Cleared Traditional

K160650 - LIAISON HAV IgM, LIAISON Control HAV IgM

K160650 is an FDA 510(k) clearance for LIAISON HAV IgM, 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 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

FDA 510(k) Submission Details - K160650

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.

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 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