FDA product code NUA: System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
NUA is the FDA product code for system, cystic fibrosis transmembrane conductance regulator, gene mutation detection. It is a Class II device, regulated under 21 CFR 866.5900 and reviewed by the Pathology panel. FDA has cleared 11 510(k) submissions under NUA, from 8 different applicants. The average 510(k) review took 200 days (median 232). 1 De Novo request was granted under it. FDA has posted 2 recalls for NUA devices.
Definition
The cftr gene mutation detection system is a device used to simultaneously detect and identify a panel of mutations and variants in the cftr gene. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (cf), carrier identification, and newborn screening. This device is not intended for stand-alone diagnostic purposes, prenatal diagnostic, pre-implantation or population screening.
Classification
| Field | Value |
|---|---|
| Device name | System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection |
| Device class | Class II |
| Regulation | 21 CFR 866.5900 |
| Review panel | PA — Pathology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NUA clearance
Top NUA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Luminex Molecular Diagnostics, Inc. | 4 | 2016-12-15 |
| Nanosphere, Inc. | 1 | 2009-07-24 |
| Osmetech Molecular Diagnostics | 1 | 2009-07-06 |
| Third Wave Technologies, Inc. | 1 | 2008-03-13 |
| Celera Diagnostics | 1 | 2007-09-07 |
3 more applicants have NUA clearances. See the full list in Caduvo.
Most recent NUA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K163336 | Luminex Molecular Diagnostics, Inc. | xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR | 2016-12-15 | 17 |
| K163347 | Luminex Molecular Diagnostics, Inc. | xTAG Cystic Fibrosis 39 Kit v2 | 2016-12-15 | 17 |
| K083845 | Luminex Molecular Diagnostics, Inc. | XTAG CF60 KIT V2 | 2009-12-11 | 352 |
| K083846 | Luminex Molecular Diagnostics, Inc. | XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267 | 2009-09-01 | 251 |
| K083294 | Nanosphere, Inc. | VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST | 2009-07-24 | 256 |
Recalls for NUA devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-03-31.
Frequently asked questions
What is FDA product code NUA?
NUA is the FDA product code for system, cystic fibrosis transmembrane conductance regulator, gene mutation detection. It is a Class II device, regulated under 21 CFR 866.5900 and reviewed by the Pathology panel.
What device class is NUA?
Class II, regulation 21 CFR 866.5900. Typical premarket route: 510(k).
How long does a 510(k) take for product code NUA?
Across 11 cleared submissions the average was 200 days from receipt to decision (median 232).
Which companies have the most NUA clearances?
Luminex Molecular Diagnostics, Inc. (4); Nanosphere, Inc. (1); Osmetech Molecular Diagnostics (1); Third Wave Technologies, Inc. (1); Celera Diagnostics (1).
Have NUA devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2016-03-31.
Next steps
- Run an FDA pathway report with predicate devices for product code NUA
- Run a recall and safety report across every NUA manufacturer
- Watch product code NUA 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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