FDA product code OAV: Mycophenolic Acid Test System
OAV is the FDA product code for mycophenolic acid test system. It is a Class II device, regulated under 21 CFR 862.3840 and reviewed by the Clinical Toxicology panel. FDA has cleared 3 510(k) submissions under OAV, from 3 different applicants. The average 510(k) review took 237 days (median 247).
Definition
An in vitro diagnostic reagent system intended for use in the quantitative determination of total mycophenolic acid in human serum or plasma as an aid in the management of mycophenolic acid therapy in renal and cardiac transplant patients.
Classification
| Field | Value |
|---|---|
| Device name | Mycophenolic Acid Test System |
| Device class | Class II |
| Regulation | 21 CFR 862.3840 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every OAV clearance
Top OAV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Siemens Heatlhcare Diagnostics, Inc. | 1 | 2011-10-07 |
| Thermo Fisher Scientific | 1 | 2008-12-19 |
| Roche Diagnostics | 1 | 2007-02-16 |
Most recent OAV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K102772 | Siemens Heatlhcare Diagnostics, Inc. | DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL) | 2011-10-07 | 378 |
| K081083 | Thermo Fisher Scientific | CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS | 2008-12-19 | 247 |
| K063520 | Roche Diagnostics | ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS | 2007-02-16 | 87 |
Recalls for OAV devices
openFDA lists no recalls for product code OAV.
Frequently asked questions
What is FDA product code OAV?
OAV is the FDA product code for mycophenolic acid test system. It is a Class II device, regulated under 21 CFR 862.3840 and reviewed by the Clinical Toxicology panel.
What device class is OAV?
Class II, regulation 21 CFR 862.3840. Typical premarket route: 510(k).
How long does a 510(k) take for product code OAV?
Across 3 cleared submissions the average was 237 days from receipt to decision (median 247).
Which companies have the most OAV clearances?
Siemens Heatlhcare Diagnostics, Inc. (1); Thermo Fisher Scientific (1); Roche Diagnostics (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OAV
- Run a recall and safety report across every OAV manufacturer
- Watch product code OAV 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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