FDA product code OIC: Blood Alcohol Kit (Excludes Hiv Testing)
OIC is the FDA product code for blood alcohol kit (excludes hiv testing). It is a Class II device, regulated under 21 CFR 862.3040 and reviewed by the Clinical Chemistry panel. Devices under OIC reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Blood Alcohol Kit (Excludes Hiv Testing) |
| Device class | Class II |
| Regulation | 21 CFR 862.3040 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) exempt |
Recalls for OIC devices
openFDA lists no recalls for product code OIC.
Frequently asked questions
What is FDA product code OIC?
OIC is the FDA product code for blood alcohol kit (excludes hiv testing). It is a Class II device, regulated under 21 CFR 862.3040 and reviewed by the Clinical Chemistry panel.
What device class is OIC?
Class II, regulation 21 CFR 862.3040. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OIC
- Run a recall and safety report across every OIC manufacturer
- Watch product code OIC 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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