This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigens Sm (Smith) and RNP (U1-RNP or ribonucleoprotein) in human serum.

Device Description

This is an enzyme immunoassay for the detection of antibodies to nuclear antigens Sm (Smith) and RNP (U1-RNP or ribonucleoprotein) in human serum.

AI/ML Overview

The provided text describes a RELISA® Sm/RNP Antibody Test System which is an enzyme immunoassay for the detection of antibodies to nuclear antigens Sm (Smith) and RNP (U1-RNP or ribonucleoprotein) in human serum.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical thresholds in the provided text. Instead, the study aims to demonstrate substantial equivalence to a predicate device (RELISA® ENA Antibody Screening Tests System, K935129) by showing high relative sensitivity, relative specificity, and overall agreement. Based on the reported results, it appears the acceptance criteria were implicitly 100% for all these metrics compared to the predicate.

Metric	Acceptance Criteria (Implicit)	Reported Device Performance (Sm Autoantigen)	Reported Device Performance (RNP Autoantigen)
Relative Sensitivity	100%	100.0%	100.0%
Relative Specificity	100%	100.0%	100.0%
Overall Agreement	100%	100.0%	100.0%

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Sm Autoantigen):
- Positive: 32
- Borderline: 4
- Negative: 102
- Total: 138 samples
Sample Size (RNP Autoantigen):
- Positive: 40
- Borderline: 5
- Negative: 93
- Total: 138 samples
Data Provenance: Not explicitly stated in the provided text (e.g., country of origin, retrospective or prospective). It is simply referred to as "human serum" used in direct comparison with the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The "ground truth" for this study was established using a predicate device, not human experts.

4. Adjudication Method for the Test Set

Not applicable. There was no human adjudication as the comparison was made against a predicate device.

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 study does not involve AI assistance or human readers in the context of an MRMC study. It's a direct comparison of a new immunoassay device against an existing immunoassay device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense. The study evaluated the standalone performance of the new device (Immuno Concepts RELISA® Sm/RNP) by directly comparing its results to the standalone performance of the predicate device (Immuno Concepts RELISA® Screening Assay). There is no human interpretion involved in the comparison, only the output of the immunoassay devices.

7. The Type of Ground Truth Used

The ground truth used was the results obtained from a legally marketed predicate device (Immuno Concepts RELISA® Screening Assay, K935129). This is a form of reference method comparison, where the established performance of the predicate serves as the gold standard for evaluating the new device.

8. The Sample Size for the Training Set

Not applicable. This type of immunoassay device development and validation typically does not involve a "training set" in the machine learning sense. The device is chemical/biological in nature, and its parameters are established through laboratory optimization and validation, not through learning from a labeled dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of this device and study design.

Summary

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K955604

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 the "I" being a thick vertical line and the "C" being a circle with two smaller circles inside. To the right of the "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® Sm/RNP Antibody Test System
· Common Name Sm/RNP 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 Sm (Smith) and RNP (U1-RNP or ribonucleoprotein) in human serum.

Intended Use:

This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigens Sm (Smith) and RNP (U1-RNP or ribonucleoprotein) 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 Sm (Smith) or the Sm/RNP (Smith/ribonucleoprotein) complex 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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K 955604

		Immuno Concepts RELISA® Screening AssayPositive	Borderline	Negative
Immuno ConceptsRELISA® Sm/RNP	Positive	32	0	0
	Borderline	0	4	0
	Negative	0	0	102

Table 1. Detection of antibodies to the Sm autoantigen.

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 RNP autoantigen.

		Positive	Immuno Concepts RELISA® Screening AssayBorderline	Negative
Immuno ConceptsRELISA® Sm/RNP	Positive	40	0	0
	Borderline	0	5	0
	Negative	0	0	93

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).