Cleared Traditional

K931443 - ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG AN...

K931443 is the FDA 510(k) clearance for ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG AN... by Ortho Diagnostic Systems, Inc.. It is a Class 1 Microbiology device (product code LSE) cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K931443 · Ortho Diagnostic Systems, Inc. · Microbiology device
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Nov 1993
Decision
228d
Days
Class 1
Risk

K931443 is an FDA 510(k) clearance for the ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS. Classified as Epstein-barr Virus, Other (product code LSE), Class I - General Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on November 5, 1993 after a review of 228 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 K931443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1993
Decision Date November 05, 1993
Days to Decision 228 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
126d slower than avg
Panel avg: 102d · This submission: 228d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LSE Epstein-barr Virus, Other
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 - LSE Epstein-barr Virus, Other

All 23
Devices cleared under the same product code (LSE) and FDA review panel - the closest regulatory comparables to K931443.
EBV LGG ELISA TEST
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K946157 · Incstar Corp. · Jun 1995
INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) IGG ELISA KIT
K946159 · Incstar Corp. · Jun 1995
EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA
K921628 · Incstar Corp. · Sep 1992
BARTELS EPSTEIN-BARR VIRUS IGG EIA
K922332 · Baxter Diagnostics, Inc. · Sep 1992
FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS
K912488 · Immuno Concepts, Inc. · Jul 1991