NQX · System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Microbiology · 21 CFR 866.1640 · Class 2
Overview
| Product Code | NQX |
|---|---|
| Device Name | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen |
| Regulation | 21 CFR 866.1640 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 24)
Showing 20 most recent of 24 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243625 | Xpert MRSA/SA SSTI | Cepheid® | Dec 18, 2024 | SESE |
| K243070 | Xpert® SA Nasal Complete | Cepheid® | Oct 25, 2024 | SESE |
| K191742 | ARIES MRSA Assay | Luminex Corporation | Sep 25, 2019 | SESE |
| K190771 | Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System | Cepheid | Apr 25, 2019 | SESE |
| K162444 | Xpert MRSA NxG | Cepheid | Nov 23, 2016 | SESE |
| K142721 | cobas MRSA/SA Test | Roche Molecular Systems, Inc. | Dec 17, 2014 | SESE |
| K133605 | BD MAX MRSA XT, BD MAX INSTRUMENT | Geneohm Sciences Canada, Inc. | Dec 20, 2013 | SESE |
| K132822 | BD MAX STAPHSR ASSAY, INSTRUMENT | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | Nov 26, 2013 | SESE |
| K132468 | MRSA/SA ELITE MGB, ELITE MGB SOFTWARE | Elitechgroup Epoch Biosciences | Oct 17, 2013 | SESE |
| K130894 | XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE | Cepheid | Jun 20, 2013 | SESE |
| K120138 | BD MAX MRSA ASSAY, BD MAX INSTRUMENT | Bd Diagnostics (Geneohm Sciences Canada, Inc) | Jul 5, 2012 | SESE |
| K112937 | MRSA/SA ELITE MGB | Elitech | Jun 1, 2012 | SESE |
| K112424 | VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S) | Nanosphere, Inc. | Dec 16, 2011 | SESE |
| K102740 | NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EASYQ INCUBATOR (110 VOLT); NUCLISENS DIRECTOR V.2.6 | bioMerieux, Inc. | May 20, 2011 | SESE |
| K101879 | XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10 | Cepheid | Jul 28, 2010 | SESE |
| K091409 | LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727 | Roche Molecular Systems, Inc. | Jul 6, 2010 | SESE |
| K100822 | XPERT MRSA/SA NASAL ASSAY | Cepheid | Jun 1, 2010 | SESE |
| K093346 | BD GENEOHM MRSA ACP ASSAY | Bd Diagnostics (Geneohm Sciences, Inc.) | Dec 15, 2009 | SESE |
| K082140 | XPERT MRSA/SA BLOOD CULTURE ASSAY | Cepheid | Sep 29, 2008 | SESE |
| K080837 | XPERT MRSA/SA SSTI ASSAY | Cepheid | Sep 24, 2008 | SESE |
Top Applicants
- Cepheid — 8 clearances
- Roche Molecular Systems, Inc. — 2 clearances
- Infectio Diagnostic (I.D.I.), Inc. — 2 clearances
- Cepheid® — 2 clearances
- Bd Diagnostics (Geneohm Sciences Canada, Inc) — 2 clearances
