Who is the manufacturer of RELSIA SCL-70 ANTIBODY TEST SYSTEM?

Immuno Concepts, Inc. filed the 510(k) submission for RELSIA SCL-70 ANTIBODY TEST SYSTEM (K955602).

What is the FDA product code for RELSIA SCL-70 ANTIBODY TEST SYSTEM?

LLL. It is classified under 21 CFR 866.5100 as a Class 2 device in the Immunology panel.

What is the regulatory pathway for RELSIA SCL-70 ANTIBODY TEST SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like RELSIA SCL-70 ANTIBODY TEST SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

RELSIA SCL-70 ANTIBODY TEST SYSTEM

Q: What are the predicate devices for RELSIA SCL-70 ANTIBODY TEST SYSTEM?

RELISA® ENA Antibody Screening Tests System (K935129).

K955602 · Immuno Concepts, Inc. · LLL · Apr 19, 1996 · Immunology

Device Facts

Record ID	K955602
Device Name	RELSIA SCL-70 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 Scl-70 in human serum.

Device Story

RELISA® Scl-70 Antibody Test System; enzyme immunoassay (EIA) for detection of Scl-70 antibodies in human serum. Device utilizes microwells coated with Scl-70 autoantigen. Laboratory-based test; performed by trained technicians. Patient serum sample added to microwells; antibody-antigen binding detected via enzymatic reaction. Output is qualitative/semi-quantitative result indicating presence of Scl-70 antibodies. Results used by clinicians to support diagnosis of autoimmune disorders. Benefits include standardized, specific detection of Scl-70 antibodies compared to broader screening assays.

Clinical Evidence

Bench testing only. Comparison study against predicate RELISA® Screening Assay (K935129) using 177 samples. Results: 37 positive, 3 borderline, 7 borderline, 1 borderline, 129 negative. Assuming borderline as positive: relative sensitivity 97.9%, relative specificity 100%, overall agreement 99.4%.

Technological Characteristics

Enzyme immunoassay (EIA) system. Microwells coated with Scl-70 autoantigen. Includes calibrator serum. Manual or automated plate reader detection. In vitro diagnostic use.

Indications for Use

Indicated for the detection of Scl-70 antibodies in human serum to aid in the diagnosis of systemic sclerosis or related autoimmune conditions.

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)

Related Devices

K990797 — AUTOSTAT II ANTI-SCL-70 ELISA · Cogent Diagnotics , Ltd. · Apr 28, 1999
K983921 — AUTOSTAT II ENA SCREEN ELISA · Cogent Diagnotics , Ltd. · Dec 28, 1998
K970239 — IS-ANTI-SCL-70 TEST SYSTEM (720-280) · Diamedix Corp. · Apr 8, 1997
K983423 — THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE · Zeus Scientific, Inc. · Nov 18, 1998
K113143 — IMMULISA SCI-70 ANTIBODY ELISA · Immco Diagnostics, Inc. · Dec 2, 2011

Submission Summary (Full Text)

{0} K955602 APR 19 1996 # 510(k) SUMMARY Date Prepared: December 4, 1995 Contact Person: Eric S. Hoy, Ph.D. Name of Device: - Trade Name - RELISA® Scl-70 Antibody Test System - Common Name - Scl-70 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 Scl-70 in human serum. Intended Use: This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigen Scl-70 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 Scl-70 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 (916) 363-2649-(800) 251-5115-FAX: (916) 363-2843 {1} K 955402 Table 1. Detection of antibodies to the Scl-70 autoantigen. | | | Immuno Concepts RELISA® Screening Assay | | | | --- | --- | --- | --- | --- | | | | Positive | Borderline | Negative | | Immuno Concepts RELISA® Scl-70 | Positive | 37 | 3 | 0 | | | Borderline | 0 | 7 | 0 | | | Negative | 0 | 1 | 129 | If we assume that "borderline" results are actually positive, these data yield the following statistics: relative sensitivity, 97.9%; relative specificity, 100%; 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.