Cleared Traditional

Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2) (K242453) - FDA 510(k) Clearance

Also marketed or referenced as:
Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)

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

K242453 · Terragene S.A. · General Hospital
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Dec 2024
Decision
115d
Days
Class 2
Risk

K242453 is an FDA 510(k) clearance for the Terragene® Bionova® Photon Process Challenge Device with unique-point integra.... Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Terragene S.A. (Alvear, AR). The FDA issued a Cleared decision on December 12, 2024 after a review of 115 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Terragene S.A. devices

Submission Details

510(k) Number K242453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2024
Decision Date December 12, 2024
Days to Decision 115 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 129d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRC Indicator, Biological Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
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 General Hospital devices follow this clearance model.

Regulatory Peers - FRC Indicator, Biological Sterilization Process

All 88
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Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
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