FDA product code PMY: System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
PMY is the FDA product code for system, nucleic acid amplification test, dna, carbapenem non-susceptible gram negative organism, colony. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under PMY, from 3 different applicants. The average 510(k) review took 379 days (median 175).
Definition
To detect the presence of genetic markers of antimicrobial resistance by testing isolated bacterial colonies using nucleic acid amplification technology.
Classification
| Field | Value |
|---|---|
| Device name | System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony |
| Device class | Class II |
| Regulation | 21 CFR 866.1640 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for PMY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 91 |
| 2021 | 1 | 871 |
Compare with all 510(k) review times · Search every PMY clearance
Top PMY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Opgen, Inc. | 1 | 2021-09-30 |
| Genepoc, Inc. | 1 | 2019-05-10 |
| Cepheid | 1 | 2016-03-07 |
Most recent PMY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K191288 | Opgen, Inc. | Acuitas AMR Gene Panel | 2021-09-30 | 871 |
| K190275 | Genepoc, Inc. | GenePOC Carba | 2019-05-10 | 91 |
| K152614 | Cepheid | Xpert Carba-R | 2016-03-07 | 175 |
Recalls for PMY devices
openFDA lists no recalls for product code PMY.
Frequently asked questions
What is FDA product code PMY?
PMY is the FDA product code for system, nucleic acid amplification test, dna, carbapenem non-susceptible gram negative organism, colony. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel.
What device class is PMY?
Class II, regulation 21 CFR 866.1640. Typical premarket route: 510(k).
How long does a 510(k) take for product code PMY?
Across 3 cleared submissions the average was 379 days from receipt to decision (median 175).
Which companies have the most PMY clearances?
Opgen, Inc. (1); Genepoc, Inc. (1); Cepheid (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PMY
- Run a recall and safety report across every PMY manufacturer
- Watch product code PMY 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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