Cleared Traditional

K930002 - ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA

K930002 is an FDA 510(k) clearance for ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIB..., manufactured by Ortho Diagnostic Systems, Inc.. The device is a Class 1 Microbiology device with 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

FDA 510(k) Submission Details - K930002

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.

LLM Device Classification - Class 1, General Controls

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 21
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
EBNA STAT TEST KIT
K911473 · Whittaker Bioproducts, Inc. · Sep 1991
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