510(k) · Cleared
ClearedAtellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · MRR System, Test, Low Density, Lipoprotein
Cleared on Jul 26, 2024 as substantially equivalent to K021316 (Genzyme Corp., 2002) and 1 other predicate after a 35-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Jul 26, 2024
- Review
- 35 days
- Class
- Class I
- Product code
- MRR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K971573 (1997). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK971573 N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol…Genzyme Corp. · 1997
- 1 generation backK020724 Dimension Automated LDL Cholesterol Flex Reagentcartridge Method…Dade Behring, Inc. · 2002
- This deviceK241800 Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol…Siemens Healthcare Diagnostics, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971573 | N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol Calibrator… | Genzyme Corp. | 1997 | — |
| −1 | K020724 | Dimension Automated LDL Cholesterol Flex Reagentcartridge Method, Model DF131 | Dade Behring, Inc. | 2002 | — |
| 0 (this device) | K241800 | Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) | Siemens Healthcare Diagnostics, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 MRR? 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 MRR device
- #1 K210801 AXINON® LDL-p Test Systemscore 6.3 · 3 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K021316 | Ultra N-Geneous HDL Cholesterol Reagent 1/REAGENT2; Ultra N-Geneous HDL Cholestreol…Summary page 4…Candidate Device Predicate Device Predicate 510(k) Clearance# Atellica® CH HDL Ultra N-geneous® HDL K021316 Cholesterol (HDLC) Cholesterol Reagent Atellica® CH LDL Cholesterol Dimension® Automated LDL… | 2002 |
| * | K020724 | Dimension Automated LDL Cholesterol Flex Reagentcartridge Method, Model DF131Summary page 4…Ultra N-geneous® HDL K021316 Cholesterol (HDLC) Cholesterol Reagent Atellica® CH LDL Cholesterol Dimension® Automated LDL K020724 (LDLC) Cholesterol (ALDL) Siemens Healthcare Diagnostics Inc.… | 2002 |
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?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 22.2 years on median.
- None of the 3 ancestors has a recall.
- 6 other devices also cite its predicate K021316.
How does its category compare?
All MRR devicesMRR System, Test, Low Density, Lipoprotein: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MRR
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MRR
Too few MRR 510(k)s in any year since 2007 to give a median.
Recalls per year · MRR
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRR
1in 2024
MAUDE reports naming product code MRR, 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 | 0 |
| 2008 | 1 | — | 2 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 1 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 1 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Atellica® CH HDL Cholesterol (HDLC) assay is for in vitro diagnostic use in the quantitative determination of HDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium Heparin) using the Atellica® CH Analyzer. HDLC measurements are used in the diagnosis and treatment of atherosclerosis.
The Atellica® CH LDL Cholesterol (LDLC) assay is for in vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium heparin) using the Atellica® CH Analyzer. LDLC measurements are used in the diagnosis and treatment of atherosclerosis
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K241800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241800: Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241800
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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