Cleared Traditional

K243738 - The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL (FDA 510(k) Clearance)

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

K243738 · Thermo Fisher Scientific · Microbiology device

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Feb 2025

Decision

85d

Days

Class 2

Risk

K243738 is an FDA 510(k) clearance for the The Sensititre YeastOne Susceptibility System with Micafungin in the dilution.... Classified as Susceptibility Test Plate, Antifungal (product code NGZ), Class II - Special Controls.

Submitted by Thermo Fisher Scientific (Oakwood Village, US). The FDA issued a Cleared decision on February 27, 2025 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number	K243738 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 04, 2024
Decision Date	February 27, 2025
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

17d faster than avg

Panel avg: 102d · This submission: 85d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	NGZ Susceptibility Test Plate, Antifungal
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 866.1640
Definition	The Device Is An In Vitro Diagnostic Device Intended For Use In Determining Quantitative Susceptibility Of Candida Species To Various Antifungal Agents Diluted In Varying Concentration In A Microtiter Plate Format.

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.