System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
FDA product code NQX · Class II (moderate risk) · 21 CFR 866.1640 · Microbiology
A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of MRSA colonization status for the prevention and control of MRSA infections in healthcare settings.
24510(k) clearances
0PMA approvals
20recalls
Manufacturers
- Cepheid 10
- Infectio Diagnostic (I.D.I.), Inc. 2
- Bd Diagnostics (Geneohm Sciences Canada, Inc) 2
- Roche Molecular Systems, Inc. 2
- BD Diagnostics (GeneOhm Sciences, Inc) 1
- Biomerieux Inc 1
- Nanosphere, Inc. 1
- Elitech 1
- Elitechgroup Epoch Biosciences 1
- Geneohm Sciences Canada, Inc. (Bd Diagnostics) 1
- Geneohm Sciences Canada, Inc. 1
- Luminex Corporation 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243625 | Xpert MRSA/SA SSTINQX · Special | Cepheid® | 12/18/2024SE |
| K243070 | Xpert® SA Nasal CompleteNQX · Special | Cepheid® | 10/25/2024SE |
| K191742 | ARIES MRSA AssayNQX · Traditional | Luminex Corporation | 09/25/2019SE |
| K190771 | Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System…NQX · Special | Cepheid | 04/25/2019SE |
| K162444 | Xpert MRSA NxGNQX · Traditional | Cepheid | 11/23/2016SE |
| K142721 | cobas MRSA/SA TestNQX · Traditional | Roche Molecular Systems, Inc. | 12/17/2014SE |
| K133605 | BD Max Mrsa XT, BD Max InstrumentNQX · Traditional | Geneohm Sciences Canada, Inc. | 12/20/2013SE |
| K132822 | BD Max Staphsr Assay, InstrumentNQX · Traditional | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 11/26/2013SE |
| K132468 | Mrsa/Sa Elite MGB, Elite MGB SoftwareNQX · Traditional | Elitechgroup Epoch Biosciences | 10/17/2013SE |
| K130894 | Xpert Mrsa/Sa Blood Culture Assay; Genexpert DX Systems (Gx-I, Gx-Ii, Gx-Iv, Gx-Xvi)…NQX · Traditional | Cepheid | 06/20/2013SE |
| K120138 | BD Max Mrsa Assay, BD Max InstrumentNQX · Traditional | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 07/05/2012SE |
| K112937 | Mrsa/Sa Elite MGBNQX · Traditional | Elitech | 06/01/2012SE |
| K112424 | Verigene Staphylococcus Blood Culture Nucleic Acid Test (Bc-S)NQX · Traditional | Nanosphere, Inc. | 12/16/2011SE |
| K102740 | Nuclisens Easyq Mrsa; Nuclisens Easyq Analyzer; Nuclisens Easyq Incubator (110 Volt)…NQX · Traditional | bioMerieux, Inc. | 05/20/2011SE |
| K101879 | Xpert Mrsa/Sa BC (Blood Culture) Assay Model GXMRSA/SA-BC-10NQX · Special | Cepheid | 07/28/2010SE |
| K091409 | Lightcycler Mrsa Advanced Test for Use with the Lightcycler 2.0 Instrument, Model 05205727NQX · Traditional | Roche Molecular Systems, Inc. | 07/06/2010SE |
| K100822 | Xpert Mrsa/Sa Nasal AssayNQX · Traditional | Cepheid | 06/01/2010SE |
| K093346 | BD Geneohm Mrsa Acp AssayNQX · Traditional | Bd Diagnostics (Geneohm Sciences, Inc.) | 12/15/2009SE |
| K082140 | Xpert Mrsa/Sa Blood Culture AssayNQX · Traditional | Cepheid | 09/29/2008SE |
| K080837 | Xpert Mrsa/Sa Ssti AssayNQX · Traditional | Cepheid | 09/24/2008SE |
| K071026 | BD Geneohm Staphsr AssayNQX · Traditional | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 12/20/2007SE |
| K070462 | Xpert MrsaNQX · Traditional | Cepheid | 04/17/2007SE |
| K042357 | Idi-Mrsa AssayNQX · Special | Infectio Diagnostic (I.D.I.), Inc. | 10/22/2004SE |
| K033415 | Idi-MrsaNQX · Traditional | Infectio Diagnostic (I.D.I.), Inc. | 03/18/2004SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0414-2026 Class II | Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA…As a result of Post-Market half-time stability testing, false negative test result was observed for a… | Cepheid | 08/06/2025Open, Classified |
| Z-2334-2019 Class II | Kit BD Max MRSA XT; Catalog # 443461The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | Becton Dickinson & Co. | 07/17/2019Terminated |
| Z-2333-2019 Class II | Kit BD Max StaphSR; Catalog # 443419The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | Becton Dickinson & Co. | 07/17/2019Terminated |
