PTF — Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission Class II
FDA product code PTF covers "Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission", a Class II medical device regulated under 21 CFR 866.3215. Submissions are reviewed by the Microbiology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PTF
- Device Class
- Class II
- Regulation Number
- 866.3215
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242294 | diasys diagnostic systems | DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruL | May 9, 2025 |
| K222996 | beckman coulter | Access PCT | April 26, 2023 |
| K192271 | beckman coulter | Access PCT, Access PCT Calibrators | November 26, 2019 |
| K162297 | diazyme laboratories | Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, D | April 18, 2017 |