Cleared Traditional

OXOID PBP2 1 LATEX AGGLUTINATION TEST (K011710) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K011710 · Oxoid , Ltd. · Microbiology device
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Apr 2002
Decision
302d
Days
Class 2
Risk

K011710 is an FDA 510(k) clearance for the OXOID PBP2 1 LATEX AGGLUTINATION TEST. Classified as System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies (product code MYI), Class II - Special Controls.

Submitted by Oxoid , Ltd. (Basingstoke, GB). The FDA issued a Cleared decision on April 2, 2002 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K011710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2001
Decision Date April 02, 2002
Days to Decision 302 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
200d slower than avg
Panel avg: 102d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.