510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K223046Substantially Equivalent

Xpert® FII & FV

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

K223046 is the FDA 510(k) clearance record for Xpert® FII & FV, a class II device, cleared for Cepheid® on under FDA product code NPR (Test, Factor Ii G20210a Mutations, Genomic Dna Pcr). FDA's definition for product code NPR reads: "In vitro diagnostic test to detect the Factor II G20210A mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia". FDA records list 62 510(k) clearances for Cepheid®, from to . As of , FDA records show no recalls naming K223046.

Clearance record

Decision date
Received
(139 days to decision)
Product code
NPR Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
Regulation
21 CFR 864.7280
Device class
Class II
Review panel
Hematology
Applicant
Cepheid® 904 Caribbean Dr., Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NPR

Trailing 12 months

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

FDA records show no clearances under product code NPR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NPR, 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