510(k) · Cleared
ClearedDiazyme Homocysteine Enzymatic Assay Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Atomics · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Oct 29, 2004 after a 50-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Oct 29, 2004
- Review
- 50 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK042448 Diazyme Homocysteine Enzymatic Assay KitGeneral Atomics · 2004
- Descendant · cites it directly · 0 of its ownK113793 Homocysteine TestRoche · 2012 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K113793Homocysteine TestRoche · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042448 | Diazyme Homocysteine Enzymatic Assay Kit | General Atomics | 2004 | — |
| +1 | K113793 | Homocysteine Test | Roche | 2012 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 JJX? 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113793 | Homocysteine Test | 2012 | 0 |
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?
- Of its descendants, K113793 (Roche, 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, 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 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Diazyme Enzymatic Homocysteine Assay is intended for the in vitro quantitative determination of total L-homocysteine in serum and heparin plasma. The reagents can assist in diagnosis and treatment of patients suspected in having hyperhomocysteinemia and homocystinuria. Diazyme Homocysteine Enzymatic Assay Kit contains a single calibrator. The calibrator is used to generate a calibration point that will be used in the calculation of homocysteine…
Read the full statement (101 words)
Diazyme Enzymatic Homocysteine Assay is intended for the in vitro quantitative determination of total L-homocysteine in serum and heparin plasma. The reagents can assist in diagnosis and treatment of patients suspected in having hyperhomocysteinemia and homocystinuria.
Diazyme Homocysteine Enzymatic Assay Kit contains a single calibrator. The calibrator is used to generate a calibration point that will be used in the calculation of homocysteine concentrations in unknown serum samples.
Diazyme Homocysteine Enzymatic Assay has controls for normal serum homocysteine level and abnormal serum homocysteine level. The controls are used as reference samples for checking the functionality of the Diazyme Homocysteine Enzymatic Assay.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042448 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042448: Diazyme Homocysteine Enzymatic Assay Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042448
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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