B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM

K991136 · Olympus America, Inc. · JZG · May 11, 1999 · Immunology

Device Facts

• Record ID: K991136
• Device Name: B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM
• Applicant: Olympus America, Inc.
• Product Code: JZG · Immunology
• Decision Date: May 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5630
• Device Class: Class 2

Intended Use

The Olympus Beta-2-Microglobulin reagent is intended for use on Olympus Clinical Chemistry Analzyers for the quantitative determination of Beta-2-Microglobulin in human serum. Measurements of the amount of Beta-2-Microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

Device Story

Olympus Beta-2-Microglobulin is an in vitro diagnostic reagent for use on Olympus Clinical Chemistry Analyzers. It measures Beta-2-Microglobulin levels in human serum samples. The device is intended for professional use in clinical laboratory settings. Results assist clinicians in diagnosing active rheumatoid arthritis and kidney disease. The system automates the quantitative analysis of the target protein, providing data that informs clinical decision-making regarding renal function and inflammatory status.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on regulatory review of the device's intended use and performance characteristics as an in vitro diagnostic reagent.

Technological Characteristics

In vitro diagnostic reagent for quantitative determination of Beta-2-Microglobulin. Designed for use on Olympus Clinical Chemistry Analyzers. Operates via standard clinical chemistry assay principles for protein quantification in serum.

Indications for Use

Indicated for the quantitative determination of Beta-2-Microglobulin in human serum 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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## MAY 1 1 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive Melville, New York 11747-3157

K991136 Re: Trade Name: Olympus Beta-2-Microglobulin Regulatory Class: II Product Code: JZG Dated: April 1, 1999 Received: April 5, 1999

Dear Ms. Storms-Tyler:

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 Dutman

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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516 844 5275 P.04

Page 1 of 1

510(k) Number (if known): K991136

Device Name: Olympus Beta-2-Microglobulin

Indications For Use:

The Olympus Beta-2-Microglobulin reagent is intended for use on Olympus Clinical Chemistry Analzyers for the quantitative determination of Beta-2-Microglobulin in human serum.

Measurements of the amount of Beta-2-Microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K991136 |

| Prescription Use <span style="text-decoration: underline;">✓</span> (Per 21 CFR 801.109) | OR Over-The-Counter Use |
|------------------------------------------------------------------------------------------|--------------------------|
| | (Optional Format 1-2-96) |