510(k) · Cleared
Recalled · 2007Homogeneous Enzymic Homocysteine Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Catch, Inc. · LPS Urinary Homocystine (Nonquantitative) Test System
Cleared on Jul 25, 2001 after a 55-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it. It has been recalled once.
- Decided
- Jul 25, 2001
- Review
- 55 days
- Class
- Class II
- Product code
- LPS
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK011689 Homogeneous Enzymic Homocysteine ReagentCatch, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK062808 Liquid Stable (LS) 2-Part Homocysteine ReagentCatch Incorporated · 2006
- Descendant · 2 generations on · 1 of its ownK083222 Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent, Model…Axis-Shield Diagnostics, Ltd. · 2009 · Recalled
- Descendant · 3 generations on · 0 of its ownK112790 Axis-Shield 3-Reagent Homocysteine Assay for SynchronAxis-Shield Diagnostics, Ltd. · 2012
Most influential descendants
Showing 3 of 3 · See all- K062808Liquid Stable (LS) 2-Part Homocysteine ReagentCatch Incorporated · 2006 · cites it directly2descendants
- K083222Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent, Model FHRK100Axis-Shield Diagnostics, Ltd. · 2009 · 2 generations on1descendant
- K112790Axis-Shield 3-Reagent Homocysteine Assay for SynchronAxis-Shield Diagnostics, Ltd. · 2012 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011689 | Homogeneous Enzymic Homocysteine Reagent | Catch, Inc. | 2001 | — |
| +1 | K062808 | Liquid Stable (LS) 2-Part Homocysteine Reagent | Catch Incorporated | 2006 | — |
| +2 | K083222 | Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent, Model FHRK100 | Axis-Shield Diagnostics, Ltd. | 2009 | 5 |
| +3 | K112790 | Axis-Shield 3-Reagent Homocysteine Assay for Synchron | Axis-Shield Diagnostics, Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062808 | Liquid Stable (LS) 2-Part Homocysteine Reagent | 2006 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 18, 2007 | Not classified | Z-0448-2009 | Device Design | A high homocysteine level can be reported as falsely low. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K062808 (Catch Incorporated, 2006) has gone furthest, with 2 descendants of its own.
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?
A homocysteine test system is an in vitro device intended to measure total homocysteine quantitatively in serum or plasma. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011689 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011689: Homogeneous Enzymic Homocysteine Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011689
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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