RELISA JO-1 ANTIBODY TEST SYSTEM

K955605 · Immuno Concepts, Inc. · LLL · Apr 19, 1996 · Immunology

Device Facts

• Record ID: K955605
• Device Name: RELISA JO-1 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 antigen Jo-1 in human serum.

Device Story

Enzyme immunoassay (EIA) for detection of Jo-1 antibodies in human serum; utilizes microwells coated with Jo-1 autoantigen; intended for laboratory use; provides qualitative/semi-quantitative results to assist clinicians in diagnosing autoimmune conditions; results interpreted by healthcare professionals to support clinical decision-making.

Clinical Evidence

Bench testing comparison against predicate RELISA® Screening Assay (K935129). Sample size n=169. Results: 100% relative sensitivity, 99.3% relative specificity, 99.4% overall agreement (treating borderline as positive).

Technological Characteristics

Enzyme immunoassay (EIA); microwells coated with Jo-1 autoantigen; includes calibrator serum; manual or automated plate processing; in vitro diagnostic use.

Indications for Use

Indicated for in vitro diagnostic detection of Jo-1 nuclear antigen antibodies 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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K955605

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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® Jo-1 Antibody Test System
- Common Name - Jo-1 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 antigen Jo-1 in human serum.

Intended Use:

This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigen Jo-1 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 Jo-1 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 Table.

Immuno Concepts Incorporated·9779 "D" Business Park Drive·Sacramento, CA 95827

[phone]·[phone]·FAX: [phone]

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K955605

Table 1. Detection of antibodies to the Jo-1 autoantigen.

| | | Immuno Concepts RELISA® Screening Assay | | |
| --- | --- | --- | --- | --- |
| | | Positive | Borderline | Negative |
| Immuno Concepts RELISA® Jo-1 | Positive | 21 | 1 | 0 |
| | Borderline | 2 | 4 | 1 |
| | Negative | 0 | 0 | 140 |

If we assume that "borderline" results are actually positive, these data yield the following statistics: relative sensitivity, 100.0%; relative specificity, 99.3%; and overall agreement, 99.4%

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.