DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls
FDA 510(k) K242294 · Diasys Diagnostic Systems GmbH
510(k) numberK242294
Submission
- Device name
- DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls
- Applicant
- Diasys Diagnostic Systems GmbH
Holzheim, DE - Received
- August 2, 2024
- Decision date
- May 9, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PTF – 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 (moderate risk)
- Regulation
- 21 CFR 866.3215
- Specialty
- Microbiology
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
Other 510(k)s with product code PTF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222996 | Access PCTPTF · Traditional | Beckman Coulter, Inc. | 04/26/2023SE |
| K192271 | Access PCT, Access PCT CalibratorsPTF · Traditional | Beckman Coulter, Inc. | 11/26/2019SE |
| K162297 | Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme…PTF · Traditional | Diazyme Laboratories | 04/18/2017SE |
Questions and answers
When was DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls cleared by the FDA?
DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls (K242294) received a 510(k) decision of Substantially Equivalent on May 9, 2025, 280 days after the submission was received.
What is the product code of K242294?
The FDA product code is PTF – Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission, a Class II (moderate risk) device regulated under 21 CFR 866.3215.