Cleared Traditional

K033051 - LEGIONELLA PNEUMOPHILA IGG/IGM

K033051 is an FDA 510(k) clearance for LEGIONELLA PNEUMOPHILA IGG/IGM, manufactured by Trinity Biotech USA. The device is a Class 2 Microbiology device with product code MJH cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K033051 · Trinity Biotech USA · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
58d
Days
Class 2
Risk

K033051 is an FDA 510(k) clearance for the LEGIONELLA PNEUMOPHILA IGG/IGM. Classified as Legionella, Spp., Elisa (product code MJH), Class II - Special Controls.

Submitted by Trinity Biotech USA (Jamestown, US). The FDA issued a Cleared decision on November 26, 2003 after a review of 58 days - a notably fast clearance cycle.

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: 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 Trinity Biotech USA devices

FDA 510(k) Submission Details - K033051

510(k) Number K033051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2003
Decision Date November 26, 2003
Days to Decision 58 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 102d · This submission: 58d
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 7
Devices cleared under the same product code (MJH) and FDA review panel - the closest regulatory comparables to K033051.
ImmuView S pneumoniae and L pneumophila Urinary Antigen Test
K191184 · Ssi Diagnostica A/S · Mar 2020
TRU Legionella
K163273 · Meridian Bioscience, Inc. · Feb 2017
TRU LEGIONELLA
K113190 · Meridian Bioscience, Inc. · Feb 2012
BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST
K991074 · Intracel Corp. · Dec 1999
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