Cleared Traditional

K221198 - Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL (FDA 510(k) Clearance)

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

K221198 · Thermo Fisher Scientific · Microbiology device

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Mar 2023

Decision

318d

Days

Class 2

Risk

K221198 is an FDA 510(k) clearance for the Sensititre YeastOne Susceptibility System with Fluconazole in the dilution ra.... 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 March 10, 2023 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

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

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Submission Details

510(k) Number	K221198 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 26, 2022
Decision Date	March 10, 2023
Days to Decision	318 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

216d slower than avg

Panel avg: 102d · This submission: 318d

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.