Cleared Traditional

K082050 - LIAISON HAV IGM ASSAY

K082050 is the FDA 510(k) clearance for LIAISON HAV IGM ASSAY by DiaSorin, Inc.. It is a Class 2 Microbiology device (product code LOL) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K082050 · DiaSorin, Inc. · Microbiology device
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Nov 2008
Decision
108d
Days
Class 2
Risk

K082050 is an FDA 510(k) clearance for the LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM. Classified as Hepatitis A Test (antibody And Igm Antibody) (product code LOL), Class II - Special Controls.

Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on November 3, 2008 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3310 - 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 DiaSorin, Inc. devices

Submission Details

510(k) Number K082050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2008
Decision Date November 03, 2008
Days to Decision 108 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
6d slower than avg
Panel avg: 102d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LOL Hepatitis A Test (antibody And Igm Antibody)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3310
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - LOL Hepatitis A Test (antibody And Igm Antibody)

All 24
Devices cleared under the same product code (LOL) and FDA review panel - the closest regulatory comparables to K082050.
MONOLISA ANTI-HAV IGM EIA
K092353 · Bio-Rad Laboratories, Inc. · Oct 2009
MONOLISA ANTI-HAV EIA
K092355 · Bio-Rad Laboratories, Inc. · Oct 2009
LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV
K082049 · DiaSorin, Inc. · Dec 2008
ADVIA CENTAUR HAVM ASSAY
K081716 · Siemens Healthcare Diagnostics, Inc. · Jul 2008
MONOLISA ANTI-HAV EIA
K063318 · Bio-Rad Laboratories · May 2007
MONOLISA ANTI-HAV IGM EIA
K063319 · Bio-Rad Laboratories · May 2007