510(k) · Cleared
ClearedPolymedco Homocysteine Test for the Poly-Chem and Hitachi Chemistry Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polymedco, Inc. · LPS Urinary Homocystine (Nonquantitative) Test System
Cleared on Feb 4, 2004 after a 70-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 4, 2004
- Review
- 70 days
- Class
- Class II
- Product code
- LPS
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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 Polymedco Homocysteine Test is intended for the quantitative in vitro determination of total homocysteine in serum and plasma on automated clinical chemistry analyzers. This device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The Homocysteine Calibrators are a device intended for medical purposes for use with the Polymedco Homocysteine assay to establish points of reference that…
Read the full statement (126 words)
The Polymedco Homocysteine Test is intended for the quantitative in vitro determination of total homocysteine in serum and plasma on automated clinical chemistry analyzers. This device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
The Homocysteine Calibrators are a device intended for medical purposes for use with the Polymedco Homocysteine assay to establish points of reference that are used in determination of values in the measurement of homocysteine in human serum or plasma.
The Homocysteine Controls are intended for use as an assayed quality control serum to monitor the precision and accuracy of the laboratory testing procedures for total homocysteine.
Note: The parameters and labeling provided are for use on the Polymedco Poly-Chem and the Hitachi chemistry analyzer systems.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K033706 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033706: Polymedco Homocysteine Test for the Poly-Chem and Hitachi Chemistry Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033706
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)
- Page last updated Nov 3, 2026