Cleared Traditional

K940034 - POLIOVIRUS 2 MONOCLONAL ANTIBODY

K940034 is an FDA 510(k) clearance for POLIOVIRUS 2 MONOCLONAL ANTIBODY, manufactured by Light Diagnostics. The device is a Class 1 Microbiology device with product code GOE cleared through the Traditional 510(k) pathway after a 616-day FDA review.

K940034 · Light Diagnostics · Microbiology device
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Sep 1995
Decision
616d
Days
Class 1
Risk

K940034 is an FDA 510(k) clearance for the POLIOVIRUS 2 MONOCLONAL ANTIBODY. Classified as Antisera, Fluorescent, Poliovirus 1-3 (product code GOE), Class I - General Controls.

Submitted by Light Diagnostics (Temecula, US). The FDA issued a Cleared decision on September 12, 1995 after a review of 616 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3405 - 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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FDA 510(k) Submission Details - K940034

510(k) Number K940034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1994
Decision Date September 12, 1995
Days to Decision 616 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
514d slower than avg
Panel avg: 102d · This submission: 616d
Pathway characteristics
Predicate-based equivalence.

GOE Device Classification - Class 1, General Controls

Product Code GOE Antisera, Fluorescent, Poliovirus 1-3
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3405
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.