FDA product code PFS: System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection
PFS is the FDA product code for system, cystic fibrosis transmembrane conductance regulator gene, variant gene sequence 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 PFS. The average 510(k) review took 77 days (median 77). FDA has posted 2 recalls for PFS devices.
Definition
The CFTR gene variant detection system is used to sequence specified regions of the CFTR gene to detect gene variants. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), those with atypical or non-classic presentation of CF, or when other mutation panels have failed to identify both causative mutations. It is not intended for screening (carrier, newborn, population, or pre-implantation), prenatal diagnostic, or used for stand-alone diagnostic purposes
Classification
| Field | Value |
|---|---|
| Device name | System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence 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 PFS clearance
Top PFS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Illumina, Inc. | 1 | 2013-11-19 |
Most recent PFS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K132750 | Illumina, Inc. | ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY | 2013-11-19 | 77 |
Recalls for PFS devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-11-13.
Frequently asked questions
What is FDA product code PFS?
PFS is the FDA product code for system, cystic fibrosis transmembrane conductance regulator gene, variant gene sequence detection. It is a Class II device, regulated under 21 CFR 866.5900 and reviewed by the Pathology panel.
What device class is PFS?
Class II, regulation 21 CFR 866.5900. Typical premarket route: 510(k).
How long does a 510(k) take for product code PFS?
Across 1 cleared submissions the average was 77 days from receipt to decision (median 77).
Which companies have the most PFS clearances?
Illumina, Inc. (1).
Have PFS devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2014-11-13.
Next steps
- Run an FDA pathway report with predicate devices for product code PFS
- Run a recall and safety report across every PFS manufacturer
- Watch product code PFS 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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