Cleared Traditional

K203741 - Sensititre 18-24 hour MIC or Breakpoint...

K203741 is an FDA 510(k) clearance for Sensititre 18-24 hour MIC or Breakpoint..., manufactured by Thermo Fisher Scientific. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 363-day FDA review.

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.

View all Thermo Fisher Scientific devices

FDA 510(k) Submission Details - K203741

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.

JWY Device Classification - Class 2, Special Controls

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.

Regulatory Peers - JWY Manual Antimicrobial Susceptibility Test Systems

All 391
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K203741.
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae)
K230935 · Thermo Fisher Scientific · Jun 2023
ComASP Cefiderocol 0.008-128
K230479 · Liofilchem S. R. L. · May 2023
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae)
K223844 · Thermo Fisher Scientific · Mar 2023
ETEST Fosfomycin (FO) (0.032-512 µg/mL)
K210757 · Biomerieux S.A. · Nov 2021
MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL
K211672 · Liofilchem S. R. L. · Oct 2021
Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL)
K202612 · Thermo Fisher Scientific · Jul 2021