← Product Code [LLL](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LLL) · K963275 # RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM (K963275) _Immuno Concepts, Inc. · LLL · Sep 13, 1996 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LLL/K963275 ## Device Facts - **Applicant:** Immuno Concepts, Inc. - **Product Code:** [LLL](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LLL.md) - **Decision Date:** Sep 13, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.5100 - **Device Class:** Class 2 - **Review Panel:** Immunology ## 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. ## Regulatory 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](/device/K935129.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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. --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LLL/K963275](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/LLL/K963275) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com