Cleared Traditional

K090964 - BINAXNOX STAPHYLOCOCCUS AUREUS TEST

K090964 is the FDA 510(k) clearance for BINAXNOX STAPHYLOCOCCUS AUREUS TEST by Binax, Inc.. It is a Class 1 Microbiology device (product code JWX) cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K090964 · Binax, Inc. · Microbiology device
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Dec 2009
Decision
254d
Days
Class 1
Risk

K090964 is an FDA 510(k) clearance for the BINAXNOX STAPHYLOCOCCUS AUREUS TEST. Classified as Kit, Screening, Staphylococcus Aureus (product code JWX), Class I - General Controls.

Submitted by Binax, Inc. (Scarborough, US). The FDA issued a Cleared decision on December 16, 2009 after a review of 254 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 K090964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2009
Decision Date December 16, 2009
Days to Decision 254 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
152d slower than avg
Panel avg: 102d · This submission: 254d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JWX Kit, Screening, Staphylococcus Aureus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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.

Regulatory Peers - JWX Kit, Screening, Staphylococcus Aureus

Devices cleared under the same product code (JWX) and FDA review panel - the closest regulatory comparables to K090964.
STAPH-A-LEX(TM) SYSTEM
K926173 · Trinity Laboratories, Inc. · Aug 1993
SLIDEX STAPH-KIT
K923212 · Biomerieux Vitek, Inc. · Sep 1992
AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT
K902259 · Orthomet, Inc. · Jun 1990
BACTO STAPHYLOCOCCUS LATEX TEST
K843560 · Difco Laboratories, Inc. · Oct 1984
LSM AGAR
K822558 · Granite Diagnostics, Inc. · Sep 1982
BBL STAPHYSLIDE TEST
K821962 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1982