Cleared Special

Xpert vanA

K243405 · Cepheid · Microbiology
Nov 2024
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K243405 is an FDA 510(k) clearance for the Xpert vanA, a System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species (Class II — Special Controls, product code NIJ), submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on November 21, 2024, 20 days after receiving the submission on November 1, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K243405 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2024
Decision Date November 21, 2024
Days to Decision 20 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code NIJ — System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640
Definition The In Vitro Device Is Intended To Detect The Presence Of The Vana And Vanb Genes In Isolated Colonies Of Enterococcus Spp. As A Marker For Vancomycin Resistance Using Dna Probe Technology