LLL · Extractable Antinuclear Antibody, Antigen And Control
Immunology · 21 CFR 866.5100 · Class 2
Overview
| Product Code | LLL |
|---|---|
| Device Name | Extractable Antinuclear Antibody, Antigen And Control |
| Regulation | 21 CFR 866.5100 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
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).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 180)
Showing 20 most recent of 180 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250666 | Alegria Flash CTD Screen | Zeus Scientific | Oct 22, 2025 | SESE |
| K250408 | Alegria Flash ENA Screen | Zeus Scientific | Sep 19, 2025 | SESE |
| K213403 | Aptiva CTD Essential Reagent | Inova Diagnostics, Inc. | Sep 29, 2023 | SESE |
| K190710 | EliA SymphonyS Immunoassay | Phadia AB | Nov 29, 2019 | SESE |
| K180975 | QUANTA Flash HMGCR Reagents | Inova Diagnostics, Inc. | Jun 25, 2018 | SESE |
| K152635 | QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls | Inova Diagnostics, Inc. | Jun 1, 2016 | SESE |
| K151429 | QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols | Inova Diagnostics, Inc. | Feb 12, 2016 | SESE |
| 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 | SESE |
| K141328 | QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS | Inova Diagnostics, Inc. | Feb 12, 2015 | SESE |
| K141210 | QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS | Inova Diagnostics, Inc. | Jan 29, 2015 | SESE |
| K122923 | QUANTA FLASH ENA7 | Inova Diagnostics, Inc. | May 7, 2013 | SESE |
| K112996 | EUROIMMUN ANTI-ENA POOL ELISA (IGG) | Euroimmun US | Apr 9, 2013 | SESE |
| K113143 | IMMULISA SCI-70 ANTIBODY ELISA | Immco Diagnostics, Inc. | Dec 2, 2011 | SESE |
| K102607 | FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS | Biomedical Diagnostics (Bmd) SA | Dec 3, 2010 | SESE |
| K072149 | ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 | Phadia US, Inc. | Jan 15, 2008 | SESE |
| K053653 | FIDIS CONNECTIVE 10, MODEL MX006 | Biomedical Diagnostics (Bmd) SA | Mar 13, 2006 | SESE |
| K050286 | FIDIS CONNECTIVE 8 | Biomedical Diagnostics (Bmd) SA | Oct 3, 2005 | SESE |
| K043067 | ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400 | Bioarray Solutions, Ltd. | May 31, 2005 | SESE |
| K041753 | AESKULISA ENA 6 S | Aesku Diagnostics | Jul 14, 2004 | SESE |
| K040160 | QUANTA PLEX SLE PROFILE 8 | Inova Diagnostics, Inc. | Mar 8, 2004 | SESE |
Top Applicants
- Inova Diagnostics, Inc. — 37 clearances
- Hemagen Diagnostics, Inc. — 16 clearances
- Hycor Biomedical, Inc. — 10 clearances
- Diamedix Corp. — 10 clearances
- Immuno Concepts, Inc. — 8 clearances
