Not Cleared Post-NSE

DEN070006 - BINAX NOW MALARIA TEST (FDA 510(k) Clearance)

Also includes:
MODEL 660-000, 660-XXX

Class II Microbiology device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN070006 · Inverness Medical Professional Diagnostics-Binax · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
82d
Days
Class 2
Risk

DEN070006 is an FDA 510(k) submission (not cleared) for the BINAX NOW MALARIA TEST. Classified as Plasmodium Spp. Detection Reagents (product code OAX), Class II - Special Controls.

Submitted by Inverness Medical Professional Diagnostics-Binax (Scarborough, US). The FDA issued a Not Cleared (DENG) decision on June 13, 2007 after a review of 82 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3402 - the FDA microbiology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Microbiology review framework.

View all Inverness Medical Professional Diagnostics-Binax devices

Submission Details

510(k) Number DEN070006 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 23, 2007
Decision Date June 13, 2007
Days to Decision 82 days
Submission Type Post-NSE
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 102d · This submission: 82d
Pathway characteristics

Device Classification

Product Code OAX Plasmodium Spp. Detection Reagents
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3402
Definition For The Detection Of Plasmodium Spp. Antigens In Venous Or Capillary Whole Blood. To Aid In The Diagnosis Of Human Malaria Infections And/or To Aid In The Differential Diagnosis Of Plasmodium Falciparum Infections From Other Less Virulent Plasmodium Species.
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.