Cleared Traditional

K082050 - LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM

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

K082050 · DiaSorin, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K082050

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.

LOL Device Classification - Class 2, Special Controls

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