Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
FDA product code LJM · Class II (moderate risk) · 21 CFR 866.5100 · Immunology
112510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Elias U.S.A., Inc. 16
- Zeus Scientific, Inc. 6
- Theratest Laboratories, Inc. 6
- Biohytech International, Inc. 6
- American Laboratory Products Co., Ltd. 6
- Lipogen, Inc. 5
- David A. Fuccillo, Ph.D. 4
- Orgentec 4
- Rhigene, Inc. 3
- Helix Diagnostics, Inc. 3
- Micro Detect, Inc. 3
- Immco Diagnostics, Inc. 3
- Inova Diagnostics, Inc. 3
- Diamedix Corp. 2
- Phadia AB 2
- Pharmacia & Upjohn Co. 2
- Shield Diagnostics, Ltd. 2
- General Biometrics, Inc. 2
- Immuno-Products Industries 2
- Amico Lab, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K182353 | EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayLJM · Traditional | Phadia AB | 11/27/2018SE |
| K151559 | ImmuLisa Enhanced Centromere Antibody ELISALJM · Traditional | Immco Diagnostics, Inc. | 03/11/2016SE |
| K140493 | Elia SCL-70S ImmunoassayLJM · Traditional | Phadia GmbH | 10/30/2014SE |
| K123880 | Quanta Flash CentromereLJM · Traditional | Inova Diagnostics, Inc. | 02/07/2014SE |
| K131330 | Gold Standard Diagnostics Anti-Nuclear Antibody (Ana) Screen Elisa Test KitLJM · Traditional | Gold Standard Diagnostics | 01/28/2014SE |
| K131185 | Ana Screen Elisa (Igg)LJM · Traditional | Euroimmun US | 07/15/2013SE |
| K083188 | Varelisa Recombi Ana Screen, Model 12 596LJM · Traditional | Phadia US, Inc. | 03/13/2009SE |
| K050967 | Varelisa Recombi CTD Screen, Model 13096LJM · Traditional | Sweden Diagnostics (Germany) GmbH | 06/28/2005SE |
| K050625 | Varelisa Recombi Ana Profile, Model 18496LJM · Traditional | Sweden Diagnostics (Germany) GmbH | 04/26/2005SE |
| K041102 | Immulisa Antinuclear Antibody Screen ElisaLJM · Traditional | Immco Diagnostics, Inc. | 10/26/2004SE |
| K040953 | Aeskulisa Ana HEP-2LJM · Traditional | Aesku, Inc. | 06/23/2004SE |
| K040810 | Varelisa Histone Antibodies, Model 16496LJM · Traditional | Pharmacia Deutschland GmbH | 05/14/2004SE |
| K040291 | El-Ana Profiles: Anti-ChromatinLJM · Traditional | Theratest Laboratories, Inc. | 03/11/2004SE |
| K040200 | MESACUP-2 Test Cenp-BLJM · Traditional | Rhigene, Inc. | 03/04/2004SE |
| K030929 | Ana DetectLJM · Traditional | Orgentec Diagnostika GmbH | 05/02/2003SE |
| K024031 | The Theratest El-Ana Profiles: Anti-CentromereLJM · Traditional | Theratest Laboratories, Inc. | 02/06/2003SE |
| K022018 | Rhigene Ana Elisa Test System, Model K7560LJM · Special | Rhigene, Inc. | 07/05/2002SE |
| K004019 | Ana Eia Diagnostic Test KitLJM · Traditional | The Binding Site, Ltd. | 02/15/2001SE |
| K003959 | Quanta Lite Centromere (Cenp-A & Cenp-B) ElisaLJM · Traditional | Inova Diagnostics, Inc. | 01/22/2001SE |
| K002559 | El-Ana PROFILES-2K1LJM · Traditional | Theratest Laboratories, Inc. | 09/12/2000SE |
| K000880 | The Aptus (Automated Application of the Tpo Igg Elisa Test System. an Enzyme Linked…LJM · Traditional | Zeus Scientific, Inc. | 05/22/2000SE |
| K000879 | The Aptus (Automated) Application of the TG Igg Elisa Test System. an Enzyme Linked…LJM · Traditional | Zeus Scientific, Inc. | 05/22/2000SE |
