Product code LLL
- Device name
- Extractable Antinuclear Antibody, Antigen And Control
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5100
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250666 | Alegria Flash CTD Screen | Zeus Scientific | 2025-10-22 |
| K250408 | Alegria Flash ENA Screen | Zeus Scientific | 2025-09-19 |
| K213403 | Aptiva CTD Essential Reagent | Inova Diagnostics, Inc. | 2023-09-29 |
| K190710 | EliA SymphonyS Immunoassay | Phadia AB | 2019-11-29 |
| K180975 | QUANTA Flash HMGCR Reagents | Inova Diagnostics, Inc. | 2018-06-25 |
| K152635 | QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls | Inova Diagnostics, Inc. | 2016-06-01 |
| K151429 | QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols | Inova Diagnostics, Inc. | 2016-02-12 |
| 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. | 2015-03-31 |
| K141328 | QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS | Inova Diagnostics, Inc. | 2015-02-12 |
| K141210 | QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS | Inova Diagnostics, Inc. | 2015-01-29 |
| K122923 | QUANTA FLASH ENA7 | Inova Diagnostics, Inc. | 2013-05-07 |
| K112996 | EUROIMMUN ANTI-ENA POOL ELISA (IGG) | Euroimmun US | 2013-04-09 |
| K113143 | IMMULISA SCI-70 ANTIBODY ELISA | Immco Diagnostics, Inc. | 2011-12-02 |
| K102607 | FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS | Biomedical Diagnostics (Bmd) SA | 2010-12-03 |
| K072149 | ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 | Phadia US, Inc. | 2008-01-15 |
| K053653 | FIDIS CONNECTIVE 10, MODEL MX006 | Biomedical Diagnostics (Bmd) SA | 2006-03-13 |
| K050286 | FIDIS CONNECTIVE 8 | Biomedical Diagnostics (Bmd) SA | 2005-10-03 |
| K043067 | ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400 | Bioarray Solutions, Ltd. | 2005-05-31 |
| K041753 | AESKULISA ENA 6 S | Aesku Diagnostics | 2004-07-14 |
| K040160 | QUANTA PLEX SLE PROFILE 8 | Inova Diagnostics, Inc. | 2004-03-08 |
| K033528 | MESACUP-2 TEST JO-1, MODEL 10756 | Rhigene, Inc. | 2003-12-22 |
| K032469 | AESKULISA ANA 8PRO | Aesku, Inc. | 2003-12-16 |
| K031450 | QUANTA PLEX ENA PROFILE 6 | Inova Diagnostics, Inc. | 2003-06-25 |
| K030681 | QUANTA PLEX ENA PROFILE 5 | Inova Diagnostics, Inc. | 2003-04-24 |
| K011140 | QUANTA PLEX ENA PROFILE 4 | Inova Diagnostics, Inc. | 2001-07-27 |
| K010146 | ENA EIA KIT RANGE | The Binding Site, Ltd. | 2001-03-01 |
| K010147 | ENA EIA KIT | The Binding Site, Ltd. | 2001-03-01 |
| K010148 | ENA SCREEN EIA KIT | The Binding Site, Ltd. | 2001-02-23 |
| K003057 | AUTOSTAT II ENA-4 PROFILE ELISA | Cogent Diagnotics , Ltd. | 2000-10-13 |
| K003054 | AUTOSTAT II ENA-6 PROFILE ELISA | Cogent Diagnotics , Ltd. | 2000-10-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00894175000725 | AccuDiag™ ENA Profile-6 (Sm/RNP, Sm, Jo-1, Scl-70, SS-A, SS-B) ELISA | Diagnostic Automation, Inc. | 2026-02-27 |
| 07333066016115 | EliA SymphonyS Well | Phadia AB | 2020-06-30 |
| 08426950793182 | QUANTA Flash® HMGCR Reagents | INOVA DIAGNOSTICS, INC. | 2018-10-31 |
| 08426950595786 | QUANTA Flash® SS-B Reagents | INOVA DIAGNOSTICS, INC. | 2017-08-28 |
| 00845714004247 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-12-09 |
| 00845714002922 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-12-09 |
| 00845714002786 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-12-09 |
| 00845714002960 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-10-27 |
| 10080196000616 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 07333066014593 | EliA Symphony Well | Phadia AB | 2016-09-23 |
| 05391516747646 | Trinity Biotech | MARDX DIAGNOSTICS, INC. | 2016-09-19 |
| 00847865002448 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865000093 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865000086 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865001342 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865002721 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 08426950593461 | NOVA Lite® HEp-2 ANA Kit | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950454373 | QUANTA Lite® ANA ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950456193 | NOVA Lite® HEp-2 ANA Kit | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950454502 | QUANTA Lite® dsDNA ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950724476 | QUANTA Flash® Scl-70 Reagents | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950595878 | QUANTA Flash® Ro60 Reagents | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950595410 | QUANTA Flash® Jo-1 Reagents | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950514015 | QUANTA Lite® Jo-1 ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950506331 | QUANTA Lite® Histone ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950456186 | QUANTA Lite® Scl-70 ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950456179 | QUANTA Lite® SS-B ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950456162 | QUANTA Lite® SS-A ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950456155 | QUANTA Lite® RNP ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950456148 | QUANTA Lite® Sm ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |