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Advia Centaur Homocysteine Assay

by Bayer Diagnostics Corp. 510(k)

Active United States Open recall (shared submission)

510(k) K013406

Regulatory status

as of 29 Oct 2026

Recall ongoing. 1 ongoing FDA recall on shared 510(k) K013406: the recalled product is another device cleared under the same submission. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK013406 Date18 Dec 2001ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-1822-2025 FDA Class II initiated 15 Apr 2025 on shared 510(k) K013406

    Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.

    • Terminated Z-1960-2014 FDA Class II initiated 25 Jun 2013

    ADVIA Centaur Homocysteine dilution recovery on the diluent identified the percent recovery for the 1:10 patient sample dilutions lower than reported in the Instructions for Use (IFU).

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
LPS
Device Class
Class II
Regulation
21 CFR Part 862.1377
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Advia Centaur Homocysteine Assay is a competitive immunoassay using direct chemiluminescent technology, classified as a Urinary Homocystine (Nonquantitative) Test System. It quantifies the amino acid homocysteine (HCY) in serum or EDTA plasma samples, enabling clinical assessment of cardiovascular risk and metabolic disorders.

This assay is supplied as a four-reagent system, requiring sequential addition to measure total homocysteine levels. It is intended for use in clinical chemistry laboratories and has received FDA 510(k) clearance under product code LPS, classified as a Class 2 device. The system is not described as single-use or reusable in the provided data, nor is MRI safety or sterility specified.

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