 CFR § 866.5630 Regulation Name: Beta-2 Microglobulin Immunological Test System Regulatory Class: II Product Code: JZG, JZW Dated: August 6, 2002 Received: August 8, 2002

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 Jegally 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 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,

Steven Autman

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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## INDICATIONS FOR USE STATEMENT

Minineph Human B2 Microglobulin Kit Device Name:

Indications for Use: This kit is designed for the in vitro measurement of human B2-Microglobulin in serum and urine using the Minineph, to aid in the diagnosis of active rheumatoid arthritis and kidney disease.

Sousan, Alta.e

(Division Sign-Off) (Division of Clinical Laboratory Devices

510(k) Number K014270

Prescription Use ✓
(Per 21 CFR 801.109)

ATTACHMENT >

K014270