Cleared Traditional

K142338 - Sensititre HP MIC Susceptibility Plate ...

K142338 is the FDA 510(k) clearance for Sensititre HP MIC Susceptibility Plate ... by Thermo Fisher Scientific. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K142338 · Thermo Fisher Scientific · Microbiology device
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Mar 2015
Decision
193d
Days
Class 2
Risk

K142338 is an FDA 510(k) clearance for the Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml). 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 March 2, 2015 after a review of 193 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

Submission Details

510(k) Number K142338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2014
Decision Date March 02, 2015
Days to Decision 193 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
91d slower than avg
Panel avg: 102d · This submission: 193d
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 K142338.
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K150236 · Thermo Fisher Scientific · Jul 2015
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The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml)
K143526 · Thermo Fisher Scientific · Mar 2015
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K142151 · Thermo Fisher Scientific · Dec 2014
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K141651 · Thermo Fisher Scientific · Oct 2014