Cleared Traditional

K931443 - ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS

K931443 is an FDA 510(k) clearance for ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG AN..., manufactured by Ortho Diagnostic Systems, Inc.. The device is a Class 1 Microbiology device with 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

FDA 510(k) Submission Details - K931443

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.

LSE Device Classification - Class 1, General Controls

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 47
Devices cleared under the same product code (LSE) and FDA review panel - the closest regulatory comparables to K931443.
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