Cleared Traditional

K981831 - IS EBV-EA-D IGG ELISA TEST SYSTEM

K981831 is an FDA 510(k) clearance for IS EBV-EA-D 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.

K981831 · Diamedix Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
270d
Days
Class 1
Risk

K981831 is an FDA 510(k) clearance for the IS EBV-EA-D 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.

View all Diamedix Corp. devices

FDA 510(k) Submission Details - K981831

510(k) Number K981831 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 10
Devices cleared under the same product code (GNP) and FDA review panel - the closest regulatory comparables to K981831.
IS EBV-EBNA-1 IGG ELISA TEST SYSTEM
K981829 · 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
EBV/VCA-CHECK(TM) ANTIGEN SLIDES
K863408 · Diagnostic Technology, Inc. · Nov 1986