510(k) · Cleared
ClearedLP (a)-Latex Seiken Assay Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Denka Seiken'S · DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
Cleared on Mar 8, 2002 as substantially equivalent to K982708 (DiaSorin, Inc., 1999) after a 149-day review. Its family tree reaches back 1 generation to 1999. 4 later devices descend from it.
- Decided
- Mar 8, 2002
- Review
- 149 days
- Class
- Class II
- Product code
- DFC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K982708 (1999). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK982708 SPQ Test SystemDiaSorin, Inc. · 1999 · Recalled
- This deviceK013359 LP (a)-Latex Seiken Assay KitDenka Seiken'S · 2002
- Descendant · cites it directly · 3 of its ownK082488 Diazyme LP (a) AssayGeneral Atomics · 2009
- Descendant · cites it directly · 1 of its ownK122722 Cobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190…Roche Diagnostics · 2012
- Descendant · 2 generations on · 0 of its ownK241220 Tina-quant Lipoprotein (a) Gen.2 MolarityRoche Diagnostics Operations · 2025
- Descendant · 2 generations on · 0 of its ownK131556 Diazyme Lipoprotein (a) Calibrator Set, Control SetDiazyme Laboratories · 2013
Most influential descendants
Showing 4 of 4 · See all- K082488Diazyme LP (a) AssayGeneral Atomics · 2009 · cites it directly3descendants
- K122722Cobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190; Preciset LP (a) Gen 2…Roche Diagnostics · 2012 · cites it directly1descendant
- K241220Tina-quant Lipoprotein (a) Gen.2 MolarityRoche Diagnostics Operations · 2025 · 2 generations on0descendants
- K131556Diazyme Lipoprotein (a) Calibrator Set, Control SetDiazyme Laboratories · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K982708 | SPQ Test System | DiaSorin, Inc. | 1999 | 1 |
| 0 (this device) | K013359 | LP (a)-Latex Seiken Assay Kit | Denka Seiken'S | 2002 | — |
| +1 | K082488 | Diazyme LP (a) Assay | General Atomics | 2009 | — |
| +1 | K122722 | Cobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190; Preciset LP… | Roche Diagnostics | 2012 | — |
| +2 | K241220 | Tina-quant Lipoprotein (a) Gen.2 Molarity | Roche Diagnostics Operations | 2025 | — |
| +2 | K131556 | Diazyme Lipoprotein (a) Calibrator Set, Control Set | Diazyme Laboratories | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2025 | 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 DFC? 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 DFC device
- #1 K253069 Lipoprotein (a) Molarity Assayscore 11.5 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K982708 | SPQ Test SystemSummary page 1…protein Immunological test system Panel: Immunology ' Class: 11 (3) Legally marketed predicate device(s): SPQ Test System Antibody Reagent Set for Lp(a) [DiaSorin Inc.](K982708) (4) Subject device description: The Lp(a)-Latex SEIKEN Assay Kit is a latex in vitro diagnostic immunoassay for the quantitati… | 1999 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 a recall.
- Of its descendants, K082488 (General Atomics, 2009) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DFC devicesDFC Lipoprotein, Low-Density, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DFC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DFC
Too few DFC 510(k)s in any year since 2007 to give a median.
Recalls per year · DFC
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DFC
7in 2025
MAUDE reports naming product code DFC, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 2 | 16 |
| 2025 | 1 | — | 0 | 7 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Lp(a)-Latex SEIKEN Assay kit is an in vitro diagnostic test for the quantitative determination of lipoprotein (a) [Lp(a)] in human serum and plasma samples with Hitachi 917 analyzer.
The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests.
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/K013359 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013359: LP (a)-Latex Seiken Assay Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013359
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026