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510(k) K242294

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls by Diasys Diagnostic Systems GmbH — Product Code PTF

K242294 is an FDA 510(k) premarket notification submitted by Diasys Diagnostic Systems GmbH for the device "DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls". The FDA issued a decision of Substantially Equivalent on May 9, 2025. The device falls under product code 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 device regulated under 21 CFR 866.3215.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2025
Date Received
August 2, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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 Number
866.3215
Review Panel
MI
Submission Type

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 clearances for product code PTF

  • K222996 — Access PCT (April 26, 2023)
  • K192271 — Access PCT, Access PCT Calibrators (November 26, 2019)
  • K162297 — Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, D (April 18, 2017)

FDA data resources