510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221160Substantially Equivalent

Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System

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

K221160 is the FDA 510(k) clearance record for Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System, a class II device, cleared for Cepheid on under FDA product code PQA (Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System). FDA's definition for product code PQA reads: "A vaginitis and bacterial vaginosis nucleic acid detection system is a qualitative in vitro diagnostic device for the direct detection of nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis. The...". FDA records list 62 510(k) clearances for Cepheid, from to . As of , FDA records show no recalls naming K221160.

Clearance record

Decision date
Received
(47 days to decision)
Product code
PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Regulation
21 CFR 866.3975
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 PQA

Trailing 12 months
1 clearance under product code PQA in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PQA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260