Cleared Traditional

EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST (K933251) - FDA 510(k) Clearance

Class I Microbiology device.

K933251 · Virion (U.S.), Inc. · Microbiology device
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Jun 1994
Decision
346d
Days
Class 1
Risk

K933251 is an FDA 510(k) clearance for the EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST. Classified as Antigen, Ebv, Capsid (product code MCD), Class I - General Controls.

Submitted by Virion (U.S.), Inc. (Morristown, US). The FDA issued a Cleared decision on June 13, 1994 after a review of 346 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3235 - 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 Virion (U.S.), Inc. devices

Submission Details

510(k) Number K933251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1993
Decision Date June 13, 1994
Days to Decision 346 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
244d slower than avg
Panel avg: 102d · This submission: 346d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MCD Antigen, Ebv, Capsid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3235
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.