510(k) · Cleared
Recalled · Class II · 2025Advia Centaur Homocysteine Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Diagnostics Corp. · LPS Urinary Homocystine (Nonquantitative) Test System
Cleared on Dec 18, 2001 as substantially equivalent to K992858 (Abbott Laboratories, 1999) after a 64-day review. Its family tree reaches back 1 generation to 1999. It has been recalled 2 times.
- Decided
- Dec 18, 2001
- Review
- 64 days
- Class
- Class II
- Product code
- LPS
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992858 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK992858 Abbott Axsym HomocysteineAbbott Laboratories · 1999 · Recalled
- This deviceK013406 Advia Centaur Homocysteine AssayBayer Diagnostics Corp. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992858 | Abbott Axsym Homocysteine | Abbott Laboratories | 1999 | 1 |
| 0 (this device) | K013406 | Advia Centaur Homocysteine Assay | Bayer Diagnostics Corp. | 2001 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LPS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992858 | Abbott Axsym HomocysteineSummary page 1…turer: Manufactured by: Axis-Shield ASA Ulvenveien 87 N-0581 Oslo, Norway Manufactured for: Abbott Laboratories Abbott Park Road 510(k) Number: Abbott Park, Il. 60064 K 992858 4. Device Description The ADVIA Centaur HCY assay is a competitive immunoassay using direct, chemiluminescent te… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 15, 2025 | Class II | Z-1822-2025 | Under Investigation by firm | 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. |
| Jun 25, 2013 | Class II | Z-1960-2014 | Device Design | 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). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 4 other devices also cite its predicate K992858.
How does its category compare?
All LPS devicesLPS Urinary Homocystine (Nonquantitative) Test System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPS
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · LPS
141in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPS
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPS
1in 2024
MAUDE reports naming product code LPS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 1 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 0 |
| 2012 | 4 | 141 | 1 | 0 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 8 |
| 2018 | 0 | — | 1 | 0 |
| 2019 | 0 | — | 4 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 1 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or EDTA plasma using the ADVIA Centaur® System. This diagnostic test is designed to quantitatively measure HCY in serum or EDTA plasma. Such measurement can aid in the diagnosis and treatment of patients suspected of having homocysteinuria or hyperhomocysteinemia.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013406 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013406: Advia Centaur Homocysteine Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013406
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026