510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN130032Unknown

Xpert Mtb/rif Assay

Cepheid, Sunnyvale CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN130032 is the FDA 510(k) clearance record for XPERT MTB/RIF ASSAY, a class II device, cleared for Cepheid on under FDA product code PEU (System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen). FDA's definition for product code PEU reads: "The [test] is intended for use with specimens from patients for whom there is clinical suspicion of tuberculosis (TB) and who have received no antituberculosis therapy, or less than 3 days of therapy. This [test] is intended as an aid in...". FDA records list 62 510(k) clearances for Cepheid, from to . As of , FDA records show no recalls naming DEN130032.

Clearance record

Decision date
Received
(44 days to decision)
Product code
PEU System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen
Regulation
21 CFR 866.3373
Device class
Class II
Review panel
Microbiology
Applicant
Cepheid 904 Caribbean Dr., Sunnyvale CA
Third party review
No

Clearances, product code PEU

Trailing 12 months

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

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