Company · US
Cepheid
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2026. Name variants (Inc, Corp, punctuation) are merged.
65510(k) clearances (7 in 12 months)
19recalls (3 in 12 months)
15recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NQX | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | 14 |
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | 8 |
| NJR | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | 7 |
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | 7 |
| LSL | Dna-Reagents, Neisseria | 5 |
| PGX | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | 4 |
| OYX | Bcr/Abl1 Monitoring Test | 3 |
| PEU | System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen | 3 |
| POC | System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen | 3 |
| PQA | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System | 3 |
| NIJ | System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species | 2 |
| NPR | Test, Factor Ii G20210a Mutations, Genomic Dna Pcr | 2 |
| OPU | 2 | |
| OQW | 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification | 2 |
| OUY | Trichomonas Vaginalis Nucleic Acid Amplification Test System | 2 |
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | 2 |
| QQX | Respiratory Specimen Nucleic Acid Sars-Cov-2 Test | 2 |
| JSM | Culture Media, Non-Propagating Transport | 1 |
| LLH | Reagents, Clostridium Difficile Toxin | 1 |
| N/A | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 22, 2026 | K263333 | Xpert Xpress CoV-2/Flu plus Cepheid® | QOF |
| Oct 2, 2026 | K263120 | Xpert Xpress CoV-2/Flu plus Cepheid® | QOF |
| Sep 25, 2026 | K261336 | Xpert Respiratory Panel Cepheid | QOF |
| Aug 7, 2026 | K261362 | Xpert Hemorrhagic Fever Cepheid | QVR |
| Jul 2, 2026 | K261867 | Xpert Carba-R Cepheid® | POC |
| Feb 20, 2026 | K253653 | Xpert Hemorrhagic Fever Cepheid | |
| Jan 16, 2026 | K251721 | Xpert GI Panel Cepheid | PCH |
| May 1, 2025 | K250996 | Xpert Xpress CoV-2/Flu/RSV plus Cepheid® | QOF |
| May 1, 2025 | K250995 | Xpert Xpress CoV-2/Flu/RSV plus Cepheid® | QOF |
| Feb 28, 2025 | K243730 | Xpert C. difficile/Epi Cepheid® | OZN |
| Feb 21, 2025 | K250218 | Xpert® FII & FV Cepheid | NPR |
| Jan 15, 2025 | K242109 | Xpert® Xpress CoV-2 plus (XPRS-COV2-10) Cepheid® | QQX |
| Jan 10, 2025 | K242071 | Xpert Xpress CoV-2/Flu/RSV plus Cepheid | QOF |
| Dec 18, 2024 | K243625 | Xpert MRSA/SA SSTI Cepheid® | NQX |
| Nov 21, 2024 | K243405 | Xpert vanA Cepheid® | NIJ |
| Oct 25, 2024 | K243070 | Xpert® SA Nasal Complete Cepheid® | NQX |
| Jun 27, 2024 | DEN240016 | Xpert HCV; GeneXpert Xpress System Cepheid | SBP |
| Oct 19, 2023 | K231381 | Xpert Xpress MVP; GeneXpert Xpress System Cepheid | PQA |
| Oct 13, 2023 | K230440 | Xpert® Xpress CoV-2 plus Cepheid® | QQX |
| Sep 27, 2023 | K222638 | Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems Cepheid | NJR |
| Aug 17, 2023 | K231481 | Xpert Xpress CoV-2/Flu/RSV plus Cepheid® | QOF |
| Feb 15, 2023 | K223046 | Xpert® FII & FV Cepheid® | NPR |
| Jun 7, 2022 | K221160 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System Cepheid | PQA |
| May 9, 2022 | K203429 | Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System Cepheid | NJR |
| Feb 9, 2022 | K212213 | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System Cepheid | PQA |
| Sep 27, 2019 | K190076 | Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems Cepheid | OYX |
| May 23, 2019 | K190441 | Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System Cepheid | QEP |
| Apr 25, 2019 | K190771 | Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System Cepheid | NQX |
| Aug 15, 2018 | K181289 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (G Cepheid | OCC |
| Jul 24, 2018 | K180218 | Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II Cepheid | OCC |
| Apr 26, 2018 | K173398 | Xpert Xpress Strep A Cepheid | PGX |
| Mar 16, 2018 | K173840 | Xpert CT/NG Cepheid | LSL |
| Jan 9, 2018 | K173263 | Xpert Carba-R Cepheid | POC |
| Dec 19, 2017 | K171552 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, Ge Cepheid | OCC |
| Sep 25, 2017 | K172126 | Xpert Xpress Strep A Cepheid | PGX |
| Feb 13, 2017 | K162456 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpe Cepheid | OCC |
| Feb 9, 2017 | K162331 | Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), Gen Cepheid | OCC |
| Nov 23, 2016 | K162444 | Xpert MRSA NxG Cepheid | NQX |
