Cleared Traditional

EBV V VCA IGM ELISA KIT MODEL# EBM-200 (K020717) - FDA 510(k) Clearance

Class I Microbiology device.

K020717 · Pan Bio Pty. , Ltd. · Microbiology device
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Jun 2002
Decision
100d
Days
Class 1
Risk

K020717 is an FDA 510(k) clearance for the EBV V VCA IGM ELISA KIT MODEL# EBM-200. Classified as Antiserum, Cf, Epstein-barr Virus (product code GNP), Class I - General Controls.

Submitted by Pan Bio Pty. , Ltd. (Windsor, AU). The FDA issued a Cleared decision on June 13, 2002 after a review of 100 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 Pan Bio Pty. , Ltd. devices

Submission Details

510(k) Number K020717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2002
Decision Date June 13, 2002
Days to Decision 100 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
2d faster than avg
Panel avg: 102d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GNP Antiserum, Cf, 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.