Cleared Traditional

K030863 - EBV VCA-P18 IGG ELISA (FDA 510(k) Clearance)

Class I Microbiology device.

K030863 · Panbio Limited · Microbiology device
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Optimized for regulatory review, auditing and printing
Jun 2003
Decision
101d
Days
Class 1
Risk

K030863 is an FDA 510(k) clearance for the EBV VCA-P18 IGG ELISA. Classified as Epstein-barr Virus, Other (product code LSE), Class I - General Controls.

Submitted by Panbio Limited (Windsor, AU). The FDA issued a Cleared decision on June 27, 2003 after a review of 101 days - within the typical 510(k) review window.

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.

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Submission Details

510(k) Number K030863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2003
Decision Date June 27, 2003
Days to Decision 101 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 102d · This submission: 101d
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.