FDA product code OUS: Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt
OUS is the FDA product code for methicillin resistant staphylococcus aureus/methicillin susceptible staphylococcus aureus blood culture test bt. It is a Class I device, regulated under 21 CFR 866.2050 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under OUS. The average 510(k) review took 148 days (median 148).
Definition
The mrsa/mssa blood culture test-bt is a qualitative ivd test using bacteriophage amplification for the identification of staphylococcus aureus and the determination of meca mediated methicillin resistance or methicillin susceptbility directly from positive blood cultures confirmed to have gram positive cocci in clusters (gpcc) or gram positive cocci in singles (gpc) by gram stain.
Classification
| Field | Value |
|---|---|
| Device name | Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt |
| Device class | Class I |
| Regulation | 21 CFR 866.2050 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every OUS clearance
Top OUS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Microphage, Inc. | 2 | 2012-03-30 |
Most recent OUS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K120563 | Microphage, Inc. | KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT | 2012-03-30 | 35 |
| K102342 | Microphage, Inc. | KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT | 2011-05-05 | 260 |
Recalls for OUS devices
openFDA lists no recalls for product code OUS.
Frequently asked questions
What is FDA product code OUS?
OUS is the FDA product code for methicillin resistant staphylococcus aureus/methicillin susceptible staphylococcus aureus blood culture test bt. It is a Class I device, regulated under 21 CFR 866.2050 and reviewed by the Microbiology panel.
What device class is OUS?
Class I, regulation 21 CFR 866.2050. Typical premarket route: 510(k).
How long does a 510(k) take for product code OUS?
Across 2 cleared submissions the average was 148 days from receipt to decision (median 148).
Which companies have the most OUS clearances?
Microphage, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code OUS
- Run a recall and safety report across every OUS manufacturer
- Watch product code OUS 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.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times