Cleared Traditional

K933251 - EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST

K933251 is an FDA 510(k) clearance for EPSTEIN-BARR VIRUS COMBI TEST, manufactured by Virion (U.S.), Inc.. The device is a Class 1 Microbiology device with product code MCD cleared through the Traditional 510(k) pathway after a 346-day FDA review.

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

FDA 510(k) Submission Details - K933251

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.

MCD Device Classification - Class 1, General Controls

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.

Regulatory Peers - MCD Antigen, Ebv, Capsid

Devices cleared under the same product code (MCD) and FDA review panel - the closest regulatory comparables to K933251.
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