Ana Screen Elisa (Igg)
FDA 510(k) K131185 · Euroimmun US
510(k) numberK131185
Submission
- Device name
- Ana Screen Elisa (Igg)
- Applicant
- Euroimmun US
Morris Plains, NJ, US - Received
- April 26, 2013
- Decision date
- July 15, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
Other 510(k)s with product code LJM
| 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 |
| 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 |
More from Aesku, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K193115 | EUROIMMUN Anti-BP230-CF ELISA (IgG)OEG · Traditional | 09/17/2020SE |
| K183313 | EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue…MVM · Traditional | 02/28/2019SE |
| K172582 | EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic…MOB · Traditional | 05/24/2018SE |
| K172252 | EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternKTL · Traditional | 04/20/2018SE |
| K172244 | EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPatternKTL · Traditional | 04/20/2018SE |
| K172722 | Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)LSR · Traditional | 12/10/2017SE |
| K161513 | Anti-Borrelia burgdorferi US Westernblot (IgG)LSR · Traditional | 08/25/2016SE |
| K153308 | EUROIMMUN Anti-West Nile Virus ELISA (IgM)NOP · Traditional | 08/12/2016SE |
| K153303 | EUROIMMUN Anti-West Nile Virus ELISA (IgG)NOP · Traditional | 08/10/2016SE |
| K142038 | EUROIMMUN LYME ELISA(IgG/IgM)LSR · Traditional | 05/04/2015SE |
Questions and answers
When was Ana Screen Elisa (Igg) cleared by the FDA?
Ana Screen Elisa (Igg) (K131185) received a 510(k) decision of Substantially Equivalent on July 15, 2013, 80 days after the submission was received.
What is the product code of K131185?
The FDA product code is LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, a Class II (moderate risk) device regulated under 21 CFR 866.5100.