Cleared Traditional

K242658 - The Sensititre 18-24 hour MIC or Breakp...

K242658 is an FDA 510(k) clearance for The Sensititre 18-24 hour MIC or Breakp..., 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 223-day FDA review.

K242658 · Thermo Fisher Scientific · Microbiology device
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Apr 2025
Decision
223d
Days
Class 2
Risk

K242658 is an FDA 510(k) clearance for the The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifl.... 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 April 15, 2025 after a review of 223 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 - K242658

510(k) Number K242658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2024
Decision Date April 15, 2025
Days to Decision 223 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 102d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

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 K242658.
ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)
K250856 · Biom?rieux · Jun 2025
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL
K242659 · Thermo Fisher Scientific · May 2025
ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)
K250274 · Biomerieux S.A. · Apr 2025
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL
K242905 · Thermo Fisher Scientific · Feb 2025
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL
K243201 · Thermo Fisher Scientific · Feb 2025
MTS Ceftobiprole 0.002-32 µg/mL
K243202 · Liofilchem S. R. L. · Jan 2025