FDA product code PFF: High Throughput Dna Sequence Analyzer
PFF is the FDA product code for high throughput dna sequence analyzer. It is a Class II device, regulated under 21 CFR 862.2265 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under PFF. The average 510(k) review took 142 days (median 142). 1 De Novo request was granted under it. FDA has posted 11 recalls for PFF devices, 6 initiated in the last five years.
Definition
A high throughput sequencing technology performing targeted DNA sequencing of amplicons from a defined genetic region or a subset of genes in human genomic DNA from a clinical sample.
Classification
| Field | Value |
|---|---|
| Device name | High Throughput Dna Sequence Analyzer |
| Device class | Class II |
| Regulation | 21 CFR 862.2265 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for PFF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 142 |
Compare with all 510(k) review times · Search every PFF clearance
Top PFF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Life Technologies Corporation | 1 | 2017-06-22 |
Most recent PFF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K170299 | Life Technologies Corporation | Ion PGM Dx System | 2017-06-22 | 142 |
Recalls for PFF devices
11 product recalls in 6 recall events; 6 initiated in the last five years and 1 still open. Most recent: 2024-02-07.
| Year | Recalls |
|---|---|
| 2019 | 4 |
| 2022 | 3 |
| 2023 | 2 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code PFF?
PFF is the FDA product code for high throughput dna sequence analyzer. It is a Class II device, regulated under 21 CFR 862.2265 and reviewed by the Clinical Toxicology panel.
What device class is PFF?
Class II, regulation 21 CFR 862.2265. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code PFF?
Across 1 cleared submissions the average was 142 days from receipt to decision (median 142).
Which companies have the most PFF clearances?
Life Technologies Corporation (1).
Have PFF devices been recalled?
Yes: 11 product recalls across 6 recall events; the most recent began 2024-02-07.
Next steps
- Run an FDA pathway report with predicate devices for product code PFF
- Run a recall and safety report across every PFF manufacturer
- Watch product code PFF 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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