Cleared Special

K081716 - ADVIA CENTAUR HAVM ASSAY (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K081716 · Siemens Healthcare Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
29d
Days
Class 2
Risk

K081716 is an FDA 510(k) clearance for the ADVIA CENTAUR HAVM 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 July 17, 2008 after a review of 29 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.

View all Siemens Healthcare Diagnostics, Inc. devices

Submission Details

510(k) Number K081716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2008
Decision Date July 17, 2008
Days to Decision 29 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 102d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K081716.
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K210272 · DiaSorin, Inc. · Feb 2021