Cleared Traditional

K920412 - MODIFIED ORTHO EBV VCA-IGG ELISA (FDA 510(k) Clearance)

Class I Microbiology device.

K920412 · Ortho Diagnostic Systems, Inc. · Microbiology device
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Jun 1992
Decision
143d
Days
Class 1
Risk

K920412 is an FDA 510(k) clearance for the MODIFIED ORTHO EBV VCA-IGG ELISA. 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 22, 1992 after a review of 143 days - within the typical 510(k) review window.

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.

View all Ortho Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K920412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1992
Decision Date June 22, 1992
Days to Decision 143 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 102d · This submission: 143d
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.