FDA product code LEG: Enzyme Immunoassay, Valproic Acid
LEG is the FDA product code for enzyme immunoassay, valproic acid. It is a Class II device, regulated under 21 CFR 862.3645 and reviewed by the Clinical Toxicology panel. FDA has cleared 35 510(k) submissions under LEG, from 24 different applicants. The average 510(k) review took 80 days (median 60). FDA has posted 7 recalls for LEG devices.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Valproic Acid |
| Device class | Class II |
| Regulation | 21 CFR 862.3645 |
| 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 LEG clearance
Top LEG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 5 | 2001-07-02 |
| Roche Diagnostic Systems, Inc. | 3 | 1995-10-30 |
| Roche Diagnostics Corp. | 2 | 2006-08-08 |
| Dade Behring, Inc. | 2 | 2000-10-11 |
| Sigma Diagnostics, Inc. | 2 | 1997-07-30 |
19 more applicants have LEG clearances. See the full list in Caduvo.
Most recent LEG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K090358 | Abbott Laboratories, Inc. | ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35 | 2009-08-06 | 175 |
| K060690 | Roche Diagnostics Corp. | ONLINE VALPROIC ACID | 2006-08-08 | 146 |
| K042807 | Bayer Healthcare, LLC | ADVIA IMS VALPROIC ACID METHOD | 2005-02-08 | 119 |
| K042476 | Ortho-Clinical Diagnostics, Inc. | VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS | 2004-12-01 | 79 |
| K032049 | Roche Diagnostics Corp. | ROCHE ONLINE TDM VALPROIC ACID | 2003-08-22 | 51 |
Recalls for LEG devices
7 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-12-11.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code LEG?
LEG is the FDA product code for enzyme immunoassay, valproic acid. It is a Class II device, regulated under 21 CFR 862.3645 and reviewed by the Clinical Toxicology panel.
What device class is LEG?
Class II, regulation 21 CFR 862.3645. Typical premarket route: 510(k).
How long does a 510(k) take for product code LEG?
Across 35 cleared submissions the average was 80 days from receipt to decision (median 60).
Which companies have the most LEG clearances?
Syva Co. (5); Roche Diagnostic Systems, Inc. (3); Roche Diagnostics Corp. (2); Dade Behring, Inc. (2); Sigma Diagnostics, Inc. (2).
Have LEG devices been recalled?
Yes: 7 product recalls across 5 recall events; the most recent began 2018-12-11.
Next steps
- Run an FDA pathway report with predicate devices for product code LEG
- Run a recall and safety report across every LEG manufacturer
- Watch product code LEG 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.
All Clinical Toxicology product codes · FDA product code lookup · 510(k) database search · 510(k) review times