RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM

K955603 · Immuno Concepts, Inc. · LLL · Apr 19, 1996 · Immunology

Device Facts

• Record ID: K955603
• Device Name: RELSIA SS-A/RO & SS/B LA 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 SS-A/Ro and SS-B/La in human serum.

Device Story

Enzyme immunoassay (EIA) for detection of antibodies to nuclear antigens SS-A/Ro and SS-B/La in human serum; utilizes microwells coated with specific autoantigens; laboratory-based diagnostic test; provides qualitative/semi-quantitative results to clinicians; aids in diagnosis of autoimmune conditions associated with anti-SS-A/Ro and anti-SS-B/La antibodies.

Clinical Evidence

Bench-only clinical comparison against predicate (K935129). SS-A/Ro study (n=160): 100% sensitivity, 100% specificity, 100% agreement. SS-B/La study (n=160): 100% sensitivity, 100% specificity, 100% agreement.

Technological Characteristics

Enzyme immunoassay (EIA); microwells coated with SS-A/Ro or SS-B/La autoantigens; includes calibrator serum; in vitro diagnostic test system.

Indications for Use

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

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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K955603

Immuno Concepts

APR 19 1996

# 510(k) SUMMARY

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:
a) The predicate device has six different autoantigens coated on individual 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 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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K955603

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

| | | Immuno Concepts RELISA® Screening Assay | | |
| --- | --- | --- | --- | --- |
| | | Positive | Borderline | Negative |
| Immuno Concepts RELISA® SS-A/SS-B | Positive | 62 | 0 | 0 |
| | 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 |
| Immuno Concepts RELISA® SS-A/SS-B | Positive | 32 | 2 | 0 |
| | 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.