FDA product code MYI: System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
MYI is the FDA product code for system, test, genotypic detection, resistant markers, staphylococcus colonies. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel. FDA has cleared 10 510(k) submissions under MYI, from 7 different applicants. The average 510(k) review took 203 days (median 232).
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies |
| Device class | Class II |
| Regulation | 21 CFR 866.1640 |
| 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 MYI clearance
Top MYI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alere Scarborough, Inc. | 2 | 2014-09-03 |
| Binax, Inc. | 2 | 2010-04-14 |
| Id Biomedical Corp. | 2 | 2001-05-24 |
| Advandx, Inc. | 1 | 2014-10-10 |
| Mast Group , Ltd. | 1 | 2006-10-18 |
2 more applicants have MYI clearances. See the full list in Caduvo.
Most recent MYI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K140619 | Advandx, Inc. | MECA XPRESSFISH | 2014-10-10 | 213 |
| K133851 | Alere Scarborough, Inc. | ALERE PBP2A SA/CONS CULTURE COLONY TEST | 2014-09-03 | 258 |
| K121905 | Alere Scarborough, Inc. | ALERE PBP2A TEST | 2012-07-26 | 27 |
| K090301 | Binax, Inc. | BINAXNOW PBP2A TEST, MODEL 890-000 | 2010-04-14 | 432 |
| K091766 | Binax, Inc. | CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 | 2010-02-24 | 252 |
Recalls for MYI devices
openFDA lists no recalls for product code MYI.
Frequently asked questions
What is FDA product code MYI?
MYI is the FDA product code for system, test, genotypic detection, resistant markers, staphylococcus colonies. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel.
What device class is MYI?
Class II, regulation 21 CFR 866.1640. Typical premarket route: 510(k).
How long does a 510(k) take for product code MYI?
Across 10 cleared submissions the average was 203 days from receipt to decision (median 232).
Which companies have the most MYI clearances?
Alere Scarborough, Inc. (2); Binax, Inc. (2); Id Biomedical Corp. (2); Advandx, Inc. (1); Mast Group , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MYI
- Run a recall and safety report across every MYI manufacturer
- Watch product code MYI 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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