Enzyme Immunoassay, N-Acetylprocainamide
Enzyme immunoassay for N-acetylprocainamide is a laboratory test system used in clinical toxicology to measure serum levels of N-acetylprocainamide, an active metabolite of the antiarrhythmic drug procainamide, for therapeutic drug monitoring. It is classified as FDA Class 2, indicating moderate risk and the requirement for 510(k) premarket clearance. The product code is LAN, regulated under 21 CFR 862.3320, in the Clinical Toxicology specialty. Third-party review is available for this device.
Basic Information
- Product Code
- LAN
- Device Class
- FDA class 2
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 21 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K060738 | TDM N-ACETYLPROCAINAMIDE | Aug 16, 2006 | Substantially Equivalent | ROCHE DIAGNOSTICS CORP. |
| K032564 | DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111 | Oct 31, 2003 | Substantially Equivalent | DADE BEHRING, INC. |
| K011620 | EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229 | Jun 18, 2001 | Substantially Equivalent | SYVA CO., DADE BEHRING, INC. |
| K983812 | NAPA EIA ASSAY | Nov 16, 1998 | Substantially Equivalent | DIAGNOSTIC REAGENTS, INC. |
| K971713 | N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | Jun 11, 1997 | Substantially Equivalent | BAYER CORP. |
| K955422 | AXSYM N-ACETYLPROCAINAMIDE | Apr 24, 1996 | Substantially Equivalent | ABBOTT LABORATORIES |
| K934705 | OPUS NAPA | Nov 22, 1993 | Substantially Equivalent | PB DIAGNOSTIC SYSTEMS, INC. |
| K922915 | EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT | Aug 24, 1992 | Substantially Equivalent | SYVA CO. |
| K895571 | N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT | Oct 25, 1989 | Substantially Equivalent | TUDOR LABORATORIES, INC. |
| K873349 | EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649 | Sep 22, 1987 | Substantially Equivalent | EM DIAGNOSTIC SYSTEMS, INC. |
| K871680 | MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR | Jun 08, 1987 | Substantially Equivalent | ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K860140 | STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO. | Feb 06, 1986 | Substantially Equivalent | AMERICAN DADE |
| K853547 | STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I | Sep 16, 1985 | Substantially Equivalent | AMERICAN DADE |
| K852319 | COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORS | Jun 25, 1985 | Substantially Equivalent | ROCHE DIAGNOSTIC SYSTEMS, INC. |
| K851060 | EMIT QST N-ACETYLPROCAINAMIDE ASSAY | Apr 05, 1985 | Substantially Equivalent | SYVA CO. |
| K833378 | N-ACETYLPROCAINAMIDE ACA-ANALYTICAL | Dec 27, 1983 | Substantially Equivalent | E.I. DUPONT DE NEMOURS & CO., INC. |
| K832098 | N-ACETYLPROCAINAMIDE ASSAY FOR COBAS | Aug 12, 1983 | Substantially Equivalent | SYVA CO. |
| K831399 | AMES TDA N-ACETYL-PROCAINAMIDE TEST | Jun 02, 1983 | Substantially Equivalent | MILES LABORATORIES, INC. |
| K830206 | TDX N-ACETYLPROCAINAMIDE | Feb 18, 1983 | Substantially Equivalent | ABBOTT LABORATORIES |
| K823129 | ADVANCE EMIT-CAD N-ACETYLPROCAINAMIDE | Nov 29, 1982 | Substantially Equivalent | SYVA CO. |
| K781378 | EMIT N-ACETYLPROCAINAMIDE ASSAY | Oct 10, 1978 | Substantially Equivalent | SYVA CO. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.