510(k) · Cleared
ClearedHemosil Homocysteine and Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · LPS Urinary Homocystine (Nonquantitative) Test System
Cleared on Sep 22, 2006 as substantially equivalent to K992858 (Abbott Laboratories, 1999) after a 106-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Sep 22, 2006
- Review
- 106 days
- Class
- Class II
- Product code
- LPS
- Recalls
- None
- 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 deviceK061598 Hemosil Homocysteine and ControlsInstrumentation Laboratory CO · 2006
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) | K061598 | Hemosil Homocysteine and Controls | Instrumentation Laboratory CO | 2006 | — |
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…tive) test system LPS Class II 862.1660 Single (specified) analyte controls (assayed and unassayed) JJX Class I Identification of Predicate Device: K992858 Abbott IMx Homocysteine Device Intended Use and Description: HemoslL Homocysteine is an automated latex enhanced immunoass… | 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)
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.
- 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?
HemosIL Homocysteine is an automated latex enhanced immunoassay for the quantitative determination of total L-homocysteine in human citrated plasma on IL Coagulation Systems.
Homocysteine (Hey) values can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia or homocystinuria.
HemoslL Homocysteine Controls are assayed quality controls intended to monitor the accuracy and precision of HemoslL Homocysteine on IL Coagulation Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061598 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061598: Hemosil Homocysteine and Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061598
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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