510(k) · Cleared
ClearedSpotchem HDL, Total Cholesterol and Triglyceride Reagent Tests and Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arkray, Inc. · CHH Enzymatic Esterase--Oxidase, Cholesterol
Cleared on Nov 24, 2004 after a 76-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Nov 24, 2004
- Review
- 76 days
- Class
- Class I
- Product code
- CHH
- 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 CHH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CHH device
- #1 K251091 Lipidsscore 10.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 CHH devicesCHH Enzymatic Esterase--Oxidase, Cholesterol: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CHH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CHH
198in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHH
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHH
14in 2025
MAUDE reports naming product code CHH, 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 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 3 | 0 |
| 2010 | 0 | — | 2 | 10 |
| 2011 | 1 | — | 0 | 18 |
| 2012 | 4 | 198 | 0 | 11 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 1 | — | 1 | 1 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 2 | 5 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 2 | 2 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 1 | — | 0 | 14 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The SpotChem EZ Total Cholesterol, HDL and Triglyceride test and panel system are an in vitro diagnostic procedures intended to measure Total Cholesterol/HDLfTriglyceride quantitatively in human serum and plasma on the SpotChem EZ analyzer.
Total Cholesterol measurements are used the diagnosis and treatment of lipid and lipoprotein metabolism disorders.
HDL-Cholesterol measurements are used the diagnosis and treatment of lipid and lipoprotein metabolism disorders.
Triglyceride measurements are used in the used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042443 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042443: Spotchem HDL, Total Cholesterol and Triglyceride Reagent Tests and Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042443
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026