Cleared Traditional

K091766 - CLEARVIEW EXACT PBP2A TEST, MODEL 891-000

K091766 is an FDA 510(k) clearance for CLEARVIEW EXACT PBP2A TEST, manufactured by Binax, Inc.. The device is a Class 2 Microbiology device with product code MYI cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K091766 · Binax, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
252d
Days
Class 2
Risk

K091766 is an FDA 510(k) clearance for the CLEARVIEW EXACT PBP2A TEST, MODEL 891-000. Classified as System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies (product code MYI), Class II - Special Controls.

Submitted by Binax, Inc. (Scarborough, US). The FDA issued a Cleared decision on February 24, 2010 after a review of 252 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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 - K091766

510(k) Number K091766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2009
Decision Date February 24, 2010
Days to Decision 252 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
150d slower than avg
Panel avg: 102d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MYI Device Classification - Class 2, Special Controls

Product Code MYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
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 - MYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies

Devices cleared under the same product code (MYI) and FDA review panel - the closest regulatory comparables to K091766.
ALERE PBP2A SA/CONS CULTURE COLONY TEST
K133851 · Alere Scarborough, Inc. · Sep 2014
ALERE PBP2A TEST
K121905 · Alere Scarborough, Inc. · Jul 2012
BINAXNOW PBP2A TEST, MODEL 890-000
K090301 · Binax, Inc. · Apr 2010
OXOID PBP2 1 LATEX AGGLUTINATION TEST
K011710 · Oxoid , Ltd. · Apr 2002
VELOGENE RAPID MRSA IDENTIFICATION ASSAY
K990640 · Id Biomedical Corp. · Jul 1999