510(k) · Cleared
ClearedArchitect Homocysteine Reagents, Calibrators and Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axis-Shield Diagnostics, Ltd. · LPS Urinary Homocystine (Nonquantitative) Test System
Cleared on Apr 24, 2008 as substantially equivalent to K992858 (Abbott Laboratories, 1999) after a 120-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Apr 24, 2008
- Review
- 120 days
- Class
- Class II
- Product code
- LPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992858 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK992858 Abbott Axsym HomocysteineAbbott Laboratories · 1999 · Recalled
- This deviceK073640 Architect Homocysteine Reagents, Calibrators and ControlsAxis-Shield Diagnostics, Ltd. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992858 | Abbott Axsym Homocysteine | Abbott Laboratories | 1999 | 1 |
| 0 (this device) | K073640 | Architect Homocysteine Reagents, Calibrators and Controls | Axis-Shield Diagnostics, Ltd. | 2008 | — |
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 |
|---|---|---|---|
| * | K992858 | Abbott Axsym HomocysteineSummary page 1…ice Classification: Class I Classification Panel: Clinical Chemistry Product Code: JJX Legally marketed device to which equivalency is claimed: AxSYM Homocysteine Assay; K992858. Intended Use of Device: The ARCHITECT Homocysteine assay is a chemiluminescent microparticle immunoassay (CMIA)… | 1999 |
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 a recall.
- 4 other devices also cite its predicate K992858.
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. 2008, 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 ARCHITECT Homocysteine assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total L-homocysteine in human serum or plasma on the ARCHITECT i System. Homocysteine values can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The ARCHITECT Homocysteine Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative…
Read the full statement (112 words)
The ARCHITECT Homocysteine assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total L-homocysteine in human serum or plasma on the ARCHITECT i System. Homocysteine values can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
The ARCHITECT Homocysteine Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of total L-homocysteine in human serum or plasma.
The ARCHITECT Homocysteine Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System (reagents, calibrators and instrument), when used for the quantitative determination of total L-homocysteine in human serum or plasma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073640 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073640: Architect Homocysteine Reagents, Calibrators and Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073640
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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