Cleared Traditional

K142338 - Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml)

K142338 is an FDA 510(k) clearance for Sensititre HP MIC Susceptibility Plate ..., 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 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

FDA 510(k) Submission Details - K142338

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.

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 404
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K142338.
Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL)
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The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml)
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SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K142151 · Thermo Fisher Scientific · Dec 2014
SENSITITRE SUSCEPTIBILITY PLATES
K141651 · Thermo Fisher Scientific · Oct 2014