Cleared Traditional

K113190 - TRU LEGIONELLA

K113190 is an FDA 510(k) clearance for TRU LEGIONELLA, manufactured by Meridian Bioscience, Inc.. The device is a Class 2 Microbiology device with product code MJH cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K113190 · Meridian Bioscience, Inc. · Microbiology device
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Feb 2012
Decision
116d
Days
Class 2
Risk

K113190 is an FDA 510(k) clearance for the TRU LEGIONELLA. Classified as Legionella, Spp., Elisa (product code MJH), Class II - Special Controls.

Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on February 24, 2012 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3300 - 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 Meridian Bioscience, Inc. devices

FDA 510(k) Submission Details - K113190

510(k) Number K113190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2011
Decision Date February 24, 2012
Days to Decision 116 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
14d slower than avg
Panel avg: 102d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MJH Device Classification - Class 2, Special Controls

Product Code MJH Legionella, Spp., Elisa
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3300
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 - MJH Legionella, Spp., Elisa

Devices cleared under the same product code (MJH) and FDA review panel - the closest regulatory comparables to K113190.
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BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522
K982238 · Binax, Inc. · Aug 1998
BINAX LEGIONELLA URINARY ANTIGEN EIA
K934965 · Binax, Inc. · Sep 1994
LEGIONELLA STAT IGG/IGM TEST KIT
K911356 · Whittaker Bioproducts, Inc. · Jul 1992