Cleared Traditional

COPALIS EBV-M ANTIBODY ASSAY (K991459) - FDA 510(k) Clearance

Class I Microbiology device.

K991459 · DiaSorin, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
18d
Days
Class 1
Risk

K991459 is an FDA 510(k) clearance for the COPALIS EBV-M ANTIBODY ASSAY. Classified as Antibody Igm, If, Epstein-barr Virus (product code LJN), Class I - General Controls.

Submitted by DiaSorin, Inc. (Columbia, US). The FDA issued a Cleared decision on May 14, 1999 after a review of 18 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all DiaSorin, Inc. devices

Submission Details

510(k) Number K991459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1999
Decision Date May 14, 1999
Days to Decision 18 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 102d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

Device Classification

Product Code LJN Antibody Igm, If, 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.