FDA product code OTV: Research Use Only/Clinical Chemistry Devices
OTV is the FDA product code for research use only/clinical chemistry devices. It is a Not classified device, reviewed by the Clinical Chemistry panel. Devices under OTV reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
For research use only and for products imported into the US only.
Classification
| Field | Value |
|---|---|
| Device name | Research Use Only/Clinical Chemistry Devices |
| Device class | Not classified |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for OTV devices
openFDA lists no recalls for product code OTV.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- Q4240 — Corecyte, for topical use only, per 0.5 cc
- Q4241 — Polycyte, for topical use only, per 0.5 cc
Frequently asked questions
What is FDA product code OTV?
OTV is the FDA product code for research use only/clinical chemistry devices. It is a Not classified device, reviewed by the Clinical Chemistry panel.
What device class is OTV?
Not classified. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OTV
- Run a recall and safety report across every OTV manufacturer
- Watch product code OTV 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 Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times