K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET

K991467 · Kamiya Biomedical Co. · DHR · Jun 10, 1999 · Immunology

Device Facts

• Record ID: K991467
• Device Name: K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET
• Applicant: Kamiya Biomedical Co.
• Product Code: DHR · Immunology
• Decision Date: Jun 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5775
• Device Class: Class 2

Intended Use

The K-ASSAY RF Calibrator Set is intended to be used for the calibration of the K-ASSAY RF immunoturbidimetric assay for quantitating Rheumatoid Factor in serum samples.

Device Story

K-ASSAY RF Calibrator Set is an in vitro diagnostic product used to calibrate the K-ASSAY RF immunoturbidimetric assay. The calibrator is used by laboratory professionals in clinical settings to establish a reference curve for the quantitative measurement of Rheumatoid Factor in patient serum samples. By providing known concentrations of Rheumatoid Factor, the calibrator enables the assay to accurately determine the concentration of the analyte in unknown patient samples, aiding in the clinical assessment of rheumatoid arthritis and related conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic calibrator set for immunoturbidimetric assays. Formulated for use with K-ASSAY RF assay. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for the calibration of the K-ASSAY RF immunoturbidimetric assay to quantitate Rheumatoid Factor in human serum samples. For professional use only.

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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## JUN 10 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Colin Getty Official Correspondent Kamiya Biomedical Company 910 Industry Drive Seattle, Washington 98188

> K991467 Trade Name: K-ASSAY Rheumatoid Factor Calibrator Set Regulatory Class: II Product Code: DHR Dated: April 21, 1999 Received: April 27, 1999

Dear Mr. Getty:

Re:

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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## Page 2

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 Butman

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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

K-ASSAY RF Calibrator Set. Device Name:

Indications For Use:

The K-ASSAY RF Calibrator Set is intended to be used for the calibration of the K-ASSAY RF immunoturbidimetric assay for quantitating Rheumatoid Factor in serum samples.

(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 | K991467 |
| 510(k) Number | |

| Prescription Use | <img alt="Prescription Check" src="prescription_check.png"/> | OR | Over-The-Counter Use | |
|----------------------|--------------------------------------------------------------|----|----------------------|-------------------------|
| (Per 21 CFR 801.109) | | | | Optional Format 1-2-96) |

RF Calibrator 510(k)

4/21/99