Cleared Traditional

K190109 - MicroScan Dried Gram Negative MIC/Combo...

K190109 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 85-day FDA review.

K190109 · Beckman Coulter, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2019
Decision
85d
Days
Class 2
Risk

K190109 is an FDA 510(k) clearance for the MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016.... 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 April 18, 2019 after a review of 85 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 K190109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2019
Decision Date April 18, 2019
Days to Decision 85 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
17d faster than avg
Panel avg: 102d · This submission: 85d
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 K190109.
ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)
K191953 · Biomerieux S.A. · Aug 2019
MTS Doxycycline 0.016 - 256 µg/mL
K190914 · Liofilchem S. R. L. · May 2019
ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)
K190154 · Biomerieux S.A. · May 2019
MTS Gentamicin 0.016 - 256 µg/mL
K190252 · Liofilchem S. R. L. · Mar 2019
MTS Ciprofloxacin 0.002 - 32 µg/mL
K183527 · Liofilchem S. R. L. · Mar 2019
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL
K183324 · Thermo Fisher Scientific · Feb 2019