510(k) · Cleared
Recalled · 2004K-Assay LP (a) Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kamiya Biomedical Co. · DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
Cleared on Dec 13, 2002 after a 24-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Dec 13, 2002
- Review
- 24 days
- Class
- Class II
- Product code
- DFC
- Recalls
- 1
- 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 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?
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 29, 2004 | Not classified | Z-0940-04 | Other | Assay result not consistent with the assigned control value |
No ancestor or descendant has a Class I recall.
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 K-ASSAY Lp(a) Control Set is intended for use as an assayed quality control material for monitoring the performance of Lp(a) immunoturbidimetric assays.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K023853 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023853: K-Assay LP (a) Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023853
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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