Cleared Special

K121905 - ALERE PBP2A TEST (FDA 510(k) Clearance)

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

K121905 · Alere Scarborough, Inc. · Microbiology device
Jul 2012
Decision
27d
Days
Class 2
Risk

K121905 is an FDA 510(k) clearance for the ALERE PBP2A TEST. Classified as System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies (product code MYI), Class II - Special Controls.

Submitted by Alere Scarborough, Inc. (Scarborough, US). The FDA issued a Cleared decision on July 26, 2012 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K121905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2012
Decision Date July 26, 2012
Days to Decision 27 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
147d faster than avg
Panel avg: 174d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.