This document describes the Immuno Concepts RELISA® SS-A/Ro and SS-B/La Antibody Test System, an enzyme immunoassay for detecting antibodies to nuclear antigens SS-A/Ro and SS-B/La in human serum.

Acceptance Criteria and Device Performance:

The study aimed to demonstrate substantial equivalence to a predicate device (RELISA® ENA Antibody Screening Tests System, K935129) by comparing relative sensitivity, specificity, and overall agreement.

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance (SS-A/Ro)	Reported Device Performance (SS-B/La)
Relative Sensitivity	Not explicitly stated, but implied to be high agreement with predicate.	100.0%	100.0% (after reclassification of 2 samples)
Relative Specificity	Not explicitly stated, but implied to be high agreement with predicate.	100.0%	100.0%
Overall Agreement	Not explicitly stated, but implied to be high agreement with predicate.	100.0%	100.0%

Study Details:

Sample Size and Data Provenance:
- Test Set (SS-A/Ro): 160 samples (62 Positive, 2 Borderline, 96 Negative based on predicate device classification).
- Test Set (SS-B/La): 160 samples (34 Positive, 5 Borderline, 121 Negative based on predicate device classification).
- Data Provenance: Not explicitly stated, but given context of FDA submission, likely from a laboratory setting. The data is retrospective, as it compares the new device's results against those obtained previously with the predicate device.
Number of Experts and Qualifications for Ground Truth:
- The ground truth was established by the predicate device (Immuno Concepts RELISA® Screening Assay (K935129)). No specific human experts or their qualifications are mentioned as being involved in establishing the ground truth for this comparison study, beyond the implied expertise in developing and using the predicate assay.
Adjudication Method for the Test Set:
- No explicit adjudication method (like 2+1 or 3+1) is mentioned. The comparison is direct between the new device and the predicate device's results. For the SS-B/La data, two samples initially classified as "Borderline" by the screening assay were re-classified as "Positive" based on the SS-B(La) specific assay (the new device), which essentially served as an adjudication logic for those specific cases, driven by the new device's result.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not conducted as this is an in-vitro diagnostic device (immunoassay) and not an image-based AI system requiring human reader interpretation. The comparison is between two assays.
Standalone Performance:
- Yes, this study effectively assesses the standalone performance of the new RELISA® SS-A/Ro and SS-B/La Antibody Test System by comparing its results directly against the predicate device. The performance metrics (sensitivity, specificity, agreement) reflect the algorithm's (or assay's) ability to correctly classify samples on its own.
Type of Ground Truth Used:
- The "ground truth" for this study was the results obtained from a legally marketed predicate device (Immuno Concepts RELISA® Screening Assay, K935129). This is a form of comparative ground truth, where the established performance of an existing, approved method serves as the reference.
Sample Size for the Training Set:
- The document does not specify a separate "training set" in the context of machine learning. This is an immunoassay, not a machine learning model that undergoes training on data. The samples mentioned are for evaluating the performance of the developed assay.
How Ground Truth for Training Set was Established:
- Not applicable, as this is an immunoassay evaluation, not a machine learning model where a training set with established ground truth would typically be used. The assay itself embodies the "learned" principles of antigen-antibody detection.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Immuno Concepts. The logo consists of two horizontal lines on the left, followed by the letters "IC" with a stylized design incorporating circles. To the right of "IC" is the word "immuno" stacked on top of the word "concepts".

APR 1 9 1996

Date Prepared: December 4, 1995 Contact Person: Eric S. Hoy, Ph.D. Name of Device:

· Trade Name RELISA® SS-A/Ro and SS-B/La Antibody Test System
· Common Name SS-A/Ro and SS-B/La Antibody Test System
· Classification Name Extractable Antinuclear Antibody (21 CFR 866.5100)

Legally marketed device with which this device has been shown to be equivalent: RELISA® ENA Antibody Screening Tests System, K935129

Description:

This is an enzyme immunoassay for the detection of antibodies to nuclear antigens SS-A/Ro and SS-B/La in human serum.

Intended Use:

This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigens SS-A/Ro and SS-B/La in human serum.

Summary of Technological Characteristics Compared to the Predicate Device:

This device is identical to the predicate device with the following exceptions :

The predicate device has six different autoantigens coated on individual a) microwells; the present device has only SS-A/Ro or SS-B/La autoantigen coated on the microwells.

b) The predicate device includes a procedure control well on each strip of microwells, the present device includes a calibrator serum in the kit.

Description of Laboratory Data That Indicate Substantial Equivalence:

For direct determination of relative sensitivity and specificty, we used the Immuno Concepts RELISA® Screening Assay (K935129) as a reference method. The data obtained in this comparison are shown in the following Tables.

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								Table 1. Detection of antibodies to the SS-A(Ro) autoantigen.
--	--	--	--	--	--	--	--	---------------------------------------------------------------

		Immuno Concepts RELISA® Screening Assay
		Positive	Borderline	Negative
	Positive	62	0	0
Immuno ConceptsRELISA® SS-A/SS-B	Borderline	0	2	0
	Negative	0	0	96

These data yield the following statistics: relative sensitivity, 100.0%; relative specificity, 100.0%; and overall agreement, 100.0%

Table 2. Detection of antibodies to the SS-B(La) autoantigen.
---------------------------------------------------------------	--	--	--	--	--	--	--	--	--

		Immuno Concepts RELISA® Screening Assay Positive	Borderline	Negative
	Positive	32	2	0
Immuno Concepts RELISA® SS-A/SS-B	Borderline	0	5	0
	Negative	0	0	121

The two samples that gave borderline positive results with the screening assay and positive results with the SS-B(La) specific assay are considered positive samples. These data yield the following statistics: relative sensitivity, 100.0%; relative specificity, 100.0%; and overall agreement, 100.0%

In accordance with 21 CFR 807.92(b)(3), we conclude from these data that the present device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 866.5100 Antinuclear antibody immunological test system.

(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).