Product code NQX
- Device name
- System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.1640
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243625 | Xpert MRSA/SA SSTI | Cepheid® | 2024-12-18 |
| K243070 | Xpert® SA Nasal Complete | Cepheid® | 2024-10-25 |
| K191742 | ARIES MRSA Assay | Luminex Corporation | 2019-09-25 |
| K190771 | Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System | Cepheid | 2019-04-25 |
| K162444 | Xpert MRSA NxG | Cepheid | 2016-11-23 |
| K142721 | cobas MRSA/SA Test | Roche Molecular Systems, Inc. | 2014-12-17 |
| K133605 | BD MAX MRSA XT, BD MAX INSTRUMENT | Geneohm Sciences Canada, Inc. | 2013-12-20 |
| K132822 | BD MAX STAPHSR ASSAY, INSTRUMENT | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2013-11-26 |
| K132468 | MRSA/SA ELITE MGB, ELITE MGB SOFTWARE | Elitechgroup Epoch Biosciences | 2013-10-17 |
| K130894 | XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE | Cepheid | 2013-06-20 |
| K120138 | BD MAX MRSA ASSAY, BD MAX INSTRUMENT | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2012-07-05 |
| K112937 | MRSA/SA ELITE MGB | Elitech | 2012-06-01 |
| K112424 | VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S) | Nanosphere, Inc. | 2011-12-16 |
| K102740 | NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EASYQ INCUBATOR (110 VOLT); NUCLISENS DIRECTOR V.2.6 | bioMerieux, Inc. | 2011-05-20 |
| K101879 | XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10 | Cepheid | 2010-07-28 |
| K091409 | LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727 | Roche Molecular Systems, Inc. | 2010-07-06 |
| K100822 | XPERT MRSA/SA NASAL ASSAY | Cepheid | 2010-06-01 |
| K093346 | BD GENEOHM MRSA ACP ASSAY | Bd Diagnostics (Geneohm Sciences, Inc.) | 2009-12-15 |
| K082140 | XPERT MRSA/SA BLOOD CULTURE ASSAY | Cepheid | 2008-09-29 |
| K080837 | XPERT MRSA/SA SSTI ASSAY | Cepheid | 2008-09-24 |
| K071026 | BD GENEOHM STAPHSR ASSAY | Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2007-12-20 |
| K070462 | XPERT MRSA | Cepheid | 2007-04-17 |
| K042357 | IDI-MRSA ASSAY | Infectio Diagnostic (I.D.I.), Inc. | 2004-10-22 |
| K033415 | IDI-MRSA | Infectio Diagnostic (I.D.I.), Inc. | 2004-03-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840487101575 | Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge | LUMINEX CORPORATION | 2019-12-05 |
| 00840487101629 | Gram-Positive Blood Culture (BC-GP) Extraction Tray | LUMINEX CORPORATION | 2019-12-05 |
| 00840487101674 | Gram-Positive Blood Culture (BC-GP) Utility Tray | LUMINEX CORPORATION | 2019-12-05 |
| 00840487101445 | ARIES® MRSA Assay | LUMINEX CORPORATION | 2019-10-08 |
| 07332940002442 | Xpert MRSA | CEPHEID | 2018-01-29 |
| 07332940001728 | Xpert MRSA NxG | CEPHEID | 2018-01-29 |
| 07332940001711 | Xpert MRSA NxG | CEPHEID | 2018-01-29 |
| 07332940000196 | Xpert MRSA | CEPHEID | 2018-01-29 |
| 07332940000141 | Xpert MRSA/SA Blood Culture | CEPHEID | 2018-01-29 |
| 07332940000158 | Xpert SA Nasal Complete | CEPHEID | 2018-01-29 |
| 07332940000165 | Xpert SA Nasal Complete | CEPHEID | 2018-01-29 |
| 07332940000189 | Xpert MRSA/SA SSTI | CEPHEID | 2018-01-29 |
| 00382904434618 | BD MAX™ MRSA XT | BECTON, DICKINSON AND COMPANY | 2017-04-12 |
| 00382904434199 | BD MAX™ StaphSR | BECTON, DICKINSON AND COMPANY | 2017-04-12 |
| 03661540950001 | MRSA/SA ELITe MGB | Elitechgroup Mdx LLC | 2016-10-13 |
| 00857573006119 | Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test Cartridge | NANOSPHERE, INC. | 2016-09-23 |
| 00857573006218 | Gram-Positive Blood Culture (BC-GP) Extraction Tray | NANOSPHERE, INC. | 2016-09-23 |
| 00857573006287 | Gram-Positive Blood Culture (BC-GP) Utility Tray | NANOSPHERE, INC. | 2016-09-23 |
| 00382904414481 | BD GeneOhm™ StaphSR assay 48 TestsA | Geneohm Sciences Canada Inc | 2016-08-10 |
| 00382904416386 | BD GeneOhm™ MRSA ACP Lysis Kit | Geneohm Sciences Canada Inc | 2016-08-10 |
| 00382904416379 | BD GeneOhm™ MRSA ACP Assay (48 tests) | Geneohm Sciences Canada Inc | 2016-08-09 |
| 00382904416393 | BD GeneOhm™ MRSA ACP Assay | Geneohm Sciences Canada Inc | 2016-08-09 |
| 00382904429539 | BD MAX™ MRSA | Geneohm Sciences Canada Inc | 2016-07-27 |
| 00382904419165 | BD MAX™ System | BECTON, DICKINSON AND COMPANY | 2016-05-19 |
| 00875197004441 | cobas® MRSA/SA Controls and Cofactor Kit | Roche Molecular Systems, Inc. | 2016-03-31 |
| 00875197004410 | cobas® MRSA/SA Test | Roche Molecular Systems, Inc. | 2016-03-31 |
| 00875197002973 | LightCycler® MRSA Advanced Test | Roche Molecular Systems, Inc. | 2016-03-31 |
| 00875197002997 | LightCycler® Advanced Lysis | Roche Molecular Systems, Inc. | 2016-03-31 |
| 00875197004427 | cobas® MRSA/SA Test | Roche Molecular Systems, Inc. | 2016-03-31 |