ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS

K983241 · Kamiya Biomedical Co. · JJY · Sep 29, 1998 · Clinical Chemistry

Device Facts

• Record ID: K983241
• Device Name: ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS
• Applicant: Kamiya Biomedical Co.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Sep 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

As a consistent test sample of known concentration for monitoring the performance of ASO, CRP, and RF immunoturbidimetric assays.

Device Story

KAMIYA ASO/CRP/RF Control is a lyophilized, human serum-based, assayed control; used to monitor performance of ASO, CRP, and RF immunoturbidimetric assays. Product provided in two levels; human serum tested negative for HBsAg, anti-HCV, and anti-HIV. Assigned values are traceable to international reference preparations (CAP/BCR/IFCC for CRP; WHO for RF; Japanese National Standard for ASO). Used by laboratory technicians to verify assay precision and reaction characteristics. Stability: 1 year unopened, 2 weeks post-reconstitution.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated via bench testing comparing precision and reaction characteristics of the subject device against the predicate device.

Technological Characteristics

Lyophilized human serum-based control; assayed for ASO, CRP, and RF. Traceable to international reference standards. Stability: 1 year unopened, 2 weeks reconstituted. No electronic components or software.

Indications for Use

Indicated for use as a consistent test sample of known concentration for monitoring the performance of ASO, CRP, and RF immunoturbidimetric assays in clinical laboratory settings.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Sigma Immunology Control (K851202)

Submission Summary (Full Text)

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KC983241/

# KAMIYA BIOMEDICAL COMPANY

910 Industry Drive, Seattle, WA 98188 USA

TEL: [phone] FAX:[phone]

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

K 983241 The assigned 510(k) number is: ______________________________________________________________________________________________________________________________________________

September 10, 1998 Date:

- Submitted by: Colin Getty KAMIYA BIOMEDICAL COMPANY 910 Industry Drive, Seattle WA 98188 TEL: [phone]; FAX: [phone]
ASO/CRP/RF Control Product:

The KAMIYA ASO/CRP/RF Control is a lyophilized, human serum-based, assayed control for use as a consistent test sample of known concentration for monitoring the performance of ASO, CRP, and RF immunoturbidimetric assays.

Two levels of the KAMIYA ASO/CRP/RF Control are provided. The human serum used to manufacture this product is tested and found negative for the presence of HBsAg and antibody to HCV and HIV. The assigned CRP values are traceable to the CAP/BCR/IFCC Reference Preparation for Proteins in Human Serum. The assigned RF values are traceable to the WHO International Reference Preparation of Rheumatoid Arthritis Serum. The assigned ASO values are traceable to the Japanese National Standard for ASO.

This product is stable for at least 1 year (unopened) and 2 weeks (after reconstitution).

The safety and effectiveness of the KAMIYA ASO/CRP/RF Control is demonstrated by its substantial equivalence to the Sigma Immunology Control (K851202). The KAMIYA ASO/CRP/RF Control shows similar within run and between day precision and reaction characteristics for the 3 analytes.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and tail. The eagle is oriented diagonally in the frame. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.

## SEP 2 9 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re : K983241 Trade Name: ASO/CRP/RF Control Regulatory Class: I Product Code: JJY Dated: September 9, 1998 Received: September 15, 1998

Dear Mr.Getty:

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, Druq, 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 Requlations, 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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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 leqally 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 requlation 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 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

1983241 510(k) Number (if known): _____

Device Name: ASO/CRP/RF Controls

## Indications For Use:

As a consistent test sample of known concentration for monitoring the performance of ASO, CRP, and RF immunoturbidimetric assays.

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Concurrence of CDRH, Office of Device Evaluation (ODE)