Product code PTJ— Microbiology

NG-Test CARBA 5

Classification name: Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Total cleared: 3
First cleared: 2017-04-27
Most recent: 2025-06-04

FDA classification definition

“Qualitative detection of carbapenemase enzymes in pure colonies of Enterobacteriaceae and Pseudomonas aeruginosa that have elevated MIC values to any Carbapenem”
— U.S. Food and Drug Administration, device classification record for product code PTJ under 21 CFR 866.1640, via openFDA

Market context for product code PTJ

FDA has cleared 3 devices under product code PTJ between 2017 and 2025, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20251 clearance
20191 clearance
20171 clearance

Top applicants under product code PTJ

Ng Biotech2 clearances
Biomerieux S.A.1 clearance

Recent clearances under product code PTJ

K243499 — NG-Test® CTX-M MULTINg Biotech·2025-06-04
K191889 — NG-Test CARBA 5Ng Biotech·2019-10-02
K162385 — RAPIDEC CARBA NPBiomerieux S.A.·2017-04-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.