FDA product code PTF: Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
PTF is the FDA product code for assay to measure pct to aid in the risk assessment of critically ill patients on their first day of icu admission. It is a Class II device, regulated under 21 CFR 866.3215 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under PTF, 2 in the last five years, from 3 different applicants. The average 510(k) review took 208 days (median 228); 280 days on average over the last three years. FDA has posted 1 recall for PTF devices, 1 initiated in the last five years.
Definition
Assay to measure procalcitonin to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock
Classification
| Field | Value |
|---|---|
| Device name | Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission |
| Device class | Class II |
| Regulation | 21 CFR 866.3215 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for PTF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 245 |
| 2019 | 1 | 96 |
| 2023 | 1 | 210 |
| 2025 | 1 | 280 |
Compare with all 510(k) review times · Search every PTF clearance
Top PTF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Coulter, Inc. | 2 | 2023-04-26 |
| Diasys Diagnostic Systems GmbH | 1 | 2025-05-09 |
| Diazyme Laboratories | 1 | 2017-04-18 |
Most recent PTF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242294 | Diasys Diagnostic Systems GmbH | DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls | 2025-05-09 | 280 |
| K222996 | Beckman Coulter, Inc. | Access PCT | 2023-04-26 | 210 |
| K192271 | Beckman Coulter, Inc. | Access PCT, Access PCT Calibrators | 2019-11-26 | 96 |
| K162297 | Diazyme Laboratories | Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set | 2017-04-18 | 245 |
Recalls for PTF devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-01-02.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code PTF?
PTF is the FDA product code for assay to measure pct to aid in the risk assessment of critically ill patients on their first day of icu admission. It is a Class II device, regulated under 21 CFR 866.3215 and reviewed by the Microbiology panel.
What device class is PTF?
Class II, regulation 21 CFR 866.3215. Typical premarket route: 510(k).
How long does a 510(k) take for product code PTF?
Across 4 cleared submissions the average was 208 days from receipt to decision (median 228).
Which companies have the most PTF clearances?
Beckman Coulter, Inc. (2); Diasys Diagnostic Systems GmbH (1); Diazyme Laboratories (1).
Have PTF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-01-02.
Next steps
- Run an FDA pathway report with predicate devices for product code PTF
- Run a recall and safety report across every PTF manufacturer
- Watch product code PTF 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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