510(k) · Cleared
ClearedLDL-EX Seiken Assay Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Denka Seiken Co., Ltd. · MRR System, Test, Low Density, Lipoprotein
Cleared on Jan 26, 2005 as substantially equivalent to K971573 (Genzyme Corp., 1997) after a 63-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Jan 26, 2005
- Review
- 63 days
- Class
- Class I
- Product code
- MRR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971573 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK971573 N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol…Genzyme Corp. · 1997
- This deviceK043264 LDL-EX Seiken Assay KitDenka Seiken Co., Ltd. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971573 | N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol Calibrator… | Genzyme Corp. | 1997 | — |
| 0 (this device) | K043264 | LDL-EX Seiken Assay Kit | Denka Seiken Co., Ltd. | 2005 | — |
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 K241800 Atellica® CH HDL Cholesterol (HDLC)& Atellica®…score 8.0 · 2 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K971573 | N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol Calibrator, Genzyme LDL…Summary page 1…ass: I Product Code: MRR (3) Legally marketed predicate device: N-Geneous LDL Cholesterol Reagent [Genzyme Corp.] (K971573) (4) Subject device description: The LDL-EX SEIKEN Assay Kit is an in vitro diagnostic test for the quantitative deter… | 1997 |
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 no recall.
- 6 other devices also cite its predicate K971573.
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.
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 LDL-EX SEIKEN Assay Kit is an in vitro diagnostic test for the quantitative determination of low-density lipoprotein cholesterol (LDL-C) in human serum and heparinized- or EDTA-plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus, atherosclerosis and various liver and renal diseases). The device is intended to be used on automated chemistry analyzers in clinical laboratories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043264: LDL-EX Seiken Assay Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043264
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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