Cleared Traditional

K133851 - ALERE PBP2A SA/CONS CULTURE COLONY TEST

K133851 is an FDA 510(k) clearance for ALERE PBP2A SA/CONS CULTURE COLONY TEST, manufactured by Alere Scarborough, Inc.. The device is a Class 2 Microbiology device with product code MYI cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K133851 · Alere Scarborough, Inc. · Microbiology device
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Sep 2014
Decision
258d
Days
Class 2
Risk

K133851 is an FDA 510(k) clearance for the ALERE PBP2A SA/CONS CULTURE COLONY 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 September 3, 2014 after a review of 258 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 Alere Scarborough, Inc. devices

FDA 510(k) Submission Details - K133851

510(k) Number K133851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2013
Decision Date September 03, 2014
Days to Decision 258 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
156d slower than avg
Panel avg: 102d · This submission: 258d
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 K133851.
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