FDA product code ORI: Levetiracetam Assay
ORI is the FDA product code for levetiracetam 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 ORI, 1 in the last five years. The average 510(k) review took 170 days (median 170); 193 days on average over the last three years.
Definition
For the quantitative determination of levetiracetam in human serum or plasma.
Classification
| Field | Value |
|---|---|
| Device name | Levetiracetam 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 |
510(k) clearances per year for ORI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 193 |
Top ORI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ark Diagnostics, Inc. | 2 | 2024-02-27 |
Most recent ORI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232522 | Ark Diagnostics, Inc. | ARK Levetiracetam II Assay | 2024-02-27 | 193 |
| K091653 | Ark Diagnostics, Inc. | ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00 | 2009-11-02 | 146 |
Recalls for ORI devices
openFDA lists no recalls for product code ORI.
Frequently asked questions
What is FDA product code ORI?
ORI is the FDA product code for levetiracetam assay. It is a Class II device, regulated under 21 CFR 862.3350 and reviewed by the Clinical Toxicology panel.
What device class is ORI?
Class II, regulation 21 CFR 862.3350. Typical premarket route: 510(k).
How long does a 510(k) take for product code ORI?
Across 2 cleared submissions the average was 170 days from receipt to decision (median 170).
Which companies have the most ORI clearances?
Ark Diagnostics, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code ORI
- Run a recall and safety report across every ORI manufacturer
- Watch product code ORI 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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