Cleared Traditional

K170670 - Etest Ceftolozane/ Tazobactam (0.016-25...

K170670 is an FDA 510(k) clearance for Etest Ceftolozane/ Tazobactam (0.016-25..., manufactured by bioMerieux, Inc.. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K170670 · bioMerieux, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
86d
Days
Class 2
Risk

K170670 is an FDA 510(k) clearance for the Etest Ceftolozane/ Tazobactam (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 May 31, 2017 after a review of 86 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

FDA 510(k) Submission Details - K170670

510(k) Number K170670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2017
Decision Date May 31, 2017
Days to Decision 86 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
16d faster than avg
Panel avg: 102d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWY Device Classification - Class 2, Special Controls

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 391
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K170670.
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 – 8 ug/mL
K171870 · Thermo Fisher Scientific · Aug 2017
Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL
K171906 · Liofilchem S. R. L. · Aug 2017
Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL
K170772 · Liofilchem S. R. L. · Jun 2017
Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL
K170892 · Liofilchem S. R. L. · May 2017
Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL
K163517 · Liofilchem S. R. L. · Mar 2017
Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL
K163298 · Liofilchem S. R. L. · Feb 2017