Cleared Traditional

K112228 - VITEK 2 STREPTOCOCCUS LEVOFLOXACIN

K112228 is the FDA 510(k) clearance for VITEK 2 STREPTOCOCCUS LEVOFLOXACIN by bioMerieux, Inc.. It is a Class 2 Microbiology device (product code LON) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K112228 · bioMerieux, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
61d
Days
Class 2
Risk

K112228 is an FDA 510(k) clearance for the VITEK 2 STREPTOCOCCUS LEVOFLOXACIN. 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 October 3, 2011 after a review of 61 days - a notably fast clearance cycle.

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: 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

Submission Details

510(k) Number K112228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2011
Decision Date October 03, 2011
Days to Decision 61 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
41d faster than avg
Panel avg: 102d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 279
Devices cleared under the same product code (LON) and FDA review panel - the closest regulatory comparables to K112228.
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
VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN
K112129 · bioMerieux, Inc. · Sep 2011
VITEK 2 STRPTOCOCCUS AMPICILLIN
K112075 · bioMerieux, Inc. · Sep 2011
VITEK 2 AST-ST LINEZOLID
K111599 · bioMerieux, Inc. · Aug 2011