RELISA SM/RNP ANTIBODY TEST SYSTEM

K955604 · Immuno Concepts, Inc. · LLL · Apr 19, 1996 · Immunology

Device Facts

• Record ID: K955604
• Device Name: RELISA SM/RNP ANTIBODY TEST SYSTEM
• Applicant: Immuno Concepts, Inc.
• Product Code: LLL · Immunology
• Decision Date: Apr 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

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.

Device Story

Enzyme immunoassay (EIA) for detection of anti-Sm and anti-RNP antibodies in human serum; utilizes microwells coated with Sm or Sm/RNP complex autoantigens; laboratory-based diagnostic test; provides qualitative/semi-quantitative results to clinicians for aid in diagnosis of autoimmune conditions; replaces multi-antigen screening with specific antigen testing; includes calibrator serum for quality control.

Clinical Evidence

Bench testing only. Comparison study against predicate (K935129) using human serum samples. Sm assay (n=138): 100% relative sensitivity, 100% relative specificity, 100% overall agreement. RNP assay (n=138): 100% relative sensitivity, 100% relative specificity, 100% overall agreement.

Technological Characteristics

Enzyme immunoassay (EIA); microwells coated with Sm or Sm/RNP complex autoantigens; includes calibrator serum; in vitro diagnostic test system.

Indications for Use

Indicated for in vitro diagnostic detection of antibodies to nuclear antigens Sm (Smith) and RNP (U1-RNP or ribonucleoprotein) in human serum.

Regulatory Classification

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).

Predicate Devices

• RELISA® ENA Antibody Screening Tests System (K935129)

Submission Summary (Full Text)

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K955604

# 510(k) SUMMARY

- 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:

a) The predicate device has six different autoantigens coated on individual 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 specificity, 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.

Immuno Concepts Incorporated, 9779 "D" Business Park Drive, Sacramento, CA 95827
[phone] · [phone] · FAX: [phone]

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K 955604

Table 1. Detection of antibodies to the Sm autoantigen.

| | | Immuno Concepts RELISA® Screening Assay | | |
| --- | --- | --- | --- | --- |
| | | Positive | Borderline | Negative |
| Immuno Concepts RELISA® Sm/RNP | Positive | 32 | 0 | 0 |
| | Borderline | 0 | 4 | 0 |
| | Negative | 0 | 0 | 102 |

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.

| | | Immuno Concepts RELISA® Screening Assay | | |
| --- | --- | --- | --- | --- |
| | | Positive | Borderline | Negative |
| Immuno Concepts RELISA® 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.