Antinuclear Antibody, Antigen, Control
FDA product code LKJ · Class II (moderate risk) · 21 CFR 866.5100 · Immunology
50510(k) clearances
0PMA approvals
13recalls
Manufacturers
- Bio-Rad 9
- Elias U.S.A., Inc. 3
- Zeus Scientific, Inc. 3
- Biostar Medical Products, Inc. 2
- Hycor Biomedical, Inc. 2
- Helix Diagnostics, Inc. 2
- Bio-Rad Laboratories, Inc. 2
- Shield Diagnostics, Ltd. 2
- Immco Diagnostics, Inc. 2
- Autoimmunity Diagnostics Corp. 1
- Diagnostic Technology, Inc. 1
- Hemagen Diagnostics, Inc. 1
- Phadia AB 1
- Diagnostic Resources, Inc. 1
- Clark Laboratories, Inc. 1
- Sigma Diagnostics, Inc. 1
- Cytotech, Inc. 1
- Val Tech Diagnostics, Inc. 1
- Kallestad Laboratories, Inc. 1
- Seragen Diagnostics, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K210902 | EliA Ro52, EliA Ro60LKJ · Traditional | Phadia AB | 07/27/2022SE |
| K113610 | Ana-Screen with MDSSLKJ · Special | Bio-Rad Laboratories | 07/09/2012SE |
| K082759 | Elia Cenp Immunoassay, Elia U1RNP Immunoassay, Elia SM Immunoassay, Elia Ro ImmunoassayLKJ · Traditional | Phadia US, Inc. | 04/10/2009SE |
| K081104 | Aeskulisa Ana HEP-2, Ref 30-7115USLKJ · Traditional | Aesku Diagnostics | 05/02/2008SE |
| K041658 | Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex…LKJ · Traditional | Bio-Rad Laboratories, Inc. | 12/20/2004SE |
| K042416 | Athena Multi-Lyte Ana-Ii Test SystemLKJ · Special | Zeus Scientific, Inc. | 10/08/2004SE |
| K034013 | Reaads Dsdna Quantitative Test Kit, Model 022-001LKJ · Special | Corgenix, Inc. | 01/08/2004SE |
| K030775 | Auto I.D. JO-1, SCL-70 & Pcna Positive Control SerumLKJ · Abbreviated | Immuno Concepts, N.A. , Ltd. | 05/12/2003SE |
| K024232 | Liquichek Anti-Ss-B Control, Positive, Catalog #113LKJ · Traditional | Bio-Rad | 01/17/2003SE |
| K024218 | Liquichek Anti-Ss-A Control, Positive, Catalog #114LKJ · Traditional | Bio-Rad | 01/17/2003SE |
| K024223 | Liquichek Anti-Rnp Control, Positive, Catalog #116LKJ · Traditional | Bio-Rad | 01/13/2003SE |
| K024226 | Liquichek ANTI-SCL-70 Control, Positive, Catalog #116LKJ · Traditional | Bio-Rad | 01/10/2003SE |
| K021257 | Ana Line Blot, Catalog Number: Kalabi (20 Tests)LKJ · Traditional | Diagnostic Products Corp. | 06/03/2002SE |
| K021103 | Modification to Zeus Scientific's Athena Multi-Lyte Ana Test SystemLKJ · Special | Zeus Scientific, Inc. | 04/24/2002SE |
| K011244 | Zeus Scientific, Inc. Athena Multi-Lyte Ana Test SystemLKJ · Traditional | Zeus Scientific, Inc. | 12/10/2001SE |
| K993294 | Diamedix Is-Ana Elisa Screen Test SystemLKJ · Traditional | Diamedix Corp. | 10/25/1999SE |
| K984478 | Liquichek Anti-Ss-B Control, Eia, Model 210LKJ · Traditional | Bio-Rad | 12/22/1998SE |
| K984475 | Liquichek ANTI-SCL-70 Control, Eia, Model 212LKJ · Traditional | Bio-Rad | 12/22/1998SE |
| K984473 | Liquichek Ana Control, Eia Screen, Model 205LKJ · Traditional | Bio-Rad | 12/22/1998SE |
| K984470 | Liquichek Anti-Ss-A Control, Eia, Model 209LKJ · Traditional | Bio-Rad | 12/22/1998SE |
| K984464 | Liquichek Anti-Jo 1 Control, Eia, Model No. 211LKJ · Traditional | Bio-Rad | 12/22/1998SE |
