Cleared Traditional

K920412 - MODIFIED ORTHO EBV VCA-IGG ELISA

K920412 is an FDA 510(k) clearance for MODIFIED ORTHO EBV VCA-IGG ELISA, manufactured by Ortho Diagnostic Systems, Inc.. The device is a Class 1 Microbiology device with product code MCD cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K920412 · Ortho Diagnostic Systems, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K920412

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 102d · This submission: 143d
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 K920412.
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