Enzyme Immunoassay, N-Acetylprocainamide
FDA product code LAN · Class II (moderate risk) · 21 CFR 862.3320 · Clinical Toxicology
21510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Syva Co. 5
- Abbott Laboratories 2
- Roche Diagnostic Systems, Inc. 2
- American Dade 2
- Miles Laboratories, Inc. 1
- E.I. Dupont DE Nemours & Co., Inc. 1
- Em Diagnostic Systems, Inc. 1
- Tudor Laboratories, Inc. 1
- Pb Diagnostic Systems, Inc. 1
- Bayer Corp. 1
- Diagnostic Reagents, Inc. 1
- Syva Co., Dade Behring, Inc. 1
- Dade Behring, Inc. 1
- Roche Diagnostics Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K060738 | TDM N-AcetylprocainamideLAN · Traditional | Roche Diagnostics Corp. | 08/16/2006SE |
| K032564 | Dimension N-Acetylprocainamide (Napa) Flex Reagent Cartridge Method, Model DF111LAN · Traditional | Dade Behring, Inc. | 10/31/2003SE |
| K011620 | Emit 2000 N-Acetylprocainamide Assay, Model OSR4N229LAN · Special | Syva Co., Dade Behring, Inc. | 06/18/2001SE |
| K983812 | Napa Eia AssayLAN · Traditional | Diagnostic Reagents, Inc. | 11/16/1998SE |
| K971713 | N-Acetylprocainamide Assay for the Bayer Immuno 1 SystemLAN · Traditional | Bayer Corp. | 06/11/1997SE |
| K955422 | Axsym N-AcetylprocainamideLAN · Traditional | Abbott Laboratories | 04/24/1996SE |
| K934705 | Opus NapaLAN · Traditional | Pb Diagnostic Systems, Inc. | 11/22/1993SE |
| K922915 | Emit 2000 N-Acetylprocainamide Assay and CalibratLAN · Traditional | Syva Co. | 08/24/1992SE |
| K895571 | N-Acetylprocainamide (Napa) (Fpia) KitLAN · Traditional | Tudor Laboratories, Inc. | 10/25/1989SE |
| K873349 | Easy-Test Emit N-Acetylprocainamide Napa #16649LAN · Traditional | Em Diagnostic Systems, Inc. | 09/22/1987SE |
| K871680 | Modified Cobas FP Reagents for Napa and CalibratorLAN · Traditional | Roche Diagnostic Systems, Inc. | 06/08/1987SE |
| K860140 | Stratus N-Ace (Napa) Fluorometric Enzyme/Immuno.LAN · Traditional | American Dade | 02/06/1986SE |
| K853547 | Stratus N-Acetylprocainamide Fluorometric Enzyme ILAN · Traditional | American Dade | 09/16/1985SE |
| K852319 | Cobas FP Reagents for Napa and Napa CalibratorsLAN · Traditional | Roche Diagnostic Systems, Inc. | 06/25/1985SE |
| K851060 | Emit QST N-Acetylprocainamide AssayLAN · Traditional | Syva Co. | 04/05/1985SE |
| K833378 | N-Acetylprocainamide Aca-AnalyticalLAN · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 12/27/1983SE |
| K832098 | N-Acetylprocainamide Assay for CobasLAN · Traditional | Syva Co. | 08/12/1983SE |
| K831399 | Ames Tda N-Acetyl-Procainamide TestLAN · Traditional | Miles Laboratories, Inc. | 06/02/1983SE |
| K830206 | TDX N-AcetylprocainamideLAN · Traditional | Abbott Laboratories | 02/18/1983SE |
| K823129 | Advance Emit-Cad N-AcetylprocainamideLAN · Traditional | Syva Co. | 11/29/1982SE |
| K781378 | Emit N-Acetylprocainamide AssayLAN · Traditional | Syva Co. | 10/10/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2386-2010 | ONLINE TDM N-acetylprocainamide, Part number 04642520190 N- acetylprocainamide reagent…The N-acetylprocainamide reagent lot 14456200 shows an incorrect expiration date of 7/31/2011. The correct… | Roche Diagnostics Operations, Inc. | 02/05/2010Terminated |