510(k) · Cleared
ClearedHomocysteine Microtiter Plate Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diazyme Laboratories · LPS Urinary Homocystine (Nonquantitative) Test System
Cleared on Sep 3, 2003 as substantially equivalent to K980907 (Axis Biochemicals, Asa, 1998) after a 65-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Sep 3, 2003
- Review
- 65 days
- Class
- Class II
- Product code
- LPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980907 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK980907 Axis Homocysteine Enzyme ImmunoassayAxis Biochemicals, Asa · 1998
- This deviceK032012 Homocysteine Microtiter Plate AssayDiazyme Laboratories · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980907 | Axis Homocysteine Enzyme Immunoassay | Axis Biochemicals, Asa | 1998 | — |
| 0 (this device) | K032012 | Homocysteine Microtiter Plate Assay | Diazyme Laboratories | 2003 | — |
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 |
|---|---|---|---|
| * | K980907 | Axis Homocysteine Enzyme ImmunoassaySummary page 1…marketed device to which we are claiming equivalence [807.92(a)(3)]: Axis Homocysteine EIA, manufactured by Axis Biochemicals, AS. The clearance number is K980907. Description of the device: Homocysteine Microplate HPB Assay is an EIA-like assay for the determination of tHcy… | 1998 |
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 no recall.
- 2 other devices also cite its predicate K980907.
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?
The Homocysteine Microtiter Plate Assay is intended for the quantitative determination of total L-homocysteine in human serum or plasma.
The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032012: Homocysteine Microtiter Plate Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032012
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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