POC — System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen Class II

FDA Device Classification

Classification Details

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

Definition

To detect the presence of genetic markers of antimicrobial resistance by testing directly from clinical specimens using nucleic acid amplification technology.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K190613	check-points health	BD MAX Check-Points CPO	August 29, 2019
K173263	cepheid	Xpert Carba-R	January 9, 2018
K160901	cepheid	Xpert Carba-R	June 29, 2016