Cleared Special

K070522 - MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012

K070522 is an FDA 510(k) clearance for MODIFICATION TO: BINAX NOW LEGIONELLA U..., manufactured by Inverness Medical Professional Diagnostics. The device is a Class 2 Microbiology device with product code MJH cleared through the Special 510(k) pathway after a 20-day FDA review.

K070522 · Inverness Medical Professional Diagnostics · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
20d
Days
Class 2
Risk

K070522 is an FDA 510(k) clearance for the MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012. Classified as Legionella, Spp., Elisa (product code MJH), Class II - Special Controls.

Submitted by Inverness Medical Professional Diagnostics (Scarborough, US). The FDA issued a Cleared decision on March 15, 2007 after a review of 20 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K070522

510(k) Number K070522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2007
Decision Date March 15, 2007
Days to Decision 20 days
Submission Type Special
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
82d faster than avg
Panel avg: 102d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 K070522.
TRU Legionella
K163273 · Meridian Bioscience, Inc. · Feb 2017
TRU LEGIONELLA
K113190 · Meridian Bioscience, Inc. · Feb 2012
SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST
K061496 · Sa Scientific , Ltd. · Jun 2007
LEGIONELLA PNEUMOPHILA IGG/IGM
K033051 · Trinity Biotech USA · Nov 2003
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
K070522 · MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012
Download PDF FDA Summary Inverness Medical Pro…