Cleared Traditional

Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL (K163298) - FDA 510(k) Clearance

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

K163298 · Liofilchem S. R. L. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
92d
Days
Class 2
Risk

K163298 is an FDA 510(k) clearance for the Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Liofilchem S. R. L. (Roseto Degli Abruzzi, IT). The FDA issued a Cleared decision on February 22, 2017 after a review of 92 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Liofilchem S. R. L. devices

Submission Details

510(k) Number K163298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2016
Decision Date February 22, 2017
Days to Decision 92 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 102d · This submission: 92d
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 125
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K163298.
Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL
K173817 · Liofilchem S. R. L. · Feb 2018
Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)
K172150 · bioMerieux, Inc. · Sep 2017
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
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS
K061687 · Dade Behring, Inc. · Jul 2006