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).

AI/ML Overview

The provided text describes the Kamiya ASO/CRP/RF Control, a lyophilized human serum-based control product used to monitor the performance of ASO, CRP, and RF immunoturbidimetric assays. The document is a 510(k) summary, which indicates that the device has been cleared by the FDA based on its substantial equivalence to a legally marketed predicate device.

1. Table of acceptance criteria and the reported device performance:

The document states that the safety and effectiveness of the KAMIYA ASO/CRP/RF Control is demonstrated by its substantial equivalence to the Sigma Immunology Control (K851202).

Acceptance Criteria Category	Specific Criteria/Measurement	Reported Device Performance (KAMIYA ASO/CRP/RF Control)
Substantial Equivalence	Equivalence to predicate device Sigma Immunology Control (K851202)	Demonstrated
Precision	Similar within-run precision	Achieved
Precision	Similar between-day precision	Achieved
Reaction Characteristics	Similar reaction characteristics for ASO, CRP, and RF analytes	Achieved

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample size used for the test set. It mentions "within run and between day precision," implying that multiple measurements were taken over different runs and days, but the number of samples or runs is not quantified. The data provenance is not specified (e.g., country of origin). The study appears to be a prospective validation conducted by the manufacturer to demonstrate equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to this type of device. The ground truth for this control product is its assigned values, which are traceable to specific international or national reference materials (CAP/BCR/IFCC Reference Preparation for Proteins in Human Serum for CRP, WHO International Reference Preparation of Rheumatoid Arthritis Serum for RF, and Japanese National Standard for ASO for ASO). These are not established by human experts in the context of image or signal interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This is not a study involving human interpretation or adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a quality control product for laboratory assays, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The device itself is a control material, not an algorithm. The study implicitly evaluates the standalone performance of the control material in terms of its precision and reaction characteristics when used with immunoturbidimetric assays, by comparing it to a predicate device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for the assigned values of the control product is established through traceability to international and national reference standards:

CRP: CAP/BCR/IFCC Reference Preparation for Proteins in Human Serum
RF: WHO International Reference Preparation of Rheumatoid Arthritis Serum
ASO: Japanese National Standard for ASO

8. The sample size for the training set:

Not applicable. This device is a control product, not an algorithm that requires a training set. The values are assigned based on reference materials, not derived from a machine learning model.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this type of device. The "ground truth" for the control's values is established by its traceability to recognized international and national reference preparations/standards as described in point 7.

Summary

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KC983241/

KAMIYA BIOMEDICAL COMPANY

910 Industry Drive, Seattle, WA 98188 USA

TEL: (206) 575-8068 FAX:(206) 575-8094

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: 206-575-8068; FAX: 206-575-8094
ASO/CRP/RF Control Product:

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
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.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.