RaPET RF (Class II) is intended for the qualitative and semi-quantitative detection of rheumatoid factor in human serum. The latex slide test is intended to be used as an aid in the diagnosis of rheumatoid arthritis.

Device Description

The device test kit is comprised of RF Latex Reagent, RF Positive Control. Negative Control and Glycine/Saline Buffer for performing semi-quantitative testing.

AI/ML Overview

Here's an analysis of the provided information regarding the RaPET® RF device, focusing on its acceptance criteria and the study used to demonstrate it:

Acceptance Criteria and Device Performance for RaPET® RF

The RaPET® RF device is a latex slide test intended for the qualitative and semi-quantitative detection of rheumatoid factor in human serum, to be used as an aid in the diagnosis of rheumatoid arthritis.

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Method Comparison	Correlation coefficient of 0.998 with a regression equation of Y=1.003X - 2.82 when compared to an unspecified predicate RF latex method.
Precision	Results found to be acceptable. (Specific thresholds not provided)
Sensitivity	Results found to be acceptable. (Specific thresholds not provided)
Specificity	Results found to be acceptable. (Specific thresholds not provided)
Interference	Results found to be acceptable. (Specific thresholds not provided)

Note: The specific numerical acceptance criteria (e.g., minimum correlation coefficient, ranges for precision, sensitivity, and specificity) are not explicitly stated in the provided summary. The statement "Results of these tests were found to be acceptable" indicates that the device met internal or regulatory predefined criteria, but the criteria themselves are not detailed.

2. Sample Size and Data Provenance for the Test Set

Sample Size: The sample size used for the method comparison and other studies (precision, sensitivity, specificity, interference) is not specified in the provided document.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

Number of Experts: The document does not specify the number of experts used to establish ground truth for the test set.
Qualifications of Experts: The document does not specify the qualifications of any experts involved in establishing ground truth. Since this is an in-vitro diagnostic device, ground truth often refers to a reference method or clinical diagnosis rather than expert interpretation of images. However, if any such interpretation was part of the study, it's not detailed.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method. For in-vitro diagnostic devices like this, an adjudication method (like 2+1, 3+1) is typically associated with studies involving human interpretation or subjective assessments, which are not the primary focus of an RF latex test validation. The "ground truth" would likely be established by a reference method or clinical diagnosis itself.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not explicitly mentioned or performed as described for this device. This type of study focuses on how human readers' performance (e.g., diagnostic accuracy) is affected by AI assistance, which is not applicable to a manual latex agglutination test that does not involve "readers" in the same sense as an imaging AI.

6. Standalone Performance Study

A standalone study was performed in the sense that the device's performance characteristics (precision, sensitivity, specificity, interference) were evaluated as an algorithm/device only, without human-in-the-loop performance being a primary metric. The method comparison also evaluates the device's standalone output against a predicate device's output.

7. Type of Ground Truth Used

The primary ground truth for the method comparison appears to be the results obtained from a predicate RF latex method.
For precision, sensitivity, specificity, and interference studies, the ground truth would typically be established based on:

Reference method/clinical diagnosis: For sensitivity and specificity, indicating the true presence or absence of rheumatoid factor/rheumatoid arthritis.
Known concentrations: For precision studies using controls with known analyte concentrations.
Known interferents: For interference studies, using samples spiked with known interfering substances.
The document provides no further specifics on these ground truth methods.

8. Sample Size for the Training Set

Training Set Sample Size: The document does not specify a training set sample size. For traditional in-vitro diagnostic kits like RaPET® RF, which are based on biochemical reactions (latex agglutination), there isn't typically a "training set" in the machine learning sense. The device itself is designed and optimized, and its performance is then validated.

9. How Ground Truth for the Training Set Was Established

As there is no explicit "training set" in the machine learning context for this device, a method for establishing its ground truth is not applicable or described in the provided document. The development of such a test relies on established biochemical principles and experimental validation, rather than algorithmic training on a dataset.

Summary

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K974370

510(k) Summarv RaPET® RF

FEB 17 1998

Submitter's Name Kirk Johnson Stanbio Laboratory. Inc. 2930 East Houston Street San Antonio, TX 78202

Tel. (210) 222-2108 Fax (210) 227-6367

Prepared By Kirk Johnson November 14, 1997

Product Name Trade Name: RaPET® RF Common Name: Rheumatoid Factor Test Classification Number: 82DHR

Description of Device

The device test kit is comprised of RF Latex Reagent, RF Positive Control. Negative Control and Glycine/Saline Buffer for performing semi-quantitative testing.

Intended Use of Device

RaPET® RF is intended for the qualitative and semi-quantitative detection of rheumatoid factor in human serum. The latex slide test is intended to be used as an aid in the diagnosis of rheumatoid arthritis.

Comparison of Devices

Both RF latex methods employ latex beads coated with human gamma alobulin which agalutinate in the presence rheumatoid arthritis serum.

Performance Data

Substantial equivalency was demonstrated by method comparison. Correlation was performed between the two test kits with a correlation coefficient of 0.998 and a regression equation of Y=1.003X - 2.82.

In addition, precision, sensitivity, specificity, and interference studies were performed on RaPET® RF. Results of these tests were found to be acceptable.

ORATORY, INC.
ston Street
on Antonio, Texas 78202

(210) 222-2108
-800-531-5535
AX (210) 227-6367
mp://www.stanbio.com

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Kirk Johnson Quality Assurance Manager Stanbio Laboratory, Inc. 2930 East Houston Street San Antonio, TX 78202

FEB 1 7 1998

Re: K974370 Trade Name: RaPET RF Regulatory Class: II Product Code: DHR 82 November 18, 1997 Dated: November 20, 1997 Received:

Dear Mr. Johnson:

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 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 In addition, FDA may publish further regulatory action. 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 requlations.

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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 (770)488-7655.

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" (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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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 (if known):	K974370
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Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Peter E. Makim

(Division Sign-Off)
Division of Clinical Laboratory Devices K974370
510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

V Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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).