Cleared Traditional

ETEST Plazomicin (PLZ) (0.016-256 µg/mL) (K200512) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200512 · Biom?rieux SA · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
66d
Days
Class 2
Risk

K200512 is an FDA 510(k) clearance for the ETEST Plazomicin (PLZ) (0.016-256 µg/mL). Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Biom?rieux SA (Marcy-L'Etoile, FR). The FDA issued a Cleared decision on May 7, 2020 after a review of 66 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 Biom?rieux SA devices

Submission Details

510(k) Number K200512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2020
Decision Date May 07, 2020
Days to Decision 66 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
36d faster than avg
Panel avg: 102d · This submission: 66d
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 124
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K200512.
MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL
K211672 · Liofilchem S. R. L. · Oct 2021
Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL)
K202612 · Thermo Fisher Scientific · Jul 2021
MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)
K202423 · Beckman Coulter, Inc. · May 2021
MTS Lefamulin 0.016- 256 µg/mL
K200308 · Liofilchem S. R. 1. · Apr 2020
MTS Omadacycline 0.002 - 32 ug/mL
K200180 · Liofilchem S. R. L. · Mar 2020
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml
K193538 · Thermo Fisher Scientific · Mar 2020