PTF — Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission Class II
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 |