510(k) · Cleared
ClearedBio-Rad Homocysteine by HPLC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · LPS Urinary Homocystine (Nonquantitative) Test System
Cleared on Dec 21, 1999 as substantially equivalent to K980907 (Axis Biochemicals, Asa, 1998) after a 95-day review. Its family tree reaches back 1 generation to 1998. 4 later devices descend from it.
- Decided
- Dec 21, 1999
- Review
- 95 days
- Class
- Class II
- Product code
- LPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980907 (1998). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK980907 Axis Homocysteine Enzyme ImmunoassayAxis Biochemicals, Asa · 1998
- This deviceK993107 Bio-Rad Homocysteine by HPLCBio-Rad · 1999
- Descendant · cites it directly · 1 of its ownK061588 Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2006 · Recalled
- Descendant · cites it directly · 1 of its ownK030754 A/C Enzymatic Homocysteine AssayAnticancer, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK123930 Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2…Ortho-Clinical Diagnostics, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK080851 A/C Portable Enzymatic Homocysteine AssayAnticancer, Inc. · 2008
Most influential descendants
Showing 4 of 4 · See all- K061588Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator Kit 27, Hcy…Ortho-Clinical Diagnostics, Inc. · 2006 · cites it directly1descendant
- K030754A/C Enzymatic Homocysteine AssayAnticancer, Inc. · 2003 · cites it directly1descendant
- K123930Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance Verifiers…Ortho-Clinical Diagnostics, Inc. · 2013 · 2 generations on0descendants
- K080851A/C Portable Enzymatic Homocysteine AssayAnticancer, Inc. · 2008 · 2 generations on0descendants
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) | K993107 | Bio-Rad Homocysteine by HPLC | Bio-Rad | 1999 | — |
| +1 | K061588 | Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator… | Ortho-Clinical Diagnostics, Inc. | 2006 | 1 |
| +1 | K030754 | A/C Enzymatic Homocysteine Assay | Anticancer, Inc. | 2003 | — |
| +2 | K123930 | Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance… | Ortho-Clinical Diagnostics, Inc. | 2013 | — |
| +2 | K080851 | A/C Portable Enzymatic Homocysteine Assay | Anticancer, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K980907 | Axis Homocysteine Enzyme ImmunoassaySummary page 1…29, 1999 Bio-Rad Homocysteine by HPLC Urinary homocysteine (non-quantitative) test system Axis® Homocysteine Enzyme Immunoassay Axis® Biochemicals, ASA Oslo, Norway K980907 The Bio-Rad Homocysteine by HPLC test is intended for the quantitative determination of total Homocysteine in human plasma or s… | 1998 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 Bio-Rad Homocysteine by HPLC test is intended for the quantitative determination of total Homocysteine in human plasma or serum.
The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia or homocysteinuria.
For in vitro diagnostic use only.
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/K993107 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993107: Bio-Rad Homocysteine by HPLC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993107
Report an extraction error
Are you the manufacturer?
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