Cleared Traditional

K013406 - ADVIA CENTAUR HOMOCYSTEINE ASSAY

K013406 is an FDA 510(k) clearance for ADVIA CENTAUR HOMOCYSTEINE ASSAY, manufactured by Bayer Diagnostics Corp.. The device is a Class 2 Chemistry device with product code LPS cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K013406 · Bayer Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
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Dec 2001
Decision
64d
Days
Class 2
Risk

K013406 is an FDA 510(k) clearance for the ADVIA CENTAUR HOMOCYSTEINE ASSAY. Classified as Urinary Homocystine (nonquantitative) Test System (product code LPS), Class II - Special Controls.

Submitted by Bayer Diagnostics Corp. (Tarrytown, US). The FDA issued a Cleared decision on December 18, 2001 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1377 - the FDA in vitro diagnostics and chemistry 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 Bayer Diagnostics Corp. devices

FDA 510(k) Submission Details - K013406

510(k) Number K013406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2001
Decision Date December 18, 2001
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 88d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPS Device Classification - Class 2, Special Controls

Product Code LPS Urinary Homocystine (nonquantitative) Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1377
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 Chemistry devices follow this clearance model.

Regulatory Peers - LPS Urinary Homocystine (nonquantitative) Test System

All 24
Devices cleared under the same product code (LPS) and FDA review panel - the closest regulatory comparables to K013406.
POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS
K033706 · Polymedco, Inc. · Feb 2004
HOMOCYSTEINE MICROTITER PLATE ASSAY
K032012 · Diazyme Laboratories · Sep 2003
ACS 180 HOMOCYSTEINE ASSAY
K013606 · Bayer Diagnostics Corp. · Dec 2001
HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
K011692 · Intersect Systems, Inc. · Jul 2001
IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2
K003597 · Diagnostic Products Corp. · Feb 2001
BIO-RAD HOMOCYSTEINE BY HPLC
K993107 · Bio-Rad · Dec 1999