Cleared Traditional

K142758 - ADVIA Centaur HAV total assay

K142758 is the FDA 510(k) clearance for ADVIA Centaur HAV total assay by Siemens Healthcare Diagnostics, Inc.. It is a Class 2 Microbiology device (product code LOL) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K142758 · Siemens Healthcare Diagnostics, Inc. · Microbiology device
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Optimized for regulatory review, auditing and printing
Dec 2014
Decision
71d
Days
Class 2
Risk

K142758 is an FDA 510(k) clearance for the ADVIA Centaur HAV total 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 December 5, 2014 after a review of 71 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 K142758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2014
Decision Date December 05, 2014
Days to Decision 71 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
31d faster than avg
Panel avg: 102d · This submission: 71d
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 24
Devices cleared under the same product code (LOL) and FDA review panel - the closest regulatory comparables to K142758.
Elecsys Anti-HAV II
K190428 · Roche Diagnostics · Aug 2019
ADVIA Centaur HAV IgM Assay
K161964 · Siemens Healthcare Diagnostics, Inc. · Oct 2016
LIAISON HAV IgM, LIAISON Control HAV IgM
K160650 · DiaSorin, Inc. · Aug 2016
LIAISON XL ANALYZER
K141116 · DiaSorin, Inc. · Jul 2014
ARCHITECT HAVAB-G
K113704 · Abbott Laboratories · Jun 2012
LIAISON XL ANALYZER MODEL 10050
K103529 · DiaSorin, Inc. · Jan 2011