Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV— 510(k) K171552

Name: FDA 510(k) clearance K171552
Creator: U.S. Food and Drug Administration
Published: 2017-12-19

Substantially Equivalent

Cepheid

FDA 510(k) clearance K171552 for Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV, Substantially Equivalent on 2017-12-19. Applicant: Cepheid. Device class: 2.

Clearance details

Applicant: Cepheid
Product code: Code OCC
Device class: Class 2
Regulation: 21 CFR 866.3980
Advisory panel: Microbiology
Date received: 2017-05-26
Decision date: 2017-12-19
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OCC

view all

K262747 — ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.02026-08-31
K254139 — BioCode® Respiratory Pathogen Panel (RPP)2026-05-01
K242613 — NxTAG® Respiratory Pathogen Panel2024-10-02
K232775 — ID NOW Influenza A & B 22023-10-10
K231017 — Panther Fusion AdV/hMPV/RV Assay2023-05-05

More clearances from Cepheid

view all

K261362 — Xpert Hemorrhagic Fever2026-08-07
K261867 — Xpert Carba-R2026-07-02
K253653 — Xpert Hemorrhagic Fever2026-02-20
K251721 — Xpert GI Panel2026-01-16
K250995 — Xpert Xpress CoV-2/Flu/RSV plus2025-05-01

Adverse events under product code OCC

product code OCC

Death: 3
Malfunction: 706
Total: 709

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.