Who is the manufacturer of RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM?

Immuno Concepts, Inc. submitted the Traditional clearance for RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM (K963275).

What is the FDA product code for RELISA ENA SINGLE WELL SCREEN 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 RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM?

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

RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM

K963275 · Immuno Concepts, Inc. · LLL · Sep 13, 1996 · Immunology

Device Facts

Record ID	K963275
Device Name	RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM
Applicant	Immuno Concepts, Inc.
Product Code	LLL · Immunology
Decision Date	Sep 13, 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, RNP, SS-A/Ro, SS-B/La, Scl-70, or Jo-1 in human serum. The results from this assay can be used as an aid in the diagnosis of autoimmune diseases.

Device Story

Enzyme immunoassay (EIA) for detection of antibodies to extractable nuclear antigens (Sm, RNP, SS-A/Ro, SS-B/La, Scl-70, Jo-1) in human serum. Input: human serum sample. Transformation: antigens coated on single microwell bind specific antibodies; enzyme-linked detection produces colorimetric signal proportional to antibody concentration. Output: qualitative/semi-quantitative antibody presence. Used in clinical laboratories by technicians. Results aid physicians in diagnosing autoimmune diseases.

Clinical Evidence

Bench testing comparing subject device to predicate (K935129) using human serum samples. N=543. Results: relative sensitivity 97.9%, relative specificity 97.8%, overall agreement 97.8% (treating borderline as positive).

Technological Characteristics

Enzyme immunoassay; six autoantigens (Sm, RNP, SS-A/Ro, SS-B/La, Scl-70, Jo-1) coated on single microwell; colorimetric detection; in vitro diagnostic kit format.

Indications for Use

Indicated for in vitro diagnostic detection of antibodies to Sm, RNP, SS-A/Ro, SS-B/La, Scl-70, or Jo-1 in human serum to aid in autoimmune disease diagnosis.

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 Multiparameter Antibody Screening Test System (K935129)

Related Devices

K964787 — MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM · Mardx Diagnostics, Inc. · Apr 8, 1997
K980811 — SERAQUEST ANTI-SM/RNP · Quest Intl., Inc. · May 12, 1998
K142781 — ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA · Immco Diagnostics, Inc. · Mar 31, 2015
K983921 — AUTOSTAT II ENA SCREEN ELISA · Cogent Diagnotics , Ltd. · Dec 28, 1998
K250408 — Alegria Flash ENA Screen · Zeus Scientific · Sep 19, 2025

Submission Summary (Full Text)

{0} SEP 13 1996 K963275 # 510(k) SUMMARY Date Prepared: August 12, 1996 Contact Person: Eric S. Hoy, Ph.D. Name of Device: - Trade Name - RELISA® ENA Single Well Screen Antibody Test System - Common Name - ENA Single Well Screen 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 Multiparameter Antibody Screening Test System, K935129 Description: This is an enzyme immunoassay for the detection of antibodies to extractable nuclear antigens Sm, RNP, SS-A/Ro, SS-B/La, Scl-70, or Jo-1 in human serum. Intended Use: This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigens Sm, RNP, SS-A/Ro, SS-B/La, Scl-70, or Jo-1 in human serum. The results from this assay can be used as an aid in the diagnosis of autoimmune diseases. 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 all six autoantigens coated on a single microwell. 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® Multiparameter ENA 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} | | Immuno Concepts | RELISA® Positive | Multiparameter Borderline | ENA Screening Test Negative | | --- | --- | --- | --- | --- | | | Positive | 126 | 9 | 5 | | Immuno Concepts | | | | | | RELISA® Single Well | Borderline | 0 | 2 | 4 | | ENA Screening Test | | | | | | | Negative | 1 | 2 | 394 | If we consider borderline results to be positive, these data yield the following statistics: relative sensitivity, 97.9%; relative specificity, 97.8%; and overall agreement, 97.8% 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.