510(k) · Cleared
ClearedLiquid Stable (LS) 2-Part Homocysteine Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Catch Incorporated · LPS Urinary Homocystine (Nonquantitative) Test System
Cleared on Oct 13, 2006 as substantially equivalent to K011689 (Catch, Inc., 2001) after a 24-day review. Its family tree reaches back 1 generation to 2001. 2 later devices descend from it.
- Decided
- Oct 13, 2006
- Review
- 24 days
- Class
- Class II
- Product code
- LPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011689 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK011689 Homogeneous Enzymic Homocysteine ReagentCatch, Inc. · 2001 · Recalled
- This deviceK062808 Liquid Stable (LS) 2-Part Homocysteine ReagentCatch Incorporated · 2006
- Descendant · cites it directly · 1 of its ownK083222 Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent, Model…Axis-Shield Diagnostics, Ltd. · 2009 · Recalled
- Descendant · 2 generations on · 0 of its ownK112790 Axis-Shield 3-Reagent Homocysteine Assay for SynchronAxis-Shield Diagnostics, Ltd. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011689 | Homogeneous Enzymic Homocysteine Reagent | Catch, Inc. | 2001 | 1 |
| 0 (this device) | 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 |
| +2 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
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 |
|---|---|---|---|
| * | K011689 | Homogeneous Enzymic Homocysteine ReagentSummary page 2…Homocysteine Enzymic Comparison 2-Part Homocysteine Homocysteine Reagent Reagent K011689 Intended Use Intended for the in vitro Intended for the in vitro Same quantitative determination… | 2001 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083222 | Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent, Model FHRK100 | 2009 | 1 |
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?
- Its one ancestor has a recall.
- Of its descendants, K083222 (Axis-Shield Diagnostics, Ltd., 2009) has gone furthest, with 1 descendant 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?
Intended for the in vitro quantitative determination of total
Homocysteine in serum and plasma to assist in the diagnosis
and treatment of patients suspected in having homocystinuria and
hyperhomocysteinemia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062808 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062808: Liquid Stable (LS) 2-Part Homocysteine Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062808
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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