Cleared Traditional

COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY (K936254) - FDA 510(k) Clearance

Class I Microbiology device.

K936254 · Light Diagnostics · Microbiology device
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Sep 1995
Decision
617d
Days
Class 1
Risk

K936254 is an FDA 510(k) clearance for the COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY. Classified as Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6 (product code GNM), Class I - General Controls.

Submitted by Light Diagnostics (Temecula, US). The FDA issued a Cleared decision on September 8, 1995 after a review of 617 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3145 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

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Submission Details

510(k) Number K936254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1993
Decision Date September 08, 1995
Days to Decision 617 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
515d slower than avg
Panel avg: 102d · This submission: 617d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GNM Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3145
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.