FDA product code NQX: System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
NQX is the FDA product code for system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel. FDA has cleared 24 510(k) submissions under NQX, 2 in the last five years, from 13 different applicants. The average 510(k) review took 111 days (median 79); 26 days on average over the last three years. FDA has posted 20 recalls for NQX devices, 1 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen |
| Device class | Class II |
| Regulation | 21 CFR 866.1640 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for NQX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 2 | 58 |
| 2024 | 2 | 26 |
Compare with all 510(k) review times · Search every NQX clearance
Top NQX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cepheid | 8 | 2019-04-25 |
| Cepheid® | 2 | 2024-12-18 |
| Roche Molecular Systems, Inc. | 2 | 2014-12-17 |
| Bd Diagnostics (Geneohm Sciences Canada, Inc) | 2 | 2012-07-05 |
| Infectio Diagnostic (I.D.I.), Inc. | 2 | 2004-10-22 |
8 more applicants have NQX clearances. See the full list in Caduvo.
Most recent NQX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243625 | Cepheid® | Xpert MRSA/SA SSTI | 2024-12-18 | 23 |
| K243070 | Cepheid® | Xpert® SA Nasal Complete | 2024-10-25 | 28 |
| K191742 | Luminex Corporation | ARIES MRSA Assay | 2019-09-25 | 86 |
| K190771 | Cepheid | Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System | 2019-04-25 | 30 |
| K162444 | Cepheid | Xpert MRSA NxG | 2016-11-23 | 84 |
Recalls for NQX devices
20 product recalls in 12 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-08-06.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 4 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code NQX?
NQX is the FDA product code for system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel.
What device class is NQX?
Class II, regulation 21 CFR 866.1640. Typical premarket route: 510(k).
How long does a 510(k) take for product code NQX?
Across 24 cleared submissions the average was 111 days from receipt to decision (median 79).
Which companies have the most NQX clearances?
Cepheid (8); Cepheid® (2); Roche Molecular Systems, Inc. (2); Bd Diagnostics (Geneohm Sciences Canada, Inc) (2); Infectio Diagnostic (I.D.I.), Inc. (2).
Have NQX devices been recalled?
Yes: 20 product recalls across 12 recall events; the most recent began 2025-08-06.
Next steps
- Run an FDA pathway report with predicate devices for product code NQX
- Run a recall and safety report across every NQX manufacturer
- Watch product code NQX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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