Cleared Traditional

IS EBV-EBNA-1 IGG ELISA TEST SYSTEM (K981829) - FDA 510(k) Clearance

Class I Microbiology device.

K981829 · Diamedix Corp. · Microbiology device
Download Printable Device Report (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.

View all Diamedix Corp. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
168d slower than avg
Panel avg: 102d · This submission: 270d
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.