Cleared Traditional

K855236 - DIAGNOSTIC REAGENT TST-RPLA

K855236 is an FDA 510(k) clearance for DIAGNOSTIC REAGENT TST-RPLA, manufactured by Oxoid U.S.A., Inc.. The device is a Class 1 Microbiology device with product code GTN cleared through the Traditional 510(k) pathway after a 308-day FDA review.

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

FDA 510(k) Submission Details - K855236

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
206d slower than avg
Panel avg: 102d · This submission: 308d
Pathway characteristics
Predicate-based equivalence.

GTN Device Classification - Class 1, General Controls

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.