FDA product code OSL: Control, Fecal Occult Blood
OSL is the FDA product code for control, fecal occult blood. It is a Class II device, regulated under 21 CFR 864.6550 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under OSL. The average 510(k) review took 92 days (median 92).
Definition
Fecal occult blood controls (Negative and positive) are used to verify the performance of the fecal occult blood test devices.
Classification
| Field | Value |
|---|---|
| Device name | Control, Fecal Occult Blood |
| Device class | Class II |
| Regulation | 21 CFR 864.6550 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every OSL clearance
Top OSL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bionostics, Inc. | 1 | 2010-10-01 |
Most recent OSL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K101831 | Bionostics, Inc. | ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800 | 2010-10-01 | 92 |
Recalls for OSL devices
openFDA lists no recalls for product code OSL.
Frequently asked questions
What is FDA product code OSL?
OSL is the FDA product code for control, fecal occult blood. It is a Class II device, regulated under 21 CFR 864.6550 and reviewed by the Hematology panel.
What device class is OSL?
Class II, regulation 21 CFR 864.6550. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code OSL?
Across 1 cleared submissions the average was 92 days from receipt to decision (median 92).
Which companies have the most OSL clearances?
Bionostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OSL
- Run a recall and safety report across every OSL manufacturer
- Watch product code OSL 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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