FDA product code LAR: Enzyme Immunoassay, Procainamide
LAR is the FDA product code for enzyme immunoassay, procainamide. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel. FDA has cleared 25 510(k) submissions under LAR, from 15 different applicants. The average 510(k) review took 70 days (median 49).
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Procainamide |
| Device class | Class II |
| Regulation | 21 CFR 862.3320 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LAR clearance
Top LAR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 8 | 1992-08-24 |
| Boehringer Mannheim Corp. | 2 | 1996-10-29 |
| Abbott Laboratories | 2 | 1996-04-02 |
| Roche Diagnostic Systems, Inc. | 2 | 1994-12-02 |
| Roche Diagnostics Corp. | 1 | 2006-08-23 |
10 more applicants have LAR clearances. See the full list in Caduvo.
Most recent LAR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K060773 | Roche Diagnostics Corp. | ONLINE TDM PROCAINAMIDE | 2006-08-23 | 154 |
| K032573 | Dade Behring, Inc. | DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110 | 2003-10-31 | 72 |
| K010812 | Syva Co., Dade Behring, Inc. | EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229 | 2001-04-13 | 25 |
| K971716 | Bayer Corp. | PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | 1997-06-27 | 49 |
| K963306 | Boehringer Mannheim Corp. | CEDIA N-ACETYLPROCAINAMIDE ASSAY | 1996-10-29 | 68 |
Recalls for LAR devices
openFDA lists no recalls for product code LAR.
Frequently asked questions
What is FDA product code LAR?
LAR is the FDA product code for enzyme immunoassay, procainamide. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel.
What device class is LAR?
Class II, regulation 21 CFR 862.3320. Typical premarket route: 510(k).
How long does a 510(k) take for product code LAR?
Across 25 cleared submissions the average was 70 days from receipt to decision (median 49).
Which companies have the most LAR clearances?
Syva Co. (8); Boehringer Mannheim Corp. (2); Abbott Laboratories (2); Roche Diagnostic Systems, Inc. (2); Roche Diagnostics Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LAR
- Run a recall and safety report across every LAR manufacturer
- Watch product code LAR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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