PTJ — Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates Class II

FDA Device Classification

Classification Details

Product Code: PTJ
Device Class: Class II
Regulation Number: 866.1640
Submission Type
Review Panel: MI
Medical Specialty: Microbiology
Implant: No

Definition

Qualitative detection of carbapenemase enzymes in pure colonies of Enterobacteriaceae and Pseudomonas aeruginosa that have elevated MIC values to any Carbapenem

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K243499	ng biotech	NG-Test® CTX-M MULTI	June 4, 2025
K191889	ng biotech	NG-Test CARBA 5	October 2, 2019
K162385	biomerieux	RAPIDEC CARBA NP	April 27, 2017