Cleared Traditional

K152774 - The Sensititre 18-24 hour MIC or Breakp...

K152774 is the FDA 510(k) clearance for The Sensititre 18-24 hour MIC or Breakp... by Thermo Fisher Scientific. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K152774 · Thermo Fisher Scientific · Microbiology device
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Dec 2015
Decision
87d
Days
Class 2
Risk

K152774 is an FDA 510(k) clearance for the The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftaz.... 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 21, 2015 after a review of 87 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 K152774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2015
Decision Date December 21, 2015
Days to Decision 87 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
15d faster than avg
Panel avg: 102d · This submission: 87d
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.

Regulatory Peers - JWY Manual Antimicrobial Susceptibility Test Systems

All 360
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K152774.
Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL
K161175 · Liofilchem S. R. L. · Jul 2016
Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml
K153569 · Liofilchem S. R. L. · Jun 2016
Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL
K153687 · Liofilchem S. R. L. · Mar 2016
MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)
K152346 · Beckman Coulter, Inc. · Sep 2015
Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL)
K150556 · Thermo Fisher Scientific · Aug 2015
Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL)
K150236 · Thermo Fisher Scientific · Jul 2015