Cleared Traditional

K911571 - EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST (FDA 510(k) Clearance)

Class I Microbiology device.

K911571 · Ortho Diagnostic Systems, Inc. · Microbiology device
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Jun 1991
Decision
63d
Days
Class 1
Risk

K911571 is an FDA 510(k) clearance for the EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST. Classified as Antigen, Ebv, Capsid (product code MCD), Class I - General Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on June 10, 1991 after a review of 63 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ortho Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K911571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1991
Decision Date June 10, 1991
Days to Decision 63 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 102d · This submission: 63d
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.