The Wako RF-HA(2) test is a highly specific reagent based on turbidimetric immunoassay. When the sample is mixed with Buffer and RF Reagent, rheumatoid factor in the sample combines specifically with the heat-aggregated human IgG in the reagents to yield an insoluble aggregate which causes increased turbidity in the solution. The degree of turbidity can be measured optically and is proportional to the amount of rheumatoid factor in the sample.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Wako RF-HA(2) test, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Correlation with predicate device	0.9946 (correlation coefficient)
Regression equation vs. predicate	y = 1.018x - 9.91
Precision	Acceptable values can be obtained on a day-to-day basis
Minimum detectable level	10 IU/mL

Study Details

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

The text does not explicitly state the sample size used for the correlation study.
The data provenance (e.g., country of origin, retrospective/prospective) is not mentioned.

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

This information is not provided. The study compares the Wako RF-HA(2) against a predicate device, not directly against expert interpretations.

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

This information is not applicable/provided as the study focuses on a comparison to a predicate device rather than human adjudication of results.

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:

No, an MRMC comparative effectiveness study was not performed. This device is an in vitro diagnostic assay, not an AI-assisted diagnostic tool for human readers.

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

Yes, the study implicitly focuses on the standalone performance of the Wako RF-HA(2) test. It evaluates the assay's performance (correlation, regression, precision, minimum detectable level) as a direct measurement tool, without human intervention in the result generation or interpretation beyond routine lab procedures.

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

The "ground truth" for this study is essentially the results obtained from the predicate device, Wako Autokit RF product. The comparison is between the new device and an established, legally marketed device.

8. The sample size for the training set:

The text does not mention a separate training set or its sample size. This type of diagnostic assay typically does not involve a "training set" in the machine learning sense. The evaluation is of the finalized assay itself.

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

As there's no mention of a training set, the establishment of "ground truth" for it is not applicable. The comparison is against the predicate device.

Summary

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9 2002 SEP

KO20972

Wako Chemicals USA, Inc. 1600 Bellwood Road, Richmond, VA 23237 U.S.A.

510(k) Summary of Safety and Effectiveness

The Wako RF HA2 test is an in vitro diagnostic assay for the quantitative determination of rheumatoid factor activity in serum.

Summary:

Rheumatoid factor (RF) is contained in the serum of theumatoid arthritis patients. Because of this high degree of specificity, the detection of RF by serologic test has proved to be useful in the clinical diagnosis and prognosis of rheumatoid arthritis.

RF is an autoantibody of human immunoglobulin G (IgG). The most conventional serologic test for RF is the method dependent upon agglutination of particles (e.g., latex and erythrocytes) which have been sensitized with human gamma-globulin. Assays for RF have been improved and more quantitative RF tests have been reported (eg., nephelometric immunoassay and turbidimetric immunoassay).

The turbidimetric immunoasay method (TIA) has the advantages of : ease of use, accurate quantitation, and it is applicable to automated analyzers.

The Wako RF-HA(2) test is a highly specific reagent based on turbidimetric immunoassay.

Principle:

When the sample is mixed with Buffer and RF Reagent, rheumatoid factor in the sample combines specifically with the heat-aggregated human IgG in thereagents to yield an insoluble aggregate which causes increased turbidity in the solution. The degree of turbidity can be measured optically and is proportional to the amount of rheumatoid factor in the sample.

The safety and effectiveness of the Wako RF-HA(2) assay is demonstrated by its substantial equivalency to the Wako Autokit RF product. Both test systems are used to measure rheumatoid factor in serum. In comparison studies against the predicate assay, a correlation coefficient of 0.9946 and a regression equation of y =1.018x - 9.91 was obtained. Precision studies indicate acceptable values can be obtained on a day to day basis. The minimum detectable level of this method is 10 IU/mL.

Xmza Hallm

Tonyà Mallory March 25, 2002 Wako Diagnostics Wako Chemicals USA, Inc. 1600 Bellwood Road Richmond, VA 23237

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and features an abstract image of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are written around the top of the circle.

ood and Drug Administration 2098 Gaither Road Rockville MD 20850

9 2002 SEP

Ms. Tonya Mallory Executive Manager Wako Chemicals USA. Inc. 1600 Bellwood Road Richmond, Virginia 23237

Rc: K020972

Trade/Device Name: Wako RF-HA (2), RF Calibrator, RF Calibrator Set Regulation Number: 21 CFR 866.5775 Regulation Name: Rheumatoid Factor Immunological Test System Regulatory Class: Class II Product Code: DHR, JIT Dated: August 26, 2002 Received: August 27, 2002

Dear Ms. Mallory:

We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 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 (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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer 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 Sutman

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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510(k) Number K020972

Prescription Use (Per 21 CFR 801.109)

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Regulation Number and Section

§ 866.5775 Rheumatoid factor immunological test system.

(a)
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.(b)
Classification. Class II (performance standards).