| K000934 | Mdi SCL-70 TestLJM · Traditional | Micro Detect, Inc. | 04/07/2000SE |
| K994071 | Rhigene Ana Elisa Test SystemLJM · Traditional | Rhigene, Inc. | 01/18/2000SE |
| K993636 | Mdi Ss-A TestLJM · Traditional | Micro Detect, Inc. | 01/10/2000SE |
| K993635 | Mdi Sm/Rnp TestLJM · Traditional | Micro Detect, Inc. | 01/10/2000SE |
| K993109 | Varelisa Recombi Ana ProfileLJM · Traditional | Pharmacia & Upjohn Co. | 11/12/1999SE |
| K993108 | Varelisa Recombi Ana Screen Eia, Models 128 48/ 128 96LJM · Traditional | Pharmacia & Upjohn Co. | 11/12/1999SE |
| K992041 | Relisa Ana Screening Test System, Model 7096-11LJM · Traditional | Immuno Concepts, Inc. | 07/23/1999SE |
| K983655 | Autostat II Ana Screen ElisaLJM · Traditional | Cogent Diagnotics , Ltd. | 01/28/1999SE |
| K983378 | The Aptus (Automated) Application of the Ana Screen Elisa Test System. an Enzyme Linked…LJM · Traditional | Zeus Scientific, Inc. | 11/18/1998SE |
| K980810 | Seraquest Anti-SsaLJM · Traditional | Quest Intl., Inc. | 05/12/1998SE |
| K980337 | Diamedix Immunosimplicity Ana (Is-Ana) Screen Test SystemLJM · Traditional | Helix Diagnostics, Inc. | 05/12/1998SE |
| K964385 | Elias ANA-HEP-2LJM · Traditional | Elias U.S.A., Inc. | 03/06/1997SE |
| K962450 | Hy-Tec/Manual Autoimmune Kit for HistoneLJM · Traditional | Hycor Biomedical, Inc. | 11/25/1996SE |
| K962062 | Orgentec Anti-Sm ElisaLJM · Traditional | American Laboratory Products Co., Ltd. | 11/18/1996SE |
| K962057 | Orgentec Anti-Rnp/Sm ElisaLJM · Traditional | American Laboratory Products Co., Ltd. | 11/18/1996SE |
| K962055 | Orgentec Anti-Scl 70 ElisaLJM · Traditional | American Laboratory Products Co., Ltd. | 11/15/1996SE |
| K962054 | Orgentec Anti-Ss-A(Ro) ElisaLJM · Traditional | American Laboratory Products Co., Ltd. | 11/15/1996SE |
| K962053 | Orgentec ANTI-JO-1 ElisaLJM · Traditional | American Laboratory Products Co., Ltd. | 11/15/1996SE |
| K962052 | Orgentec Abti-Ss-Bb(La) ElisaLJM · Traditional | American Laboratory Products Co., Ltd. | 11/15/1996SE |
| K963291 | Varelisa Ana (4) ProfileLJM · Traditional | Elias U.S.A., Inc. | 09/30/1996SE |
| K954832 | Orgentec Anti-Ss-B(La) Pin Immuno AssayLJM · Traditional | Orgentec | 04/18/1996SE |
| K954829 | Orgentec ANTI-JO-1 Pin Immuno AssayLJM · Traditional | Orgentec | 04/18/1996SE |
| K954815 | Orgentec Anti-Ss-A(Ro) Pin Immuno AssayLJM · Traditional | Orgentec | 04/18/1996SE |
| K954814 | Orgentec Anti-Scl 70 Pin Immuno AssayLJM · Traditional | Orgentec | 04/18/1996SE |
| K955481 | Theratest Kit (Modification)LJM · Traditional | Theratest Laboratories, Inc. | 03/06/1996SE |
| K954380 | Quanta Lite SsdnaLJM · Traditional | Inova Diagnostics, Inc. | 02/29/1996SE |
| K952490 | Imagetiter Instrument, Ana Test Kit & Calibrator SerumLJM · Traditional | Roche Image Analysis Systems | 12/15/1995SE |
| K954106 | Theratest Lab, Inc., El-Anascr KitLJM · Traditional | Theratest Laboratories, Inc. | 11/14/1995SE |
| K950716 | Theratest El-Ana Profiles Test SystemLJM · Traditional | Theratest Laboratories, Inc. | 09/26/1995SE |
| K951850 | Enzyme Immunoassay ANTI-JO-1 Antibody Test KitLJM · Traditional | Helix Diagnostics, Inc. | 07/18/1995SE |
