Cleared Traditional

K161964 - ADVIA Centaur HAV IgM Assay (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K161964 · Siemens Healthcare Diagnostics, Inc. · Microbiology device
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Optimized for regulatory review, auditing and printing
Oct 2016
Decision
87d
Days
Class 2
Risk

K161964 is an FDA 510(k) clearance for the ADVIA Centaur HAV IgM Assay. Classified as Hepatitis A Test (antibody And Igm Antibody) (product code LOL), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on October 13, 2016 after a review of 87 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Siemens Healthcare Diagnostics, Inc. devices

Submission Details

510(k) Number K161964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2016
Decision Date October 13, 2016
Days to Decision 87 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 102d · This submission: 87d
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 25
Devices cleared under the same product code (LOL) and FDA review panel - the closest regulatory comparables to K161964.
Elecsys Anti-HAV IgM
K260048 · Roche Diagnostics · Apr 2026
Access anti-HAV IgM
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Access anti-HAV
K243846 · Beckman Coulter, Inc. · Sep 2025
HAVAb IgG II
K222850 · Abbott Laboratories · Aug 2023
LIAISON Anti-HAV
K223403 · DiaSorin, Inc. · Dec 2022
LIAISON Anti-HAV
K210272 · DiaSorin, Inc. · Feb 2021