Cleared Traditional

K924091 - EBV-VCA IGG ELISA TEST SYSTEM (FDA 510(k) Clearance)

Class I Microbiology device.

K924091 · Zeus Scientific, Inc. · Microbiology device
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Jan 1993
Decision
151d
Days
Class 1
Risk

K924091 is an FDA 510(k) clearance for the EBV-VCA IGG ELISA TEST SYSTEM. Classified as Antigen, Ebv, Capsid (product code MCD), Class I - General Controls.

Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on January 11, 1993 after a review of 151 days - an extended review cycle.

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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K924091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1992
Decision Date January 11, 1993
Days to Decision 151 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
49d slower than avg
Panel avg: 102d · This submission: 151d
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.