Cleared Traditional

K183527 - MTS Ciprofloxacin 0.002 - 32 µg/mL

K183527 is the FDA 510(k) clearance for MTS Ciprofloxacin 0.002 - 32 µg/mL by Liofilchem S. R. L.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K183527 · Liofilchem S. R. L. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
90d
Days
Class 2
Risk

K183527 is an FDA 510(k) clearance for the MTS Ciprofloxacin 0.002 - 32 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 March 19, 2019 after a review of 90 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 K183527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2018
Decision Date March 19, 2019
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 102d · This submission: 90d
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 Consultant

Laboratory Specialists, Inc.
Anne R. Windau

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K183527.
ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)
K190154 · Biomerieux S.A. · May 2019
MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL)
K190109 · Beckman Coulter, Inc. · Apr 2019
MTS Gentamicin 0.016 - 256 µg/mL
K190252 · 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
ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)
K183031 · Biomerieux S.A. · Jan 2019
MTS Tetracycline 0.016 - 256 ug/mL
K183140 · Liofilchem S. R. L. · Jan 2019