Cleared Traditional

K112000 - VITEK 2 STREPTOCOCCUS PENICILLIN

K112000 is the FDA 510(k) clearance for VITEK 2 STREPTOCOCCUS PENICILLIN by bioMerieux, Inc.. It is a Class 2 Microbiology device (product code LON) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K112000 · bioMerieux, Inc. · Microbiology device
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Oct 2011
Decision
105d
Days
Class 2
Risk

K112000 is an FDA 510(k) clearance for the VITEK 2 STREPTOCOCCUS PENICILLIN. 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 26, 2011 after a review of 105 days - within the typical 510(k) review window.

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. 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, Inc. devices

Submission Details

510(k) Number K112000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2011
Decision Date October 26, 2011
Days to Decision 105 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
3d slower than avg
Panel avg: 102d · This submission: 105d
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 K112000.
VITEK 2 STREPTOCOCCUS ERYTHROMYCIN
K111976 · bioMerieux, Inc. · Feb 2012
VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE
K113305 · bioMerieux, Inc. · Feb 2012
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE
K110106 · bioMerieux, Inc. · Nov 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 2 STREPTOCOCCUS LEVOFLOXACIN
K112228 · bioMerieux, Inc. · Oct 2011