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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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

All 9
Devices cleared under the same product code (MJH) and FDA review panel - the closest regulatory comparables to K113190.
ImmuView S pneumoniae and L pneumophila Urinary Antigen Test
K191184 · Ssi Diagnostica A/S · Mar 2020
TRU Legionella
K163273 · Meridian Bioscience, Inc. · Feb 2017
SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST
K061496 · Sa Scientific , Ltd. · Jun 2007
MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012
K070522 · Inverness Medical Professional Diagnostics · Mar 2007
LEGIONELLA PNEUMOPHILA IGG/IGM
K033051 · Trinity Biotech USA · Nov 2003
BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST
K991074 · Intracel Corp. · Dec 1999
K113190 · TRU LEGIONELLA
Download PDF FDA Summary Meridian Bioscience, …