| K951798 | Enzyme Immunoassay ANTI-SCI-70 Antibody Test KitLJM · Traditional | Helix Diagnostics, Inc. | 07/17/1995SE |
| K950110 | Mardx Mitochondria Eia Test SystemLJM · Traditional | Hogan & Hartson | 05/15/1995SE |
| K946218 | Mardx Ena Eia Test SystemLJM · Traditional | Hogan & Hartson | 05/15/1995SE |
| K951207 | Varelisa Histone AntibodiesLJM · Traditional | Elias U.S.A., Inc. | 04/17/1995SE |
| K951205 | Varelisa Ana ProfileLJM · Traditional | Elias U.S.A., Inc. | 04/17/1995SE |
| K951186 | Varelisa ANA-4 ScreenLJM · Traditional | Elias U.S.A., Inc. | 04/17/1995SE |
| K943585 | Anti-Histone Anibody TestLJM · Traditional | Immco Diagnostics, Inc. | 01/20/1995SE |
| K944173 | Varelisa JO-1 AntibodiesLJM · Traditional | Elias U.S.A., Inc. | 12/22/1994SE |
| K944172 | Varelisa SCL-70 AntibodiesLJM · Traditional | Elias U.S.A., Inc. | 12/22/1994SE |
| K944171 | Varelisa Centromere AntibodiesLJM · Traditional | Elias U.S.A., Inc. | 12/22/1994SE |
| K944170 | Varelisa SM AntibodiesLJM · Traditional | Elias U.S.A., Inc. | 12/22/1994SE |
| K944169 | Varelisa Ro (Ss-A) AntibodiesLJM · Traditional | Elias U.S.A., Inc. | 12/22/1994SE |
| K944168 | Varelisa la (Ss-B) AntibodiesLJM · Traditional | Elias U.S.A., Inc. | 12/22/1994SE |
| K944167 | Varelisa Rnp-Sm AntibodiesLJM · Traditional | Elias U.S.A., Inc. | 12/22/1994SE |
| K941509 | Radias Ana Screen Enzyme ImmunoassayLJM · Traditional | Bio-Rad | 06/30/1994SE |
| K941409 | Ena PROFILE-6 Elisa Test SystemLJM · Traditional | Zeus Scientific, Inc. | 06/10/1994SE |
| K941014 | Ena Screen Elisa Test SystemLJM · Traditional | Zeus Scientific, Inc. | 06/10/1994SE |
| K940700 | Autozyme ScreenLJM · Traditional | Cambridge Life Sciences Plc. | 06/10/1994SE |
| K940253 | Histone Eia Test KitLJM · Traditional | David A. Fuccillo, Ph.D. | 05/02/1994SE |
| K935416 | Ro Eia Test KitLJM · Traditional | David A. Fuccillo, Ph.D. | 05/02/1994SE |
| K935415 | RNP Eia Test KitLJM · Traditional | David A. Fuccillo, Ph.D. | 05/02/1994SE |
| K935414 | SM Eia Test KitLJM · Traditional | David A. Fuccillo, Ph.D. | 05/02/1994SE |
| K940641 | Elias Ana TotalLJM · Traditional | Elias U.S.A., Inc. | 03/25/1994SE |
| K935468 | Synelisa Ana TotalLJM · Traditional | Elias U.S.A., Inc. | 03/25/1994SE |
| K933267 | Autoantibody PROFILE-6 Elisa Test SystemLJM · Traditional | Zeus Scientific, Inc. | 12/15/1993SE |
| K932206 | Synelisa Ana ProfileLJM · Traditional | Elias U.S.A., Inc. | 12/03/1993SE |
| K932424 | Ana Profile ILJM · Traditional | Apotex Scientific, Inc. | 08/10/1993SE |
| K930209 | Synelisa Ro Abs / la AbsLJM · Traditional | Elias U.S.A., Inc. | 06/11/1993SE |
| K924248 | Accutex Sle Latex TestLJM · Traditional | J.S. Medical Assoc. | 11/02/1992SE |
| K924087 | Kalestad Ana Microplate EiaLJM · Traditional | Bio-Rad Laboratories, Inc. | 11/02/1992SE |
| K920616 | Diastat Anti-Histone KitLJM · Traditional | Shield Diagnostics, Ltd. | 07/14/1992SE |
| K915272 | Hemagen Ena [Rnp/Sm] Kit (Eia Method)LJM · Traditional | Hemagen Diagnostics, Inc. | 03/17/1992SE |
| K914853 | Antinuclear Antibody (Ana) Screening Test KitLJM · Traditional | Reads Medical Products, Inc. | 01/15/1992SE |
