Cleared Traditional

K102535 - ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML

K102535 is an FDA 510(k) clearance for ETEST TELAVANCIN IN 0.002-32 UG/ML AND ..., manufactured by Biomerieux S.A.. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K102535 · Biomerieux S.A. · Microbiology device
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May 2011
Decision
255d
Days
Class 2
Risk

K102535 is an FDA 510(k) clearance for the ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Biomerieux S.A. (Craponne, FR). The FDA issued a Cleared decision on May 16, 2011 after a review of 255 days - an extended review 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: 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 Biomerieux S.A. devices

FDA 510(k) Submission Details - K102535

510(k) Number K102535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2010
Decision Date May 16, 2011
Days to Decision 255 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
153d slower than avg
Panel avg: 102d · This submission: 255d
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 411
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K102535.
VIZION
K112276 · Trek Diagnostic Systems · Nov 2011
SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES
K111615 · Trek Diagnostic Systems · Nov 2011
SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE...
K111429 · Trek Diagnostic Systems, Ltd. · Aug 2011
ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML
K102668 · BIOMERIEUX · Nov 2010
ETEST MOXIFLOXACIN 0.002-32 UG/ML
K093604 · Ab Biomerieux · Aug 2010
SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES
K093741 · Trek Diagnostic Systems, Ltd. · Feb 2010