This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigens Sm, RNP, SS-A/RO, SS-B/La, Scl-70, or Jo-1 in human serum. The results from this assay can be used as an aid in the diagnosis of autoimmune diseases.

Device Description

This is an enzyme immunoassay for the detection of antibodies to extractable nuclear antigens Sm, RNP, SS-A/RO, SS-B/La, Scl-70, or Jo-1 in human serum.

AI/ML Overview

Here's an analysis of the provided text to extract the requested information about device acceptance criteria and the supporting study:

1. A table of acceptance criteria and the reported device performance

Based on the provided text, the acceptance criteria are not explicitly stated as distinct criteria, but rather are inferred from the performance metrics (sensitivity, specificity, and overall agreement) presented to demonstrate substantial equivalence to a predicate device. The performance is reported in relation to the predicate device.

Performance Metric	Acceptance Criteria (Inferred from equivalence claim)	Reported Device Performance (RELISA® ENA Single Well Screen)
Relative Sensitivity	High (to show equivalence with predicate)	97.9%
Relative Specificity	High (to show equivalence with predicate)	97.8%
Overall Agreement	High (to show equivalence with predicate)	97.8%

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

Test set sample size:
- The table indicates the total number of samples tested by referring to the "Immuno Concepts RELISA® Multiparameter ENA Screening Test" as the reference method.
- Total samples = 126 (Positive) + 9 (Positive) + 5 (Positive) + 0 (Borderline) + 2 (Borderline) + 4 (Borderline) + 1 (Negative) + 2 (Negative) + 394 (Negative) = 543 samples
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective).

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 in the text. The "ground truth" or reference method for comparison is the "Immuno Concepts RELISA® Multiparameter ENA Screening Assay (K935129)," which is another diagnostic test, not expert opinion.

4. Adjudication method for the test set

This information is not applicable/provided. The "ground truth" was established by a predicate diagnostic device, not by human experts requiring 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

This is not an MRMC study. The device is an in vitro diagnostic test (enzyme immunoassay) for detecting antibodies, not an AI system for image interpretation or diagnosis by human readers. Therefore, this question is not relevant to the provided study description.

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

Yes, this study is inherently a standalone performance evaluation of the RELISA® ENA Single Well Screen Antibody Test System. It compares the device's results directly against a predicate diagnostic device without human interpretation as part of the primary measurement.

7. The type of ground truth used

The "ground truth" (or reference standard in this context) used was the Immuno Concepts RELISA® Multiparameter ENA Screening Assay (K935129). This is a previously cleared, legally marketed diagnostic device.

8. The sample size for the training set

The text does not provide information on a training set. This study describes a performance comparison of a final device against a predicate, which aligns with verification/validation testing rather than a description of the model development phase.

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

As there's no mention of a training set, this information is not applicable/provided.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Immuno Concepts. The logo consists of two horizontal lines on the left, followed by a stylized "IC" symbol. To the right of the symbol is the word "immuno" in a sans-serif font, stacked above the word "concepts" in the same font. The logo is black and white.

SEP 13 1996

<963275

STO(K) COMMUNITY

Date Prepared: August 12, 1996 Contact Person: Eric S. Hoy, Ph.D. Name of Device:

· Trade Name RELISA® ENA Single Well Screen Antibody Test System
· Common Name ENA Single Well Screen 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 Multiparameter Antibody Screening Test System, K935129

Description:

This is an enzyme immunoassay for the detection of antibodies to extractable nuclear antigens Sm, RNP, SS-A/RO, SS-B/La, Scl-70, or Jo-1 in human serum.

Intended Use:

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 all six autoantigens coated on a single microwell.

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® Multiparameter ENA Screening Assay (K935129) as a reference method. The data obtained in this comparison are shown in the following Table.

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Immuno Concepts RELISA® Multiparameter ENA Screening Test Negative Positive Borderline

	Positive	126	9	5
Immuno ConceptsRELISA® Single WellENA Screening Test	Borderline	0	2	4
	Negative	1	2	394

If we consider borderline results to be positive, these data yield the following statistics: relative sensitivity, 97.9%; relative specificity, 97.8%; and overall agreement, 97.8%

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).