Cleared Traditional

K020717 - EBV V VCA IGM ELISA KIT MODEL# EBM-200

K020717 is an FDA 510(k) clearance for EBV V VCA IGM ELISA KIT MODEL# EBM-200, manufactured by Pan Bio Pty. , Ltd.. The device is a Class 1 Microbiology device with product code GNP cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K020717 · Pan Bio Pty. , Ltd. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K020717

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.

GNP Device Classification - Class 1, General Controls

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.

Regulatory Peers - GNP Antiserum, Cf, Epstein-barr Virus

All 11
Devices cleared under the same product code (GNP) and FDA review panel - the closest regulatory comparables to K020717.
IS EBV-EBNA-1 IGG ELISA TEST SYSTEM
K981829 · Diamedix Corp. · Feb 1999
IS EBV-EA-D IGG ELISA TEST SYSTEM
K981831 · Diamedix Corp. · Feb 1999
EBV-VCA ANTIBODY (IGG)
K884591 · Hillcrest Biologicals · Jan 1989
EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT)
K880883 · Immuno Concepts, Inc. · Aug 1988
EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME)
K880885 · Immuno Concepts, Inc. · Aug 1988
EBV-CHECK(TM) TEST KIT (IGG)
K871373 · Diagnostic Technology, Inc. · Jun 1987