| K910033 | Ubi Magiwel(Tm) Ana QuantitativeLJM · Traditional | United Biotech, Inc. | 01/25/1991SE |
| K905190 | Diastat Ena ProfileLJM · Traditional | Shield Diagnostics, Ltd. | 12/07/1990SE |
| K902915 | ANTI-SCI-70 MicroassayLJM · Traditional | Diamedix Corp. | 09/06/1990SE |
| K900072 | Immunodot Autoimmunity Screening Panel 2LJM · Traditional | General Biometrics, Inc. | 01/24/1990SE |
| K896347 | Immunodot Autoimmune Screening Panel 1LJM · Traditional | General Biometrics, Inc. | 12/05/1989SE |
| K895995 | Rheumelisa Assay for Ss-B/La AutoantibodiesLJM · Traditional | Lipogen, Inc. | 10/27/1989SE |
| K895994 | Rheumelisa Assay for Ss-A/Ro AutoantibodiesLJM · Traditional | Lipogen, Inc. | 10/24/1989SE |
| K894894 | Anti-Sm MicroassayLJM · Traditional | Diamedix Corp. | 08/24/1989SE |
| K892421 | Modified Access R-Clone Ana/Rf Screening TestLJM · Traditional | Lipogen, Inc. | 05/09/1989SE |
| K874195 | La Antibody Test KitLJM · Traditional | Lipogen, Inc. | 03/11/1988SE |
| K875246 | Lipogen Ana Test KitLJM · Traditional | Lipogen, Inc. | 02/10/1988SE |
| K872839 | Antinuclear Antibody TestLJM · Traditional | Cappel Diagnostics, Inc. | 10/20/1987SE |
| K870453 | Ds-Dna Eia Diagnostic KitLJM · Traditional | Biohytech International, Inc. | 03/24/1987SE |
| K870457 | RNP Eia Diagnostic KitLJM · Traditional | Biohytech International, Inc. | 03/17/1987SE |
| K870456 | DNP Eia Diagnostic KitLJM · Traditional | Biohytech International, Inc. | 03/17/1987SE |
| K870455 | SM Eia Diagnostic KitLJM · Traditional | Biohytech International, Inc. | 03/17/1987SE |
| K870452 | Ss-Dna Eia Diagnostic KitLJM · Traditional | Biohytech International, Inc. | 03/17/1987SE |
| K862969 | Ana-Enzyme Immunoassay (Ana-Eia) Diagnostic KitLJM · Traditional | Biohytech International, Inc. | 10/24/1986SE |
| K852840 | Enzyme Antinuclear Antibody Screening TestLJM · Traditional | Modern Diagnostics, Inc. | 08/01/1985SE |
| K852231 | ANA/LITE-HEP-2 Test SystemLJM · Traditional | Immuno-Products Industries | 07/10/1985SE |
| K852230 | Ana/Lite-Rl Test SystemLJM · Traditional | Immuno-Products Industries | 07/10/1985SE |
| K843904 | DNA Stat Test KitLJM · Traditional | Whittaker Bioproducts, Inc. | 11/01/1984SE |
| K843745 | Adp Ana ApplezymeLJM · Traditional | Apple Diagnostic Products | 10/25/1984SE |
| K842533 | Amizyme-Andna Test KitLJM · Traditional | Amico Lab, Inc. | 09/20/1984SE |
| K842532 | Amizyme-Ana Test KitLJM · Traditional | Amico Lab, Inc. | 09/20/1984SE |
| K833148 | Enzyme Ana Test SystemLJM · Traditional | Immuno Concepts, Inc. | 11/21/1983SE |
| K822346 | Histimune Enzyme-Ana TestLJM · Traditional | Icl Scientific | 10/08/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0981-2010 | ANA IgG ELISA 96 Well Kit, Catalog Number: AN033G The products in question are all…The recall was initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits.… | Calbiotech Inc | 08/27/2008Terminated |
| Z-1089-2009 | Sm ELISA Test System Product number 2Z2831G and Product number 43270CE Individual…The Calibrator Value is printed incorrectly on the Sm ELISA Test System, lot # 08041819. The Calibrator… | Zeus Scientific Inc | 08/19/2008Terminated |