Cleared Traditional

K160650 - LIAISON HAV IgM

K160650 is the FDA 510(k) clearance for LIAISON HAV IgM by DiaSorin, Inc.. It is a Class 2 Microbiology device (product code LOL) cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K160650 · DiaSorin, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
170d
Days
Class 2
Risk

K160650 is an FDA 510(k) clearance for the LIAISON HAV IgM, 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 August 25, 2016 after a review of 170 days - an extended review cycle.

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 K160650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2016
Decision Date August 25, 2016
Days to Decision 170 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
68d slower than avg
Panel avg: 102d · This submission: 170d
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 22
Devices cleared under the same product code (LOL) and FDA review panel - the closest regulatory comparables to K160650.
LIAISON Anti-HAV Assay
K193532 · DiaSorin, Inc. · Mar 2020
Elecsys Anti-HAV II
K190428 · Roche Diagnostics · Aug 2019
ADVIA Centaur HAV IgM Assay
K161964 · Siemens Healthcare Diagnostics, Inc. · Oct 2016
ADVIA Centaur HAV total assay
K142758 · Siemens Healthcare Diagnostics, Inc. · Dec 2014
LIAISON XL ANALYZER
K141116 · DiaSorin, Inc. · Jul 2014
ARCHITECT HAVAB-G
K113704 · Abbott Laboratories · Jun 2012