| Z-2332-2019 Class II | Kit BD Max StaphSR; Catalog # 443418The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | Becton Dickinson & Co. | 07/17/2019Terminated |
| Z-2328-2019 Class II | Kit BD Max MRSA; Catalog # 442953The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. | Becton Dickinson & Co. | 07/17/2019Terminated |
| Z-1195-2018 Class II | Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro…The cobas MRSA/SA tests may have decreased performance compared to the analytical sensitivity for MSRA… | Roche Molecular Systems, Inc. | 10/27/2017Terminated |
| Z-2548-2016 Class II | Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay…Internal investigation found the certain lots of MRSA kits have the potential for performance issues at… | Cepheid | 07/18/2016Terminated |
| Z-2618-2014 Class II | The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic…The performance of the assay no longer conforms to this statement in the Analytical Specificity section of… | Becton Dickinson & Co. | 07/23/2014Terminated |
| Z-2317-2012 Class II | BD GeneOhm MRSA ACP Assay, Catalog #441639, box 200 tests labeled in part***GeneOhm…Leakage in Cepheid SmartCycler reaction tubes. | Becton Dickinson & Co. | 05/22/2012Terminated |
| Z-0453-2012 | Cepheid brand Xpert MRSA/SA-BC US-IVD, an In-vitro diagnostic test kit, Catalog Numbers:…Cepheid has received reports from some of its customers regarding higher than desired (>5%) rates of invalid… | Cepheid | 11/17/2011Terminated |
| Z-3220-2011 | BD MAX GBS Catalog Number 441772 For In Vitro Diagnostic Use, For use with the BD MAX…Medical device bar code reader does not function as intended and could result in associating clinical test… | Becton Dickinson & Co. | 05/24/2011Terminated |
| Z-3219-2011 | BD MAX RNA Extraction Kit RNA-3, Catalog Number 437506. Kit contains 24/2D barcode…Sample results maybe switched between time it was scanned with handheld barcode reader and time it was… | Becton Dickinson & Co. | 05/24/2011Terminated |
| Z-3218-2011 | BD MAX DNA Extraction Kit DNA-3 (Swabs in Transport Medium/UTM), Catalog Number 437503.…Sample results maybe switched between time it was scanned with handheld barcode reader and time it was… | Becton Dickinson & Co. | 05/24/2011Terminated |
| Z-3217-2011 | BD MAX DNA Extraction Kit DNA-2 (Whole Blood) Catalog Number 437502. Kit contains 24/2D…Sample results maybe switched between time it was scanned with handheld barcode reader and time it was… | Becton Dickinson & Co. | 05/24/2011Terminated |
| Z-3216-2011 | BD MAX DNA Extraction Kit DNA-1 (Urine/Plasma) Catalog Number 437501. Kit contains 24/2D…Sample results maybe switched between time it was scanned with handheld barcode reader and time it was… | Becton Dickinson & Co. | 05/24/2011Terminated |
| Z-1898-2010 | Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx System…The firm is receiving reports of inaccurate results, which may result in delay of care for seriously ill… | Cepheid | 04/05/2010Terminated |
| Z-1963-2009 | BD Diagnostics, BD GeneOhm MRSA Assay, REF: 441242 (200 Reaction Kit) and 441244 (48…BD Diagnostics GeneOhm (BDDG) has determined that the Cepheid SmartCycler reaction tubes packaged in the BD… | BD Diagnostics (GeneOhm Sciences, Inc) | 11/11/2008Terminated |
| Z-0226-2009 | BD GeneOhm MRSA 48 ct, Catalog #441244. IDI-MRSA assay is a qualitative in vitro…BD Diagnostics GeneOhm (BDDG) initiated the recall after they identified that the product has the potential… | BD Diagnostics (GeneOhm Sciences, Inc) | 07/21/2008Terminated |
| Z-0225-2009 | BD GeneOhm MRSA 200 ct, Catalog #441242. IDI-MRSA assay is a qualitative in vitro…BD Diagnostics GeneOhm (BDDG) initiated the recall after they identified that the product has the potential… | BD Diagnostics (GeneOhm Sciences, Inc) | 07/21/2008Terminated |
| Z-0189-2007 | Doc-U-Dose Prescription Management System, Item 8-PKIT. The product is packaged and…The poly film may separate along the sealed seams of the packets of the Doc-U-Dose Prescription Management… | Eatonform Inc | 09/28/2006Terminated |