510(k) · Cleared
ClearedAxis-Shield 3-Reagent Homocysteine Assay for Synchron
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axis-Shield Diagnostics, Ltd. · LPS Urinary Homocystine (Nonquantitative) Test System
Cleared on May 7, 2012 as substantially equivalent to K083222 (Axis-Shield Diagnostics, Ltd., 2009) after a 224-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- May 7, 2012
- Review
- 224 days
- Class
- Class II
- Product code
- LPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011689 (2001). No later device cites it as a predicate yet.
- Root · 3 generations backK011689 Homogeneous Enzymic Homocysteine ReagentCatch, Inc. · 2001 · Recalled
- 2 generations backK062808 Liquid Stable (LS) 2-Part Homocysteine ReagentCatch Incorporated · 2006
- 1 generation backK083222 Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent, Model…Axis-Shield Diagnostics, Ltd. · 2009 · Recalled
- This deviceK112790 Axis-Shield 3-Reagent Homocysteine Assay for SynchronAxis-Shield Diagnostics, Ltd. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011689 | Homogeneous Enzymic Homocysteine Reagent | Catch, Inc. | 2001 | 1 |
| −2 | K062808 | Liquid Stable (LS) 2-Part Homocysteine Reagent | Catch Incorporated | 2006 | — |
| −1 | K083222 | Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent, Model FHRK100 | Axis-Shield Diagnostics, Ltd. | 2009 | 5 |
| 0 (this device) | K112790 | Axis-Shield 3-Reagent Homocysteine Assay for Synchron | Axis-Shield Diagnostics, Ltd. | 2012 | — |
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 |
|---|---|---|---|
| * | K083222 | Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent, Model FHRK100Summary page 1…cation Panel: Clinical Chemistry Product Code: LPS Legally marketed device to which equivalency is claimed: Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent (k083222) Intended Use of Device: 'systems is lintended for in vitro quantitative determiniation of totaL homocysteine in… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 3 ancestors have a recall of any class.
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. 2012, this device’s year, is highlighted.
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?
The 3-Reagent Homocysteine Assay for Beckman Coulter SYNCHRON® and UniCel® systems is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemnia and homocysturia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112790 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112790: Axis-Shield 3-Reagent Homocysteine Assay for Synchron.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112790
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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