Cleared Traditional

K930020 - ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA

K930020 is an FDA 510(k) clearance for ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBO..., manufactured by Ortho Diagnostic Systems, Inc.. The device is a Class 1 Microbiology device with product code LJN cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K930020 · Ortho Diagnostic Systems, Inc. · Microbiology device
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Jul 1993
Decision
193d
Days
Class 1
Risk

K930020 is an FDA 510(k) clearance for the ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA. Classified as Antibody Igm, If, Epstein-barr Virus (product code LJN), Class I - General Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on July 16, 1993 after a review of 193 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.

View all Ortho Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K930020

510(k) Number K930020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1993
Decision Date July 16, 1993
Days to Decision 193 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
91d slower than avg
Panel avg: 102d · This submission: 193d
Pathway characteristics
Predicate-based equivalence.

LJN Device Classification - Class 1, General Controls

Product Code LJN Antibody Igm, If, Epstein-barr Virus
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 - LJN Antibody Igm, If, Epstein-barr Virus

All 15
Devices cleared under the same product code (LJN) and FDA review panel - the closest regulatory comparables to K930020.
SERAQUEST EB VAC IGM
K990977 · Quest Intl., Inc. · Oct 1999
COPALIS EBV-M ANTIBODY ASSAY
K991459 · DiaSorin, Inc. · May 1999
IMMUNOWELL VCA IGM TEST
K973939 · Genbio · Aug 1998
BARTELS EPSTEIN-BARR VIRUS IGM EIA
K922331 · Baxter Diagnostics, Inc. · Sep 1992
EBV IGM ELISA TEST
K910042 · Gull Laboratories, Inc. · Feb 1991
EBV VCA ANTIBODY (IGM)
K896594 · Hillcrest Biologicals · Jan 1990