Cleared Traditional

K981829 - IS EBV-EBNA-1 IGG ELISA TEST SYSTEM

K981829 is an FDA 510(k) clearance for IS EBV-EBNA-1 IGG ELISA TEST SYSTEM, manufactured by Diamedix Corp.. The device is a Class 1 Microbiology device with product code GNP cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K981829 · Diamedix Corp. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
270d
Days
Class 1
Risk

K981829 is an FDA 510(k) clearance for the IS EBV-EBNA-1 IGG ELISA TEST SYSTEM. Classified as Antiserum, Cf, Epstein-barr Virus (product code GNP), Class I - General Controls.

Submitted by Diamedix Corp. (Columbia, US). The FDA issued a Cleared decision on February 16, 1999 after a review of 270 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.

FDA 510(k) Submission Details - K981829

510(k) Number K981829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1998
Decision Date February 16, 1999
Days to Decision 270 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
168d slower than avg
Panel avg: 102d · This submission: 270d
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 19
Devices cleared under the same product code (GNP) and FDA review panel - the closest regulatory comparables to K981829.
EBV-VCA IGG ELISA TEST, MODEL EBG-100
K020706 · Pan Bio Pty. , Ltd. · Jun 2002
EBV-EBNA IGG ELISA KIT, MODEL EBG-100
K020707 · Pan Bio Pty. , Ltd. · Jun 2002
EBV V VCA IGM ELISA KIT MODEL# EBM-200
K020717 · Pan Bio Pty. , Ltd. · Jun 2002
IS EBV-EA-D IGG ELISA TEST SYSTEM
K981831 · Diamedix Corp. · Feb 1999
EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM
K901156 · Granbio, Inc. · Sep 1990
SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI
K883670 · Electro-Nucleonics, Inc. · Apr 1989
K981829 · IS EBV-EBNA-1 IGG ELISA TEST SYSTEM
Download PDF FDA Summary Diamedix Corp.