510(k) · Cleared
Recalled · Class II · 2019Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent, Model FHRK100
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 Jul 31, 2009 as substantially equivalent to K062808 (Catch Incorporated, 2006) after a 270-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it. It has been recalled 5 times.
- Decided
- Jul 31, 2009
- Review
- 270 days
- Class
- Class II
- Product code
- LPS
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011689 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK011689 Homogeneous Enzymic Homocysteine ReagentCatch, Inc. · 2001 · Recalled
- 1 generation backK062808 Liquid Stable (LS) 2-Part Homocysteine ReagentCatch Incorporated · 2006
- This deviceK083222 Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent, Model…Axis-Shield Diagnostics, Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK112790 Axis-Shield 3-Reagent Homocysteine Assay for SynchronAxis-Shield Diagnostics, Ltd. · 2012
Most influential descendants
Showing 1 of 1 · See all- K112790Axis-Shield 3-Reagent Homocysteine Assay for SynchronAxis-Shield Diagnostics, Ltd. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011689 | Homogeneous Enzymic Homocysteine Reagent | Catch, Inc. | 2001 | 1 |
| −1 | K062808 | Liquid Stable (LS) 2-Part Homocysteine Reagent | Catch Incorporated | 2006 | — |
| 0 (this device) | K083222 | Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent, Model FHRK100 | Axis-Shield Diagnostics, Ltd. | 2009 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K062808 | Liquid Stable (LS) 2-Part Homocysteine ReagentSummary page 1…Panel: Clinical Chemistry Product Code: LPS Legally marketed device to which equivalency is claimed: CATCH Incorporated, Liquid Stable (LS) 2-Part Homocysteine Reagent, k062808. Intended Use of Device: The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112790 | Axis-Shield 3-Reagent Homocysteine Assay for Synchron | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 16, 2019 | Class II | Z-0742-2020 | Under Investigation by firm | There is a potential performance issue as detected by an under-recovery of sample results during routine testing. |
| Sep 16, 2019 | Class II | Z-0743-2020 | Under Investigation by firm | There is a potential performance issue as detected by an under-recovery of sample results during routine testing. |
| Sep 16, 2019 | Class II | Z-0744-2020 | Under Investigation by firm | There is a potential performance issue as detected by an under-recovery of sample results during routine testing. |
| Apr 3, 2015 | Class II | Z-2063-2016 | Unknown/Undetermined by firm | Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery. The manufacturer has indicated that the HOMOCYSTEINE REAGENT lot listed above shows deterioration in assay performance… |
| Mar 20, 2015 | Class II | Z-1946-2015 | Under Investigation by firm | Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K112790 (Axis-Shield Diagnostics, Ltd., 2012) has gone furthest, with 0 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. 2009, 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 Liquid Stable (LS) 2-Part Homocysteine Reagent 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 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/K083222 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083222: Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent, Model FHRK100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083222
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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