Cleared Traditional

K183033 - Sensititre 18-24 hour MIC or Breakpoint...

K183033 is the FDA 510(k) clearance for Sensititre 18-24 hour MIC or Breakpoint... by Thermo Fisher Scientific. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K183033 · Thermo Fisher Scientific · Microbiology device
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Jan 2019
Decision
64d
Days
Class 2
Risk

K183033 is an FDA 510(k) clearance for the Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycli.... 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 January 4, 2019 after a review of 64 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.

View all Thermo Fisher Scientific devices

Submission Details

510(k) Number K183033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2018
Decision Date January 04, 2019
Days to Decision 64 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
38d faster than avg
Panel avg: 102d · This submission: 64d
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 K183033.
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL
K183324 · Thermo Fisher Scientific · Feb 2019
ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)
K183031 · Biomerieux S.A. · Jan 2019
MTS Tetracycline 0.016 - 256 ug/mL
K183140 · Liofilchem S. R. L. · Jan 2019
MTS Levofloxacin 0.002 - 32 µg/mL
K183115 · Liofilchem S. R. L. · Dec 2018
MTS Omadacycline 0.002-32 µg/mL
K182922 · Liofilchem S. R. L. · Dec 2018
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL
K182797 · Thermo Fisher Scientific · Nov 2018