510(k) · Cleared

Recalled · 2003

Abbott Axsym Homocysteine

K992858510(k) TraditionalCleared Oct 25, 199961-day reviewClass II21 CFR 862.1377Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Abbott Laboratories · LPS Urinary Homocystine (Nonquantitative) Test System

Cleared on Oct 25, 1999 after a 61-day review. The FDA summary names its predicate without a number. 9 later devices descend from it. It has been recalled once.

Decided: Oct 25, 1999
Review: 61 days
Class: Class II
Product code: LPS
Recalls: 1
Predicates: 0

9 later devices descend from it, 5 citing it directly.

This deviceK992858 Abbott Axsym HomocysteineAbbott Laboratories · 1999
Descendant · cites it directly · 4 of its ownK052788 N Latex Hcy, N Protein Standard SL, N/T Protein Control L/M/HDade Behring, Inc. · 2006 · Recalled
Descendant · 2 generations on · 1 of its ownK063206 Dimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator…Dade Behring, Inc. · 2006 · Recalled
Descendant · 2 generations on · 0 of its ownK110874 Advia Chemistry Reagents, and Advia Chemistry B2-Microglobulin…Siemens Healthcare Diagnostics, Inc. · 2012
Descendant · 2 generations on · 0 of its ownK083463 Dimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1…Siemens Healthcare Diagnostics · 2009 · Recalled
Descendant · cites it directly · 0 of its ownK073640 Architect Homocysteine Reagents, Calibrators and ControlsAxis-Shield Diagnostics, Ltd. · 2008

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2001high 3 (2006) · low 0 (2002)2026

Most influential descendants

Showing 5 of 9 · See all

K052788N Latex Hcy, N Protein Standard SL, N/T Protein Control L/M/HDade Behring, Inc. · 2006 · cites it directly4descendants
K063206Dimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator; Protein 1 Control…Dade Behring, Inc. · 2006 · 2 generations on1descendant
K110874Advia Chemistry Reagents, and Advia Chemistry B2-Microglobulin CalibratorSiemens Healthcare Diagnostics, Inc. · 2012 · 2 generations on0descendants
K083463Dimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1 Calibrator, Dimension…Siemens Healthcare Diagnostics · 2009 · 2 generations on0descendants
K073640Architect Homocysteine Reagents, Calibrators and ControlsAxis-Shield Diagnostics, Ltd. · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K992858	Abbott Axsym Homocysteine	Abbott Laboratories	1999	—
+1	K052788	N Latex Hcy, N Protein Standard SL, N/T Protein Control L/M/H	Dade Behring, Inc.	2006	2
+2	K063206	Dimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator; Protein 1…	Dade Behring, Inc.	2006	3
+2	K110874	Advia Chemistry Reagents, and Advia Chemistry B2-Microglobulin Calibrator	Siemens Healthcare Diagnostics, Inc.	2012	—
+2	K083463	Dimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1 Calibrator…	Siemens Healthcare Diagnostics	2009	4
+1	K073640	Architect Homocysteine Reagents, Calibrators and Controls	Axis-Shield Diagnostics, Ltd.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	2	0
2006	3	0
2007	1	0
2008	1	0
2009	1	0
2012	1	0

FIG. 1 — Lineage of K992858, 1999–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	—	Abbott IMx® Homocysteine assay Named without a submission number			—

What descends from it? (9)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K052788	N Latex Hcy, N Protein Standard SL, N/T Protein Control L/M/H	Dade Behring, Inc.	2006	4
K073640	Architect Homocysteine Reagents, Calibrators and Controls	Axis-Shield Diagnostics, Ltd.	2008	0
K061598	Hemosil Homocysteine and Controls	Instrumentation Laboratory CO	2006	0
K013606	Acs 180 Homocysteine Assay	Bayer Diagnostics Corp.	2001	0
K013406	Advia Centaur Homocysteine Assay	Bayer Diagnostics Corp.	2001	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 22, 2003	Not classified	Z-1218-03	Other	There is a kit-to-kit difference within the lots, with the reagents generating different polarization values than those in others.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K052788 (Dade Behring, Inc., 2006) has gone furthest, with 4 descendants of its own.

How does its category compare?

All LPS devices

LPS Urinary Homocystine (Nonquantitative) Test System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LPS

1in 2013

2007high 4 (2012) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPS

141in 2012

2007high 141 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPS

1in 2024

2007high 4 (2019) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPS

1in 2024

2007high 8 (2017) · low 0 (2007)2025

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?

The AxSYM" Homocysteine assay is a Fluorescence Polarization Immunoassay

(FPIA) for the quantitative measurement of total L-homocysteine in human serum

or plasma on the AXSYM System. Homocysteine values can assist in the

diagnosis and treatment of patients suspected of having hyperhomocysteinemia

and homocystinuria.

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/K992858 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992858: Abbott Axsym Homocysteine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992858

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026