| Aug 29, 2016 | K161619 | Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Cepheid | OUY |
| Jun 29, 2016 | K160901 | Xpert Carba-R Cepheid | POC |
| Mar 7, 2016 | K152614 | Xpert Carba-R Cepheid | PMY |
| Dec 3, 2015 | K151226 | Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) Cepheid | OCC |
| Oct 16, 2015 | K151565 | Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s Cepheid | OUY |
| Feb 12, 2015 | K143302 | Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 Cepheid | PEU |
| Nov 26, 2014 | K142501 | Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s Cepheid | PCH |
| Nov 22, 2014 | K142045 | XPERT FLU/RSV XC ASSAY Cepheid | OCC |
| Jul 25, 2013 | DEN130032 | XPERT MTB/RIF ASSAY Cepheid | PEU |
| Jun 20, 2013 | K130894 | XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE Cepheid | NQX |
| Dec 27, 2012 | K121710 | XPERT CT/NG Cepheid | LSL |
| Dec 21, 2012 | K123191 | XPERT FLU Cepheid | OCC |
Newest 50 of 65.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2025 | Cepheid Brand Name: Xpert BCR-ABL Ultra
Model/Catalog Number: GXBCRABL-10 Open, Classified |
OYX | None listed |
| Dec 18, 2025 | Cepheid Brand Name: Xpert BCR-ABL Ultra
Model/Catalog Number: GXBCRABL-US-10 Open, Classified |
OYX | K190076 |
| Nov 26, 2025 | Cepheid Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. Open, Classified |
PEU | K143302 |
| Oct 30, 2025 | Cepheid Xpert SA Nasal Complete
Catalog Number: GXSACOMP-10
UDI-DI code: 07332940000158
Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used f Open, Classified |
NQX | K100822 K243070 |
| Aug 14, 2024 | Cepheid Cepheid, Sample Collection Device, Part: 900-0370 Open, Classified |
JSM | K946283 |
| Nov 2, 2023 | Cepheid Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD, Open, Classified |
PGX | K172126 |
| Nov 2, 2023 | Cepheid Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only Open, Classified |
PGX | K172126 |
| Oct 9, 2017 | Cepheid Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT/NG-10 Batch 1000056157.
Is a qualitative in vitro real-time Terminated |
LSL | K121710 |
| Sep 15, 2017 | Cepheid Xpert EV Assay, Catalog GXEV-100N-10.
The Cepheid Xpert EV assay is a reverse transcription polymerase chain reaction (RT-PCR) using the GeneXpert Dx System for the presumptive qualitative detectio Terminated |
N/A | None listed |
| Jul 18, 2016 | Cepheid Xpert MRSA
Catalog GXMRSA-120, Rev. AJ
Microbiology:
The Cepheid Xpert MRSA assay performed in the GeneXpert Dx System
(Xpert MRSA) is a qualitative in vitro diagnostic test designed for rapid detec Terminated |
NQX | K070462 |
| Aug 20, 2015 | Cepheid Xpert CT/NG Urine Specimen Collection Kit
Part number GXCT/NGURINE-50;
Microbiology: Xpert CT/NG Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis and Neisseri Terminated |
LSL | K121710 |
| Aug 20, 2015 | Cepheid Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit:
Part number CT/NGSWAB-50;
Microbiology: The Cepheid X pert CT /NG Vagina Endocervical/ Specimen Collection Kit is designed to collect, pres Terminated |
LSL | K121710 |
| Jan 11, 2012 | Cepheid Cepheid brand Xpert MRSA/SA-BC US-IVD, an In-vitro diagnostic test kit, Catalog Numbers: GXMRSA/SA-BC-10, Lots Affected: 2803 and 3001; Terminated |
NQX | K082140 K101879 |
| May 31, 2011 | Cepheid Xpert Infinity Software, V 4.1a.
Cepheid, Sunnyvale, CA 94089
system software for GeneXpert Infinity 48 Terminated |
NJR | K103766 |
| Jul 1, 2010 | Cepheid Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx System, manufactured by Cepheid, Sunnyvale, CA.
Medical device, qualitative in vitro diagnostic test intended for the detection Terminated |
NQX | K082140 |
| May 25, 2010 | Cepheid Cepheid Xpert Flu A Panel (GXFLUPANEL-CE-10), manufactured by Cepheid, Sunnyvale, CA.
Indicated as an automated multiplex real-time RT-PCR assay for use in labroatories for the in vitro qualitative Terminated |
OPU | None listed |
| May 25, 2010 | Cepheid Cepheid Xpert Flu A Panel (GXFLUPANEL-10), manufactured by Cepheid, Sunnyvale, CA.
Indicated as an automated multiplex real-time RT-PCR assay for use in labroatories for the in vitro qualitative det Terminated |
OPU | None listed |
| Jan 12, 2008 | Cepheid Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for use with the GeneXpert DX System, Cepheid, Sunnyvale, CA 94089 Terminated |
NJR | K060540 |
| Aug 17, 2005 | Cepheid SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler Terminated |
NSR | K033415 |