Cleared Traditional

K143288 - Sensititre Susceptibility plates

K143288 is an FDA 510(k) clearance for Sensititre Susceptibility plates, 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 135-day FDA review.

K143288 · Thermo Fisher Scientific · Microbiology device
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Apr 2015
Decision
135d
Days
Class 2
Risk

K143288 is an FDA 510(k) clearance for the Sensititre Susceptibility plates. 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 1, 2015 after a review of 135 days - within the typical 510(k) review window.

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 - K143288

510(k) Number K143288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2014
Decision Date April 01, 2015
Days to Decision 135 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
33d slower than avg
Panel avg: 102d · This submission: 135d
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 K143288.
MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)
K152346 · Beckman Coulter, Inc. · Sep 2015
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K150236 · Thermo Fisher Scientific · Jul 2015
The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml)
K143526 · Thermo Fisher Scientific · Mar 2015
Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml)
K142338 · Thermo Fisher Scientific · Mar 2015
Sensititre Susceptibility Plates
K143381 · Thermo Fisher Scientific · Feb 2015