Cleared Traditional

K991459 - COPALIS EBV-M ANTIBODY ASSAY

K991459 is the FDA 510(k) clearance for COPALIS EBV-M ANTIBODY ASSAY by DiaSorin, Inc.. It is a Class 1 Microbiology device (product code LJN) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

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
Combination Product No
PCCP Authorized No
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.

Regulatory Consultant

Tuv Product Service, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LJN Antibody Igm, If, Epstein-barr Virus

All 10
Devices cleared under the same product code (LJN) and FDA review panel - the closest regulatory comparables to K991459.
BIOPLEX 2200 EBV IGM KIT
K123021 · Bio-Rad Laboratories · Nov 2012
ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM
K042092 · Zeus Scientific, Inc. · Apr 2005
ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA
K930020 · Ortho Diagnostic Systems, Inc. · Jul 1993
BARTELS EPSTEIN-BARR VIRUS IGM EIA
K922331 · Baxter Diagnostics, Inc. · Sep 1992
EBV IGM ELISA TEST
K910042 · Gull Laboratories, Inc. · Feb 1991
EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME)
K880884 · Immuno Concepts, Inc. · Aug 1988