Cleared Traditional

K030863 - EBV VCA-P18 IGG ELISA

K030863 is an FDA 510(k) clearance for EBV VCA-P18 IGG ELISA, manufactured by Panbio Limited. The device is a Class 1 Microbiology device with product code LSE cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K030863 · Panbio Limited · Microbiology device
Download Printable Device Report (PDF)
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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.

View all Panbio Limited devices

FDA 510(k) Submission Details - K030863

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.

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 48
Devices cleared under the same product code (LSE) and FDA review panel - the closest regulatory comparables to K030863.
BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
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MODIFICATION TO SERAQUEST EB VCA IGG
K033915 · Quest Intl., Inc. · Jan 2004
EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM
K992587 · Stellar Bio Systems, Inc. · Dec 1999
SERAQUEST EB NA IGG
K991975 · Quest Intl., Inc. · Nov 1999
SERAQUEST EB VCA IGG
K990410 · Quest Intl., Inc. · Oct 1999