FDA product code PTJ: Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates
PTJ is the FDA product code for phenotypic test kit, non-susceptible/elevated mic organisms, cultured isolates. 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 PTJ, 1 in the last five years, from 2 different applicants. The average 510(k) review took 176 days (median 204); 204 days on average over the last three years. FDA has posted 1 recall for PTJ devices.
Definition
Qualitative detection of carbapenemase enzymes in pure colonies of Enterobacteriaceae and Pseudomonas aeruginosa that have elevated MIC values to any Carbapenem
Classification
| Field | Value |
|---|---|
| Device name | Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates |
| 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 PTJ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 245 |
| 2019 | 1 | 79 |
| 2025 | 1 | 204 |
Compare with all 510(k) review times · Search every PTJ clearance
Top PTJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ng Biotech | 2 | 2025-06-04 |
| Biomerieux S.A. | 1 | 2017-04-27 |
Most recent PTJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243499 | Ng Biotech | NG-Test® CTX-M MULTI | 2025-06-04 | 204 |
| K191889 | Ng Biotech | NG-Test CARBA 5 | 2019-10-02 | 79 |
| K162385 | Biomerieux S.A. | RAPIDEC CARBA NP | 2017-04-27 | 245 |
Recalls for PTJ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-05-16.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code PTJ?
PTJ is the FDA product code for phenotypic test kit, non-susceptible/elevated mic organisms, cultured isolates. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel.
What device class is PTJ?
Class II, regulation 21 CFR 866.1640. Typical premarket route: 510(k).
How long does a 510(k) take for product code PTJ?
Across 3 cleared submissions the average was 176 days from receipt to decision (median 204).
Which companies have the most PTJ clearances?
Ng Biotech (2); Biomerieux S.A. (1).
Have PTJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-05-16.
Next steps
- Run an FDA pathway report with predicate devices for product code PTJ
- Run a recall and safety report across every PTJ manufacturer
- Watch product code PTJ 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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