FDA product code OAH: Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
OAH is the FDA product code for fish (fluorescent in situ hybridization) kit, protein nucleic acid, enterococcus faecalis. It is a Class I device, regulated under 21 CFR 866.3740 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under OAH. The average 510(k) review took 194 days (median 212). FDA has posted 1 recall for OAH devices.
Definition
E. Faecalis pna fish is a qualitative nucleic acid hybridization assay intended for the identification of enterococcus faecalis and other enterococci (oe) from blood cultures showing Gram-positive cocci in pairs and chains.
Classification
| Field | Value |
|---|---|
| Device name | Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis |
| Device class | Class I |
| Regulation | 21 CFR 866.3740 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every OAH clearance
Top OAH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Advandx, Inc. | 4 | 2013-01-07 |
Most recent OAH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K121991 | Advandx, Inc. | ENTEROCOCCUS QUICKFISH BC | 2013-01-07 | 185 |
| K083074 | Advandx, Inc. | AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT | 2009-07-24 | 282 |
| K082612 | Advandx, Inc. | GBS PNA FISH | 2009-05-05 | 238 |
| K063127 | Advandx, Inc. | ENTEROCOCCUS FAECALIS PNA FISH | 2006-12-22 | 70 |
Recalls for OAH devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-06-08.
Frequently asked questions
What is FDA product code OAH?
OAH is the FDA product code for fish (fluorescent in situ hybridization) kit, protein nucleic acid, enterococcus faecalis. It is a Class I device, regulated under 21 CFR 866.3740 and reviewed by the Microbiology panel.
What device class is OAH?
Class I, regulation 21 CFR 866.3740. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code OAH?
Across 4 cleared submissions the average was 194 days from receipt to decision (median 212).
Which companies have the most OAH clearances?
Advandx, Inc. (4).
Have OAH devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2010-06-08.
Next steps
- Run an FDA pathway report with predicate devices for product code OAH
- Run a recall and safety report across every OAH manufacturer
- Watch product code OAH 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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