Cleared Special

K152346 - MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)

K152346 is an FDA 510(k) clearance for MicroScan Dried Gram Positive MIC/Combo..., manufactured by Beckman Coulter, Inc.. The device is a Class 2 Microbiology device with product code JWY cleared through the Special 510(k) pathway after a 27-day FDA review.

K152346 · Beckman Coulter, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
27d
Days
Class 2
Risk

K152346 is an FDA 510(k) clearance for the MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL). Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (West Sacramento, US). The FDA issued a Cleared decision on September 16, 2015 after a review of 27 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K152346

510(k) Number K152346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2015
Decision Date September 16, 2015
Days to Decision 27 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 102d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 426
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K152346.
Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL
K153687 · Liofilchem S. R. L. · Mar 2016
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL
K152774 · Thermo Fisher Scientific · Dec 2015
Etest Ceftaroline (0.002 - 32ug/ml)
K151873 · Biomerieux S.A. · Oct 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
Sensititre Susceptibility plates
K143288 · Thermo Fisher Scientific · Apr 2015
K152346 · MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)
Download PDF FDA Summary Beckman Coulter, Inc.