Cleared Traditional

Xpert VanA Assay

K092953 · Cepheid · Microbiology
Dec 2009
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K092953 is an FDA 510(k) clearance for the Xpert VanA Assay, 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 December 17, 2009, 84 days after receiving the submission on September 24, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K092953 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 2009
Decision Date December 17, 2009
Days to Decision 84 days
Submission Type Traditional
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