Cleared Traditional

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

K242294 · Diasys Diagnostic Systems GmbH · Microbiology
May 2025
Decision
280d
Days
Class 2
Risk

About This 510(k) Submission

K242294 is an FDA 510(k) clearance for the DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls, a Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission (Class II — Special Controls, product code PTF), submitted by Diasys Diagnostic Systems GmbH (Holzheim, DE). The FDA issued a Cleared decision on May 9, 2025, 280 days after receiving the submission on August 2, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3215.

Submission Details

510(k) Number K242294 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 2024
Decision Date May 09, 2025
Days to Decision 280 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

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 — Special Controls
CFR Regulation 21 CFR 866.3215
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