Cleared Traditional

K934965 - BINAX LEGIONELLA URINARY ANTIGEN EIA

K934965 is an FDA 510(k) clearance for BINAX LEGIONELLA URINARY ANTIGEN EIA, manufactured by Binax, Inc.. The device is a Class 2 Microbiology device with product code MJH cleared through the Traditional 510(k) pathway after a 340-day FDA review.

K934965 · Binax, Inc. · Microbiology device
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Sep 1994
Decision
340d
Days
Class 2
Risk

K934965 is an FDA 510(k) clearance for the BINAX LEGIONELLA URINARY ANTIGEN EIA. Classified as Legionella, Spp., Elisa (product code MJH), Class II - Special Controls.

Submitted by Binax, Inc. (Portland, US). The FDA issued a Cleared decision on September 20, 1994 after a review of 340 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Binax, Inc. devices

FDA 510(k) Submission Details - K934965

510(k) Number K934965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1993
Decision Date September 20, 1994
Days to Decision 340 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
238d slower than avg
Panel avg: 102d · This submission: 340d
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 K934965.
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
LEGIONELLA STAT IGG/IGM TEST KIT
K911356 · Whittaker Bioproducts, Inc. · Jul 1992