| K961815 | Qualitrol Ana Control Serum SetLKJ · Traditional | Consolidated Technologies, Inc. | 09/27/1996SE |
| K954891 | Hytec Autoimmune Kits (Ss-B)LKJ · Traditional | Hycor Biomedical, Inc. | 12/26/1995SE |
| K954392 | Hytec Autoimmune Kit (Ss-A)LKJ · Traditional | Hycor Biomedical, Inc. | 12/26/1995SE |
| K954723 | Enzyme Immunoassay Ana Screening Test KitLKJ · Traditional | Helix Diagnostics, Inc. | 12/15/1995SE |
| K954700 | Enzyme Immunoassay Lupus Screen Test KitLKJ · Traditional | Helix Diagnostics, Inc. | 12/15/1995SE |
| K932876 | Diastat Anti-Nuclear Antibody (Ana) KitLKJ · Traditional | Shield Diagnostics, Ltd. | 11/15/1993SE |
| K931255 | Synelisa Cenp-B AntibodiesLKJ · Traditional | Elias U.S.A., Inc. | 09/24/1993SE |
| K932679 | Rheumelisa II Histone Antibody Test KitLKJ · Traditional | Biowhittaker Molecular Applications, Inc. | 08/23/1993SE |
| K932302 | Sylnelisa Histone AntibodiesLKJ · Traditional | Elias U.S.A., Inc. | 08/23/1993SE |
| K921132 | Syn Elisa Dsdna AntibodiesLKJ · Traditional | Elias U.S.A., Inc. | 12/01/1992SE |
| K914454 | The Theratest El-Ana ProfilesLKJ · Traditional | Theratest Laboratories, Inc. | 05/22/1992SE |
| K913342 | Autostat(Tm) Anti-DsnaLKJ · Traditional | Cogent Diagnotics , Ltd. | 05/01/1992SE |
| K920150 | Encore SCL-70LKJ · Traditional | Clark Laboratories, Inc. | 03/18/1992SE |
| K914550 | Antinuclear Antibody Immunoglobulin Test SystemLKJ · Traditional | Diagnostic Resources, Inc. | 02/11/1992SE |
| K912291 | Distat ANTI-SCL-70 KitLKJ · Traditional | Shield Diagnostics, Ltd. | 07/30/1991SE |
| K894411 | Seratest Ena [SCL-70] KitLKJ · Traditional | Hemagen Diagnostics, Inc. | 08/02/1989SE |
| K893896 | Quantitative Assay for Det. of Igg Igm Anti-DsdnaLKJ · Traditional | Biostar Medical Products, Inc. | 07/14/1989SE |
| K893897 | Semi-Quantitative Assay for Det. of Igg and IgmLKJ · Traditional | Biostar Medical Products, Inc. | 06/23/1989SE |
| K885224 | ANA-5 Autoantibody Profile KitLKJ · Traditional | Autoimmunity Diagnostics Corp. | 04/14/1989SE |
| K883949 | Antinuclear Antibody (Ana) Test (Mouse Liver Sect)LKJ · Traditional | Immco Diagnostics, Inc. | 10/27/1988SE |
| K883883 | Antinuclear Antibody (Ana) Test (HEP-2 Cells)LKJ · Traditional | Immco Diagnostics, Inc. | 10/27/1988SE |
| K882740 | Access R-Clone(Tm) Ana/Rf Screening AssayLKJ · Traditional | Lipogen, Inc. | 09/22/1988SE |
| K874115 | No. 1000-H for Immunofluorometric Deter. of (Ana)LKJ · Traditional | Sigma Diagnostics, Inc. | 11/04/1987SE |
| K873249 | Antinuclear Antibody (Ana) Positive ControlsLKJ · Traditional | Cytotech, Inc. | 09/22/1987SE |
| K864668 | Ana Test KitLKJ · Traditional | Val Tech Diagnostics, Inc. | 03/12/1987SE |
| K862313 | Kallestad Sm/Rnp Test ReagentLKJ · Traditional | Kallestad Laboratories, Inc. | 08/06/1986SE |
| K842563 | Seratest DNA DeterminationLKJ · Traditional | Seragen Diagnostics, Inc. | 10/25/1984SE |
| K842484 | Leap Le Test KitLKJ · Traditional | Cooper Biomedical, Inc. | 07/11/1984SE |
