Cleared Traditional

K083744 - BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010

K083744 is an FDA 510(k) clearance for BINAXNOW MALARIA POSITIVE CONTROL KIT, manufactured by Binax, Inc.. The device is a Class 1 Microbiology device with product code MJZ cleared through the Traditional 510(k) pathway after a 259-day FDA review.

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

FDA 510(k) Submission Details - K083744

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 102d · This submission: 259d
Pathway characteristics
Predicate-based equivalence.

MJZ Device Classification - Class 1, General Controls

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.