Cleared Traditional

Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL) (K172150) - FDA 510(k) Clearance

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

K172150 · bioMerieux, Inc. · Microbiology device
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Sep 2017
Decision
60d
Days
Class 2
Risk

K172150 is an FDA 510(k) clearance for the Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL). Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on September 15, 2017 after a review of 60 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 bioMerieux, Inc. devices

Submission Details

510(k) Number K172150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2017
Decision Date September 15, 2017
Days to Decision 60 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
42d faster than avg
Panel avg: 102d · This submission: 60d
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 K172150.
Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL
K180339 · Liofilchem S. R. L. · Apr 2018
Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL
K180330 · Liofilchem S. R. L. · Mar 2018
Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL
K173817 · Liofilchem S. R. L. · Feb 2018
Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)
K170670 · bioMerieux, Inc. · May 2017
MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL)
K152346 · Beckman Coulter, Inc. · Sep 2015
ETEST CEFTAROLINE
K121002 · bioMerieux, Inc. · Oct 2012