Cleared Traditional

K982238 - BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522

K982238 is an FDA 510(k) clearance for BINAX NOW LEGIONELLA URINARY ANTIGEN TE..., 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 57-day FDA review.

K982238 · Binax, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
57d
Days
Class 2
Risk

K982238 is an FDA 510(k) clearance for the BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG ION.... 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 August 21, 1998 after a review of 57 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 Binax, Inc. devices

FDA 510(k) Submission Details - K982238

510(k) Number K982238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1998
Decision Date August 21, 1998
Days to Decision 57 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
45d faster than avg
Panel avg: 102d · This submission: 57d
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 K982238.
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 LEGIONELLA URINARY ANTIGEN EIA
K934965 · Binax, Inc. · Sep 1994
LEGIONELLA STAT IGG/IGM TEST KIT
K911356 · Whittaker Bioproducts, Inc. · Jul 1992