Cleared Traditional

Xpert Carba-R

K152614 · Cepheid · Microbiology
Mar 2016
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K152614 is an FDA 510(k) clearance for the Xpert Carba-R, a System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-susceptible Gram Negative Organism, Colony (Class II — Special Controls, product code PMY), submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on March 7, 2016, 175 days after receiving the submission on September 14, 2015. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K152614 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2015
Decision Date March 07, 2016
Days to Decision 175 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code PMY — System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-susceptible Gram Negative Organism, Colony
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640
Definition To Detect The Presence Of Genetic Markers Of Antimicrobial Resistance By Testing Isolated Bacterial Colonies Using Nucleic Acid Amplification Technology.