FDA product code PFR: System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection
PFR is the FDA product code for system, cystic fibrosis transmembrane conductance regulator gene, mutations & variants panel sequencing detection. It is a Class II device, regulated under 21 CFR 866.5900 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under PFR. The average 510(k) review took 328 days (median 328).
Definition
The CFTR gene mutation detection system is used to simultaneously detect and identify a specified panel of mutations and variants in the CFTR gene using sequencing methods. It is intended for carrier screening, as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), and as an initial test to aid in the diagnosis of individuals with suspected CF. It is not intended for stand-alone diagnostic purposes, prenatal diagnostic, or pre-implantation screening.
Classification
| Field | Value |
|---|---|
| Device name | System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing 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 PFR clearance
Top PFR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Illumina, Inc. | 1 | 2013-11-19 |
Most recent PFR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K124006 | Illumina, Inc. | ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY | 2013-11-19 | 328 |
Recalls for PFR devices
openFDA lists no recalls for product code PFR.
Frequently asked questions
What is FDA product code PFR?
PFR is the FDA product code for system, cystic fibrosis transmembrane conductance regulator gene, mutations & variants panel sequencing detection. It is a Class II device, regulated under 21 CFR 866.5900 and reviewed by the Pathology panel.
What device class is PFR?
Class II, regulation 21 CFR 866.5900. Typical premarket route: 510(k).
How long does a 510(k) take for product code PFR?
Across 1 cleared submissions the average was 328 days from receipt to decision (median 328).
Which companies have the most PFR clearances?
Illumina, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PFR
- Run a recall and safety report across every PFR manufacturer
- Watch product code PFR 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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