FDA Product Code NQX: System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
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.
Leading manufacturers include Cepheid, Infectio Diagnostic (I.D.I.), Inc. and Bd Diagnostics (Geneohm Sciences Canada, Inc).
24
Total
24
Cleared
111d
Avg days
2004
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg
23d
recently vs 115d historically
FDA 510(k) Cleared System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen Devices (Product Code NQX)
24 devices
Cleared
Dec 18, 2024
Xpert MRSA/SA SSTI
Cepheid
Microbiology
23d
Cleared
Oct 25, 2024
Xpert® SA Nasal Complete
Cepheid
Microbiology
28d
Cleared
Sep 25, 2019
ARIES MRSA Assay
Luminex Corporation
Microbiology
86d
Cleared
Apr 25, 2019
Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
Cepheid
Microbiology
30d
Cleared
Nov 23, 2016
Xpert MRSA NxG
Cepheid
Microbiology
84d
Cleared
Dec 17, 2014
cobas MRSA/SA Test
Roche Molecular Systems, Inc.
Microbiology
85d
Cleared
Dec 20, 2013
BD MAX MRSA XT, BD MAX INSTRUMENT
Geneohm Sciences Canada, Inc.
Microbiology
25d
Cleared
Nov 26, 2013
BD MAX STAPHSR ASSAY, INSTRUMENT
Geneohm Sciences Canada, Inc. (Bd Diagnostics)
Microbiology
78d
Cleared
Oct 17, 2013
MRSA/SA ELITE MGB, ELITE MGB SOFTWARE
Elitechgroup Epoch Biosciences
Microbiology
71d
Cleared
Jun 20, 2013
XPERT MRSA/SA BLOOD CULTURE ASSAY
Cepheid
Microbiology
80d
Cleared
Jul 05, 2012
BD MAX MRSA ASSAY, BD MAX INSTRUMENT
Bd Diagnostics (Geneohm Sciences Canada, Inc)
Microbiology
170d
Cleared
Jun 01, 2012
MRSA/SA ELITE MGB
Elitech
Microbiology
242d
Cleared
Dec 16, 2011
VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)
Nanosphere, Inc.
Microbiology
115d
Cleared
May 20, 2011
NUCLISENS EASYQ MRSA
bioMerieux, Inc.
Microbiology
240d
Cleared
Jul 28, 2010
XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10
Cepheid
Microbiology
22d
Cleared
Jul 06, 2010
LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727
Roche Molecular Systems, Inc.
Microbiology
419d
Cleared
Jun 01, 2010
XPERT MRSA/SA NASAL ASSAY
Cepheid
Microbiology
70d
Cleared
Dec 15, 2009
BD GENEOHM MRSA ACP ASSAY
Bd Diagnostics (Geneohm Sciences, Inc.)
Microbiology
50d
Cleared
Sep 29, 2008
XPERT MRSA/SA BLOOD CULTURE ASSAY
Cepheid
Microbiology
61d
Cleared
Sep 24, 2008
XPERT MRSA/SA SSTI ASSAY
Cepheid
Microbiology
183d
Cleared
Dec 20, 2007
BD GENEOHM STAPHSR ASSAY
Bd Diagnostics (Geneohm Sciences Canada, Inc)
Microbiology
253d
Cleared
Apr 17, 2007
XPERT MRSA
Cepheid
Microbiology
60d
Cleared
Oct 22, 2004
IDI-MRSA ASSAY
Infectio Diagnostic (I.D.I.), Inc.
Microbiology
52d
Cleared
Mar 18, 2004
IDI-MRSA
Infectio Diagnostic (I.D.I.), Inc.
Microbiology
143d
About Product Code NQX - Regulatory Context
510(k) Submission Activity
24 total 510(k) submissions under product code NQX since 2004, with 24 receiving FDA clearance (average review time: 111 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - NQX Product Code
Recent submissions under NQX have taken an average of 23 days to reach a decision - down from 115 days historically, suggesting improved FDA processing for this classification.
NQX devices are reviewed by the Microbiology panel. Browse all Microbiology devices →