Cleared Traditional

K190428 - Elecsys Anti-HAV II

K190428 is an FDA 510(k) clearance for Elecsys Anti-HAV II, manufactured by Roche Diagnostics. The device is a Class 2 Microbiology device with product code LOL cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K190428 · Roche Diagnostics · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2019
Decision
172d
Days
Class 2
Risk

K190428 is an FDA 510(k) clearance for the Elecsys Anti-HAV II. Classified as Hepatitis A Test (antibody And Igm Antibody) (product code LOL), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on August 13, 2019 after a review of 172 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 Roche Diagnostics devices

FDA 510(k) Submission Details - K190428

510(k) Number K190428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2019
Decision Date August 13, 2019
Days to Decision 172 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
70d slower than avg
Panel avg: 102d · This submission: 172d
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 K190428.
LIAISON Anti-HAV
K223403 · DiaSorin, Inc. · Dec 2022
LIAISON Anti-HAV
K210272 · DiaSorin, Inc. · Feb 2021
LIAISON Anti-HAV Assay
K193532 · DiaSorin, Inc. · Mar 2020
ADVIA Centaur HAV IgM Assay
K161964 · Siemens Healthcare Diagnostics, Inc. · Oct 2016
LIAISON HAV IgM, LIAISON Control HAV IgM
K160650 · DiaSorin, Inc. · Aug 2016
ADVIA Centaur HAV total assay
K142758 · Siemens Healthcare Diagnostics, Inc. · Dec 2014