Cleared Traditional

K110106 - VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE

K110106 is an FDA 510(k) clearance for VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULF..., manufactured by bioMerieux, Inc.. The device is a Class 2 Microbiology device with product code LON cleared through the Traditional 510(k) pathway after a 321-day FDA review.

K110106 · bioMerieux, Inc. · Microbiology device
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Nov 2011
Decision
321d
Days
Class 2
Risk

K110106 is an FDA 510(k) clearance for the VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE. Classified as System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (product code LON), Class II - Special Controls.

Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on November 30, 2011 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1645 - 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. Elevated predicate reliance profile. 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, Inc. devices

FDA 510(k) Submission Details - K110106

510(k) Number K110106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2011
Decision Date November 30, 2011
Days to Decision 321 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
219d slower than avg
Panel avg: 102d · This submission: 321d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LON Device Classification - Class 2, Special Controls

Product Code LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1645
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 - LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

All 281
Devices cleared under the same product code (LON) and FDA review panel - the closest regulatory comparables to K110106.
VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE
K111893 · bioMerieux, Inc. · Feb 2012
VITEK 2 STREPTOCOCCUS ERYTHROMYCIN
K111976 · bioMerieux, Inc. · Feb 2012
VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE
K113305 · bioMerieux, Inc. · Feb 2012
VITEK 2 STREPTOCOCCUS PENICILLIN
K112000 · bioMerieux, Inc. · Oct 2011
VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE
K111909 · bioMerieux, Inc. · Oct 2011
VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE
K103752 · bioMerieux, Inc. · Oct 2011