510(k) · Cleared
Recalled · Class II · 2024Homocysteine Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche · LPS Urinary Homocystine (Nonquantitative) Test System
Cleared on Jun 5, 2012 as substantially equivalent to K061296 (Diazyme Laboratories, 2006) and 2 other predicates after a 165-day review. Its family tree reaches back 1 generation to 2004. It has been recalled 3 times.
- Decided
- Jun 5, 2012
- Review
- 165 days
- Class
- Class II
- Product code
- LPS
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 1 generation to K042448 (2004). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK042448 Diazyme Homocysteine Enzymatic Assay KitGeneral Atomics · 2004
- This deviceK113793 Homocysteine TestRoche · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042448 | Diazyme Homocysteine Enzymatic Assay Kit | General Atomics | 2004 | — |
| 0 (this device) | K113793 | Homocysteine Test | Roche | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 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? (3)
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 |
|---|---|---|---|
| * | K061296 | Diazyme Homocysteine Enzymatic Assay Kit for Cobas Integra and Homocysteine CalibratorSummary page 3…ubstantial equivalence for the Homocysteine devices Enzymatic Reagent to the currently marketed Diazyme Homocysteine Enzymatic Assay cleared in K06 1296 and K042448. Roche claims substantial equivalence for the Homocysteine Calibrator and Controls… | 2006 |
| * | K042448 | Diazyme Homocysteine Enzymatic Assay KitSummary page 3…uivalence for the Homocysteine devices Enzymatic Reagent to the currently marketed Diazyme Homocysteine Enzymatic Assay cleared in K06 1296 and K042448. Roche claims substantial equivalence for the Homocysteine Calibrator and Controls to the curr… | 2004 |
| * | K071971 | Diazyme Homocysteine 2 Reagent Enzymatic Assay Kit, and Calibrators, Model (S) Dzxxxa…Summary page 3…ivalence for the Homocysteine Calibrator and Controls to the currently marketed Diazyme Homocysteine Calibrator and Controls cleared in K071971 and K042448, respectively. Substantial The following table compares the features of the draft device with… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 17, 2024 | Class II | Z-0489-2025 | Under Investigation by firm | Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias) |
| Oct 4, 2019 | Class II | Z-0679-2020 | Device Design | Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules |
| Mar 23, 2015 | Class II | Z-1622-2015 | Nonconforming Material/Component | Customers complained about under-recovery of non-Roche controls and discrepant low patient results with certain Homocysteine reagent lots. This negative bias could, in the worst case, lead to inaccurately low Homocysteine results. An… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
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 Homocysteine Enzymatic Assay is an in vitro test far the quantitative determination of total L-homocysteine in humnan serum and plasma on Roche/Hitachi cobas c systems. The assay can assist in the diagnosis of patients suspected of having hyperhomocysteinemnia or homocystinuria.
The Homocysteine Calibrator Kit is intended for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.
The H-omocysteine Control Kit is intended for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113793 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113793: Homocysteine Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113793
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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