Cleared Traditional

K242294 - DiaSys Procalcitonin FS (FDA 510(k) Clearance)

Also includes:
DiaSys TruCal Procalcitonin Calibrator Set DiaSys TruLab Procalcitonin Bi-Level Controls

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242294 · Diasys Diagnostic Systems GmbH · Microbiology device
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Optimized for regulatory review, auditing and printing
May 2025
Decision
280d
Days
Class 2
Risk

K242294 is an FDA 510(k) clearance for the DiaSys Procalcitonin FS. Classified as Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission (product code PTF), Class II - Special Controls.

Submitted by Diasys Diagnostic Systems GmbH (Holzheim, DE). The FDA issued a Cleared decision on May 9, 2025 after a review of 280 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3215 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diasys Diagnostic Systems GmbH devices

Submission Details

510(k) Number K242294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
178d slower than avg
Panel avg: 102d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 2 - 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
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Consultant

Imagenix, Inc.
Stephen Gorski

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PTF Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

Devices cleared under the same product code (PTF) and FDA review panel - the closest regulatory comparables to K242294.
Access PCT
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