510(k) · Cleared
ClearedRaichem HDL Cholesterol Using Cantrol HDL Precipitating Tubes on the Cobas Mira Anaylzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemagen Diagnostics, Inc. · LBR Ldl & Vldl Precipitation, Hdl
Cleared on Dec 24, 2002 after a 42-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Dec 24, 2002
- Review
- 42 days
- Class
- Class I
- Product code
- LBR
- 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 LBR? 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 LBR devicesLBR Ldl & Vldl Precipitation, Hdl: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LBR
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · LBR
Too few LBR 510(k)s in any year since 2007 to give a median.
Recalls per year · LBR
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LBR
8in 2025
MAUDE reports naming product code LBR, 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 | 0 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 0 | — | 4 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 1 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Raichem Cholesterol Rapid Liquid Reagent may be used with the CANTROLa HDL Cholesterol Precipitating Reagent Tubes to separate and determine HDL cholesterol in serum or EDTA plasma on the Cobas Mira chemistry systems. High-density lipoprotein measurement in conjunction with other lipid determinations has been shown to be usefui in assessing the risk of coronary artery disease. For In Vitro Diagnostic Use Only.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K023784 · printed Nov 3, 2026
Cite this page
510(k) Report. “K023784: Raichem HDL Cholesterol Using Cantrol HDL Precipitating Tubes on the Cobas Mira Anaylzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K023784
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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