FDA product code POC: System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
POC is the FDA product code for system, nucleic acid amplification test, dna, antimicrobial resistance marker, direct specimen. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under POC, 1 in the last five years, from 3 different applicants. The average 510(k) review took 94 days (median 90); 28 days on average over the last three years.
Definition
To detect the presence of genetic markers of antimicrobial resistance by testing directly from clinical specimens using nucleic acid amplification technology.
Classification
| Field | Value |
|---|---|
| Device name | System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen |
| 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 POC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 90 |
| 2019 | 1 | 171 |
| 2026 | 1 | 28 |
Compare with all 510(k) review times · Search every POC clearance
Top POC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cepheid | 2 | 2018-01-09 |
| Cepheid® | 1 | 2026-07-02 |
| Check-Points Health B.V. | 1 | 2019-08-29 |
Most recent POC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261867 | Cepheid® | Xpert Carba-R | 2026-07-02 | 28 |
| K190613 | Check-Points Health B.V. | BD MAX Check-Points CPO | 2019-08-29 | 171 |
| K173263 | Cepheid | Xpert Carba-R | 2018-01-09 | 90 |
| K160901 | Cepheid | Xpert Carba-R | 2016-06-29 | 89 |
Recalls for POC devices
openFDA lists no recalls for product code POC.
Frequently asked questions
What is FDA product code POC?
POC is the FDA product code for system, nucleic acid amplification test, dna, antimicrobial resistance marker, direct specimen. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel.
What device class is POC?
Class II, regulation 21 CFR 866.1640. Typical premarket route: 510(k).
How long does a 510(k) take for product code POC?
Across 4 cleared submissions the average was 94 days from receipt to decision (median 90).
Which companies have the most POC clearances?
Cepheid (2); Cepheid® (1); Check-Points Health B.V. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code POC
- Run a recall and safety report across every POC manufacturer
- Watch product code POC 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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