| K831463 | Ana-CheckLKJ · Traditional | Diagnostic Technology, Inc. | 06/08/1983SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0082-2022 Class II | BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent…A new lot of ANA screen control and any subsequent control lots are incompatible with older lot numbers of… | Bio-Rad Laboratories, Inc. | 11/01/2019Terminated |
| Z-2627-2017 Class III | DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear…FANA200 kit lot TS 3577 was re-worked due to shortened shelf-life. The alert sticker on the kit box of the… | Euro Diagnostica AB | 05/22/2017Terminated |
| Z-0306-2018 Class II | Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear…Euro Diagnostica has identified a deviation in one of the components of the DIASTAT ANA (FANA200), lot TS… | Euro Diagnostica AB | 02/14/2017Terminated |
| Z-2922-2018 Class III | is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA)…Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. | Euro Diagnostica AB | 10/21/2016Terminated |
| Z-0929-2018 Class II | DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200.…Complaint investigation concluded that although product quality requirements stated in the instructions for… | Euro Diagnostica AB | 10/15/2015Terminated |
| Z-0612-2011 | Bio-Rad Laboratories Autoimmune EIA ANA Screening kit, 96 test, model 96AN, Distributed…Product mislabeled-- the ANA cutoff Control and Prostiva controls were mislabeled. Use of the incorrect… | Bio-Rad Laboratories Inc | 06/24/2010Terminated |
| Z-1479-2011 | Bio Rad brand Autoimmune EIA ANA Screening Kit, 96 Tests, Catalog No. 96AN-BPU-TRINITY.…The firm received customer complaints of increased positivity rates associated with the ANA Screening kit… | Bio-Rad Laboratories Inc | 03/01/2010Terminated |
| Z-1478-2011 | DiaSorin ETI-ANA Screen Kit, 96 Test, Model Number N0093, manufactured by Bio-Rad…Inaccurate results-- Consumer complaints of increased positivity rates with the ANA screening kit. | Bio-Rad Laboratories Inc | 03/01/2010Terminated |
| Z-0540-2011 | Autoimmune EIA ANA Screening Test Kit, 576 Tests, Model/Catalog Number: 576AN…The ANA Screening kit generates a high percentage of false positive results, associated with a low check… | Bio-Rad Laboratories Inc | 03/01/2010Terminated |
| Z-0539-2011 | Autoimmune EIA ANA Screening Test Kit, 96 Tests, Model/Catalog Number: 96AN manufactured…The ANA Screening kit generates a high percentage of false positive results, associated with a low check… | Bio-Rad Laboratories Inc | 03/01/2010Terminated |
| Z-0608-2011 | Quest EIA ANA Screen Bulk Kit, model number 96AN-BPU-QUEST. Manufactured by Bio-Rad…The value for the ANA Cutoff and ANA Positive Controls will decrease overtime resulting in an unusually… | Bio-Rad Laboratories Inc | 02/26/2010Terminated |
| Z-0613-2011 | Bio-Rad brand Meridian ANA Screen ELISA Test Kit, 96 Test, Catalog No. 4884261…False positive test results caused by decrease in the OD values of ANA Cutoff Controls and ANA Positive… | Bio-Rad Laboratories Inc | 02/24/2010Terminated |
| Z-1159-2008 | BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM: a) 100 test - Catalog No. 665-1150; and b)…False negative results due to reagent packs exhibiting low signal. | Bio-Rad Laboratories | 11/13/2007Terminated |