FDA product code ORH: Lamotrigine Assay
ORH is the FDA product code for lamotrigine assay. It is a Class II device, regulated under 21 CFR 862.3350 and reviewed by the Clinical Toxicology panel. FDA has cleared 2 510(k) submissions under ORH, from 2 different applicants. The average 510(k) review took 138 days (median 138).
Definition
for the quantitative determination of lamotrigine in human serum or plasma on automated clinical chemistry analyzers.
Classification
| Field | Value |
|---|---|
| Device name | Lamotrigine Assay |
| Device class | Class II |
| Regulation | 21 CFR 862.3350 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Top ORH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ark Diagnostics, Inc. | 1 | 2010-10-29 |
| Seradyn, Inc. | 1 | 2007-01-12 |
Most recent ORH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K101305 | Ark Diagnostics, Inc. | ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL | 2010-10-29 | 172 |
| K062966 | Seradyn, Inc. | QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS | 2007-01-12 | 105 |
Recalls for ORH devices
openFDA lists no recalls for product code ORH.
Frequently asked questions
What is FDA product code ORH?
ORH is the FDA product code for lamotrigine assay. It is a Class II device, regulated under 21 CFR 862.3350 and reviewed by the Clinical Toxicology panel.
What device class is ORH?
Class II, regulation 21 CFR 862.3350. Typical premarket route: 510(k).
How long does a 510(k) take for product code ORH?
Across 2 cleared submissions the average was 138 days from receipt to decision (median 138).
Which companies have the most ORH clearances?
Ark Diagnostics, Inc. (1); Seradyn, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ORH
- Run a recall and safety report across every ORH manufacturer
- Watch product code ORH 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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