510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN240016Unknown

Xpert HCV; GeneXpert Xpress System

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

DEN240016 is the FDA 510(k) clearance record for Xpert HCV; GeneXpert Xpress System, a class II device, cleared for Cepheid on under FDA product code SBP (Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test). FDA's definition for product code SBP reads: "A simple point-of-care nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) test is an in vitro diagnostic device that is intended for prescription use for the detection of HCV RNA in clinical specimens as an aid in the...". FDA records list 62 510(k) clearances for Cepheid, from to . As of , FDA records show no recalls naming DEN240016.

Clearance record

Decision date
Received
(72 days to decision)
Product code
SBP Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test
Regulation
21 CFR 866.3171
Device class
Class II
Review panel
Microbiology
Applicant
Cepheid 904 Caribbean Dr., Sunnyvale CA
Third party review
No

Clearances, product code SBP

Trailing 12 months

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

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