Cleared Traditional

K930002 - ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIB...

K930002 is the FDA 510(k) clearance for ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIB... by Ortho Diagnostic Systems, Inc.. It is a Class 1 Microbiology device (product code LLM) cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K930002 · Ortho Diagnostic Systems, Inc. · Microbiology device
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Jul 1993
Decision
193d
Days
Class 1
Risk

K930002 is an FDA 510(k) clearance for the ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA. Classified as Test, Antigen, Nuclear, Epstein-barr Virus (product code LLM), 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

Submission Details

510(k) Number K930002 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.

Device Classification

Product Code LLM Test, Antigen, Nuclear, 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 - LLM Test, Antigen, Nuclear, Epstein-barr Virus

All 12
Devices cleared under the same product code (LLM) and FDA review panel - the closest regulatory comparables to K930002.
EBNA IGG ELISA TEST
K935730 · Gull Laboratories, Inc. · Sep 1995
INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT
K946158 · Incstar Corp. · Jun 1995
EBNA IGG ELISA TEST SYSTEM
K932742 · Zeus Scientific, Inc. · May 1995
EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST
K911569 · Ortho Diagnostic Systems, Inc. · Jun 1991
EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI)
K895708 · Immuno Concepts, Inc. · Dec 1989
EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY)
K895707 · Immuno Concepts, Inc. · Dec 1989