FDA product code OIU: Test, Epithelial Ovarian Tumor Associated Antigen (He4)
OIU is the FDA product code for test, epithelial ovarian tumor associated antigen (he4). It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel. FDA has cleared 5 510(k) submissions under OIU, from 2 different applicants. The average 510(k) review took 218 days (median 215).
Definition
An enzyme immunometric assay for the quantitative determination of HE4 in human serum. The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer. It is not intended to estimate or assess the risk of disease outcomes of patients.
Classification
| Field | Value |
|---|---|
| Device name | Test, Epithelial Ovarian Tumor Associated Antigen (He4) |
| Device class | Class II |
| Regulation | 21 CFR 866.6010 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every OIU clearance
Top OIU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fujirebio Diagnostics,Inc. | 4 | 2015-11-24 |
| Roche Diagnostics | 1 | 2012-09-10 |
Most recent OIU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K151378 | Fujirebio Diagnostics,Inc. | Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators | 2015-11-24 | 186 |
| K112624 | Roche Diagnostics | ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5 | 2012-09-10 | 368 |
| K103676 | Fujirebio Diagnostics,Inc. | FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL | 2011-07-19 | 215 |
| K093957 | Fujirebio Diagnostics,Inc. | ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01, | 2010-03-18 | 85 |
| K072939 | Fujirebio Diagnostics,Inc. | HE4 EIA, MODEL: 404-10 US | 2008-06-09 | 236 |
Recalls for OIU devices
openFDA lists no recalls for product code OIU.
Frequently asked questions
What is FDA product code OIU?
OIU is the FDA product code for test, epithelial ovarian tumor associated antigen (he4). It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel.
What device class is OIU?
Class II, regulation 21 CFR 866.6010. Typical premarket route: 510(k).
How long does a 510(k) take for product code OIU?
Across 5 cleared submissions the average was 218 days from receipt to decision (median 215).
Which companies have the most OIU clearances?
Fujirebio Diagnostics,Inc. (4); Roche Diagnostics (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OIU
- Run a recall and safety report across every OIU manufacturer
- Watch product code OIU 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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