510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243405Substantially Equivalent

Xpert vanA

Cepheid, Sunnyvale CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243405 is the FDA 510(k) clearance record for Xpert vanA, a class II device, cleared for Cepheid® on under FDA product code NIJ (System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species). FDA's definition for product code NIJ reads: "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". FDA records list 62 510(k) clearances for Cepheid®, from to . As of , FDA records show no recalls naming K243405.

Clearance record

Decision date
Received
(20 days to decision)
Product code
NIJ System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
Regulation
21 CFR 866.1640
Device class
Class II
Review panel
Microbiology
Applicant
Cepheid® 904 Caribbean Dr., Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NIJ

Trailing 12 months

FDA records hold no clearances under product code NIJ in the trailing twelve months.

FDA records show no clearances under product code NIJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NIJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260