LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS

K983130 · Kamiya Biomedical Co. · JJY · Sep 29, 1998 · Clinical Chemistry

Device Facts

• Record ID: K983130
• Device Name: LIQUID IMMUNOLOGY 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 immunoturbidimetric assays for the listed constituents.

Device Story

The KAMIYA Immunology Control is a liquid-stable, human serum-based, assayed control. It serves as a reference sample with known concentrations to monitor the performance and precision of immunoturbidimetric assays. The product is provided in two levels and is manufactured from human serum tested negative for HBsAg, anti-HCV, and anti-HIV. Assigned values are traceable to the CAP/BCR/IFCC Reference Preparation for Proteins in Human Serum. It is intended for use by laboratory professionals to ensure assay accuracy and consistency. By comparing test results against the known control values, clinicians can verify the reliability of patient sample analysis, thereby supporting accurate clinical decision-making.

Clinical Evidence

Bench testing only. Performance was evaluated by comparing within-run and between-day precision and reaction characteristics for 10 analytes against the predicate device.

Technological Characteristics

Liquid-stable, human serum-based control. Traceable to CAP/BCR/IFCC Reference Preparation for Proteins in Human Serum. Stability: 1 year unopened, 1 month opened. No software or electronic components.

Indications for Use

Indicated for use as a consistent test sample of known concentration for monitoring the performance of immunoturbidimetric assays for listed constituents 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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Kg8-3130

## 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.

K983130 The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

September 2, 1998 Date:

- Colin Getty Submitted by: KAMIYA BIOMEDICAL COMPANY 910 Industry Drive. Seattle WA 98188 TEL: [phone]; FAX: [phone]
Product: Immunology Control

The KAMIYA Immunology Control is a liquid-stable, human serum-based, assayed control for use as a consistent test sample of known concentration for monitoring the performance of immunoturbidimetric assays for the listed constituents.

Two levels of the KAMIYA Immunology Control are provided. The human serum used to manufacture this product is tested and found negative for the presence of HBsAg and antibody to CV and HIV. The assigned values are traceable to the CAP/BCR/IFCC Reference Preparation for Proteins in Human Serum. The product is stable for at least 1 year (unopened) and 1 month (after opening).

The safety and effectiveness of the KAMIYA Immunology Control is demonstrated by its substantial equivalence to the Sigma Immunology Control (K851202) manufactured by Gilford. The KAMIYA Immunology Control shows similar within run and between day precision and reaction characteristics for the 10 analytes tested.

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## 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 : K983130 Trade Name: Immunology Control Regulatory Class: I Product Code: JJY Dated: September 4, 1998 Received: September 8, 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, 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 Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 labelinq 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

983130 510(k) Number (if known):

Device Name: Immunology Controls

Indications For Use:

As a consistent test sample of known concentration for monitoring the performance of immunoturbidimetric assays for the listed constituents.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Martin

Division Sign-Off Division of Clinical Laborator 510(k) Number

Prescription Use
(Per 21 CFR 801.109) V

OR

Over-The-Counter Use

Optional Format 1-2-96)

Liquid Immunology Control