PTJ · Class II · 21 CFR 866.1640

FDA Product Code PTJ: Phenotypic Test Kit, Non-susceptible/elevated Mic Organisms, Cultured Isolates

Qualitative Detection Of Carbapenemase Enzymes In Pure Colonies Of Enterobacteriaceae And Pseudomonas Aeruginosa That Have Elevated Mic Values To Any Carbapenem

Leading manufacturers include Ng Biotech.

3
Total
3
Cleared
176d
Avg days
2017
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 204d recently vs 162d historically

FDA 510(k) Cleared Phenotypic Test Kit, Non-susceptible/elevated Mic Organisms, Cultured Isolates Devices (Product Code PTJ)

3 devices
1–3 of 3
Cleared Jun 04, 2025
NG-Test® CTX-M MULTI
K243499
Ng Biotech
Microbiology · 204d

About Product Code PTJ - Regulatory Context

510(k) Submission Activity

3 total 510(k) submissions under product code PTJ since 2017, with 3 receiving FDA clearance (average review time: 176 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under PTJ have taken an average of 204 days to reach a decision - up from 162 days historically. Manufacturers should account for longer review timelines in current project planning.

PTJ devices are reviewed by the Microbiology panel. Browse all Microbiology devices →