Cleared Traditional

K192355 - MicroScan Dried Gram Negative MIC/Combo...

K192355 is the FDA 510(k) clearance for MicroScan Dried Gram Negative MIC/Combo... by Beckman Coulter, Inc.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K192355 · Beckman Coulter, Inc. · Microbiology device
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Nov 2019
Decision
77d
Days
Class 2
Risk

K192355 is an FDA 510(k) clearance for the MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32.... 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 November 14, 2019 after a review of 77 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 Beckman Coulter, Inc. devices

Submission Details

510(k) Number K192355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2019
Decision Date November 14, 2019
Days to Decision 77 days
Submission Type Traditional
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
25d faster than avg
Panel avg: 102d · This submission: 77d
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 K192355.
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ETEST Delafloxacin (DFX) (0.002-32 µg/mL)
K192738 · Biomerieux S.A. · Nov 2019
Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml
K192729 · Thermo Fisher Scientific · Nov 2019
MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL
K192345 · Liofilchem S. R. L. · Oct 2019
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL
K192250 · Thermo Fisher Scientific · Oct 2019