Cleared Traditional

BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 (K083744) - FDA 510(k) Clearance

Class I Microbiology device.

K083744 · Binax, Inc. · Microbiology device
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Sep 2009
Decision
259d
Days
Class 1
Risk

K083744 is an FDA 510(k) clearance for the BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010. Classified as Kit, Direct Antigen, Positive Control (product code MJZ), Class I - General Controls.

Submitted by Binax, Inc. (Scarborough, US). The FDA issued a Cleared decision on September 1, 2009 after a review of 259 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.1660 - 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. Standard predicate reliance. 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

Submission Details

510(k) Number K083744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2008
Decision Date September 01, 2009
Days to Decision 259 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
157d slower than avg
Panel avg: 102d · This submission: 259d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MJZ Kit, Direct Antigen, Positive Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.