NQX — System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen Class II
Classification Details
- Product Code
- NQX
- Device Class
- Class II
- Regulation Number
- 866.1640
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243625 | cepheid® | Xpert MRSA/SA SSTI | December 18, 2024 |
| K243070 | cepheid® | Xpert® SA Nasal Complete | October 25, 2024 |
| K191742 | luminex corporation | ARIES MRSA Assay | September 25, 2019 |
| K190771 | cepheid | Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, | April 25, 2019 |
| K162444 | cepheid | Xpert MRSA NxG | November 23, 2016 |
| K142721 | roche molecular systems | cobas MRSA/SA Test | December 17, 2014 |
| K133605 | geneohm sciences canada | BD MAX MRSA XT, BD MAX INSTRUMENT | December 20, 2013 |
| K132822 | geneohm sciences canada, inc. (bd diagnostics) | BD MAX STAPHSR ASSAY, INSTRUMENT | November 26, 2013 |
| K132468 | elitechgroup epoch biosciences | MRSA/SA ELITE MGB, ELITE MGB SOFTWARE | October 17, 2013 |
| K130894 | cepheid | XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX- | June 20, 2013 |
| K120138 | bd diagnostics (geneohm sciences canada, inc) | BD MAX MRSA ASSAY, BD MAX INSTRUMENT | July 5, 2012 |
| K112937 | elitech | MRSA/SA ELITE MGB | June 1, 2012 |
| K112424 | nanosphere | VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S) | December 16, 2011 |
| K102740 | biomerieux | NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EASYQ INCUBATOR (110 V | May 20, 2011 |
| K101879 | cepheid | XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10 | July 28, 2010 |
| K091409 | roche molecular systems | LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODE | July 6, 2010 |
| K100822 | cepheid | XPERT MRSA/SA NASAL ASSAY | June 1, 2010 |
| K093346 | bd diagnostics (geneohm sciences, inc.) | BD GENEOHM MRSA ACP ASSAY | December 15, 2009 |
| K082140 | cepheid | XPERT MRSA/SA BLOOD CULTURE ASSAY | September 29, 2008 |
| K080837 | cepheid | XPERT MRSA/SA SSTI ASSAY | September 24, 2008 |