# Cepheid

- Location (FDA's records): Sunnyvale, CA
- FDA decisions: 65 (2006–2026): 62 510(k) clearances and 3 De Novo grants
- Names in FDA's records: Cepheid (52); Cepheid® (13)
- Product codes: NQX (10), OCC (8), QOF (7), NJR (5), PQA (3), POC (3), PGX (2), NPR (2), QQX (2), NIJ (2), PEU (2), LSL (2)
- 510(k) review time since 2016: median 91 days, against 136 for FDA's reviews in the same codes and years (8 of 17 faster)
- Predicates its devices cite: 88 (41 its own); citations of its devices by later devices: 56 (41 its own)
- Recalls linked to its devices: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Becton, Dickinson & CO: 7 (https://510kreport.com/company/becton-dickinson)
- Gen-Probe, Inc.: 4 (https://510kreport.com/company/gen-probe)
- Bd Diagnostics (Geneohm Sciences Canada, Inc): 3 (https://510kreport.com/company/bd-diagnostics-geneohm-sciences-canada)
- Copan Diagnostics, Inc.: 3 (https://510kreport.com/company/copan-diagnostics)
- Iquum, Inc.: 2 (https://510kreport.com/company/iquum)
- Geneohm Sciences Canada, Inc.: 2 (https://510kreport.com/company/geneohm-sciences-canada)
- Infectio Diagnostic, Inc.: 2 (https://510kreport.com/company/infectio-diagnostic)
- Wellcome Diagnostics: 2 (https://510kreport.com/company/wellcome-diagnostics)

## Firms that cite its devices most
- Meridian Bioscience, Inc.: 2 (https://510kreport.com/company/meridian-bioscience)
- Visby Medical, Inc.: 2 (https://510kreport.com/company/visby-medical)
- Opgen, Inc.: 1 (https://510kreport.com/company/opgen)
- Iquum, Inc.: 1 (https://510kreport.com/company/iquum)
- Bd Diagnostics (Geneohm Sciences, Inc.): 1 (https://510kreport.com/company/bd-diagnostics-geneohm-sciences)
- Handylab, Inc.: 1 (https://510kreport.com/company/handylab)
- Diagenode: 1 (https://510kreport.com/company/diagenode)
- R-Biopharm AG: 1 (https://510kreport.com/company/r-biopharm)

## Its most-cited devices
- K062948: Smart GBS and Smartcycle DX System and Software, Version 1.7B (2006), cited by 4
- K151226: Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) (2015), cited by 4
- K121710: Xpert CT/NG (2012), cited by 3
- K142045: Xpert Flu/RSV XC Assay (2014), cited by 3
- K152614: Xpert Carba-R (2016), cited by 3
- K242071: Xpert Xpress CoV-2/Flu/RSV plus (2025), cited by 2

## Recent decisions
- K263333: Xpert Xpress CoV-2/Flu plus (Oct 22, 2026)
- K263120: Xpert Xpress CoV-2/Flu plus (Oct 2, 2026)
- K261336: Xpert Respiratory Panel (Sep 25, 2026)
- K261362: Xpert Hemorrhagic Fever (Aug 7, 2026)
- K261867: Xpert Carba-R (Jul 2, 2026)
- K253653: Xpert Hemorrhagic Fever (Feb 20, 2026)
- K251721: Xpert GI Panel (Jan 16, 2026)
- K250996: Xpert Xpress CoV-2/Flu/RSV plus (May 1, 2025)

Source page: https://510kreport.com/company/cepheid