510(k) · Cleared
ClearedA/C Enzymatic Homocysteine Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anticancer, Inc. · LPS Urinary Homocystine (Nonquantitative) Test System
Cleared on Jul 11, 2003 as substantially equivalent to K993107 (Bio-Rad, 1999) after a 123-day review. Its family tree reaches back 2 generations to 1998. 1 later device descends from it.
- Decided
- Jul 11, 2003
- Review
- 123 days
- Class
- Class II
- Product code
- LPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K980907 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK980907 Axis Homocysteine Enzyme ImmunoassayAxis Biochemicals, Asa · 1998
- 1 generation backK993107 Bio-Rad Homocysteine by HPLCBio-Rad · 1999
- This deviceK030754 A/C Enzymatic Homocysteine AssayAnticancer, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK080851 A/C Portable Enzymatic Homocysteine AssayAnticancer, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K080851A/C Portable Enzymatic Homocysteine AssayAnticancer, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980907 | Axis Homocysteine Enzyme Immunoassay | Axis Biochemicals, Asa | 1998 | — |
| −1 | K993107 | Bio-Rad Homocysteine by HPLC | Bio-Rad | 1999 | — |
| 0 (this device) | K030754 | A/C Enzymatic Homocysteine Assay | Anticancer, Inc. | 2003 | — |
| +1 | K080851 | A/C Portable Enzymatic Homocysteine Assay | Anticancer, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 |
|---|---|---|---|
| * | K993107 | Bio-Rad Homocysteine by HPLCSummary page 1…ostics Group 4000 Alfred Nobel Drive Hercules, California 94547 5 1O(k) Number: K993 107 Tan YrnA.51O w 5 1Ok Summary 2 2/20/03 A/C Enzvrnatic Homo… | 1999 |
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 |
|---|---|---|---|
| K080851 | A/C Portable Enzymatic Homocysteine Assay | 2008 | 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?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K080851 (Anticancer, Inc., 2008) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K993107.
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 A/C Enzymatic Homocysteine Assay is intended for the quantitative determination of total homocysteine (tHCY) in human plasma or serum.
The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia.
The A/C Enzymatic Homocysteine Assay is only for in vitro diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030754 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030754: A/C Enzymatic Homocysteine Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030754
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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