Cleared Traditional

K203741 - Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml (FDA 510(k) Clearance)

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

K203741 · Thermo Fisher Scientific · Microbiology device

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Dec 2021

Decision

363d

Days

Class 2

Risk

K203741 is an FDA 510(k) clearance for the Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefideroco.... Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Thermo Fisher Scientific (Oakwood Village, US). The FDA issued a Cleared decision on December 20, 2021 after a review of 363 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	K203741 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 22, 2020
Decision Date	December 20, 2021
Days to Decision	363 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

261d slower than avg

Panel avg: 102d · This submission: 363d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	JWY Manual Antimicrobial Susceptibility Test Systems
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 866.1640

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.