510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250996Substantially Equivalent

Xpert Xpress CoV-2/Flu/RSV plus

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

K250996 is the FDA 510(k) clearance record for Xpert Xpress CoV-2/Flu/RSV plus, a class II device, cleared for Cepheid® on under FDA product code QOF (Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents). FDA's definition for product code QOF reads: "A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device...". FDA records list 62 510(k) clearances for Cepheid®, from to . As of , FDA records show no recalls naming K250996.

Clearance record

Decision date
Received
(30 days to decision)
Product code
QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Regulation
21 CFR 866.3981
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 QOF

Trailing 12 months
7 clearances under product code QOF in the twelve months to October 2026, September 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code QOF, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20261
April 20260
May 20260
June 20261
July 20260
August 20260
September 20263
October 20260