Cleared Special

K210272 - LIAISON Anti-HAV

K210272 is an FDA 510(k) clearance for LIAISON Anti-HAV, manufactured by DiaSorin, Inc.. The device is a Class 2 Microbiology device with product code LOL cleared through the Special 510(k) pathway after a 8-day FDA review.

K210272 · DiaSorin, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2021
Decision
8d
Days
Class 2
Risk

K210272 is an FDA 510(k) clearance for the LIAISON Anti-HAV. 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 February 9, 2021 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3310 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K210272

510(k) Number K210272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2021
Decision Date February 09, 2021
Days to Decision 8 days
Submission Type Special
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
94d faster than avg
Panel avg: 102d · This submission: 8d
Pathway characteristics
Modification to existing cleared device.

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 25
Devices cleared under the same product code (LOL) and FDA review panel - the closest regulatory comparables to K210272.
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LIAISON Anti-HAV
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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
K210272 · LIAISON Anti-HAV
Download PDF FDA Summary DiaSorin, Inc.