Cleared Traditional

ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML (K102668) - FDA 510(k) Clearance

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

K102668 · BIOMERIEUX · Microbiology device
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Nov 2010
Decision
62d
Days
Class 2
Risk

K102668 is an FDA 510(k) clearance for the ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by BIOMERIEUX (Craponne, FR). The FDA issued a Cleared decision on November 17, 2010 after a review of 62 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 devices

Submission Details

510(k) Number K102668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2010
Decision Date November 17, 2010
Days to Decision 62 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 102d · This submission: 62d
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 K102668.
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K061687 · Dade Behring, Inc. · Jul 2006
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS
K061536 · Dade Behring, Inc. · Jul 2006
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K051202 · Dade Behring, Inc. · Jun 2005