FDA product code OAU: Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma
OAU is the FDA product code for des-gamma-carboxy-prothrombin (dcp), risk assessment, hepatocellular carcinoma. It is a Class II device, regulated under 21 CFR 866.6030 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under OAU. The average 510(k) review took 170 days (median 170).
Definition
The test is intended to quantitatively measure dcp in human serum and use as an aid in the risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma (hcc) in conjunction with other laboratory findings, imaging studies and clinical assessment for risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma.
Classification
| Field | Value |
|---|---|
| Device name | Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma |
| Device class | Class II |
| Regulation | 21 CFR 866.6030 |
| 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 OAU clearance
Top OAU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wako Chemicals USA, Inc. | 1 | 2007-01-31 |
Most recent OAU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K062368 | Wako Chemicals USA, Inc. | WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401 | 2007-01-31 | 170 |
Recalls for OAU devices
openFDA lists no recalls for product code OAU.
Frequently asked questions
What is FDA product code OAU?
OAU is the FDA product code for des-gamma-carboxy-prothrombin (dcp), risk assessment, hepatocellular carcinoma. It is a Class II device, regulated under 21 CFR 866.6030 and reviewed by the Immunology panel.
What device class is OAU?
Class II, regulation 21 CFR 866.6030. Typical premarket route: 510(k).
How long does a 510(k) take for product code OAU?
Across 1 cleared submissions the average was 170 days from receipt to decision (median 170).
Which companies have the most OAU clearances?
Wako Chemicals USA, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OAU
- Run a recall and safety report across every OAU manufacturer
- Watch product code OAU 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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