Cleared Traditional

DIAGNOSTIC REAGENT TST-RPLA (K855236) - FDA 510(k) Clearance

Class I Microbiology device.

K855236 · Oxoid U.S.A., Inc. · Microbiology device
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Nov 1986
Decision
308d
Days
Class 1
Risk

K855236 is an FDA 510(k) clearance for the DIAGNOSTIC REAGENT TST-RPLA. Classified as Antisera, Fluorescent, All Types, Staphylococcus Spp. (product code GTN), Class I - General Controls.

Submitted by Oxoid U.S.A., Inc. (Columbia, US). The FDA issued a Cleared decision on November 4, 1986 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3700 - 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.

View all Oxoid U.S.A., Inc. devices

Submission Details

510(k) Number K855236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1985
Decision Date November 04, 1986
Days to Decision 308 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
206d slower than avg
Panel avg: 102d · This submission: 308d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GTN Antisera, Fluorescent, All Types, Staphylococcus Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3700
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.