FDA product code · Microbiology
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
24 FDA decisions since 2004. 510(k) reviews decided 2021–2025 took a median of 26 days (half between 24 and 27). 12 recalls name this code, 0 of them Class I. The most-cited predicate is K071026, named by 5 later devices.
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.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NQX at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · NQX
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NQX
75in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQX
15in 2025
MAUDE reports naming product code NQX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 3 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 70 | 1 | 1 |
| 2011 | 2 | — | 6 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 4 | 75 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 2 | — | 0 | 8 |
| 2025 | 0 | — | 1 | 15 |
| 2026 | 0 | — | 0 | — |
Planning a device in NQX? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportRelated product codes
Other codes under 21 CFR 866.1640.