510(k) · Cleared
ClearedAdvia Chemistry Lipoprotein (a) Reagent Advia Chemistry Lipoprotein (a) Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
Cleared on Dec 20, 2012 as substantially equivalent to K011568 (Randox Laboratories, Ltd., 2001) after an 83-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Dec 20, 2012
- Review
- 83 days
- Class
- Class II
- Product code
- DFC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011568 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK011568 Randox LipoproteinRandox Laboratories, Ltd. · 2001 · Recalled
- This deviceK123046 Advia Chemistry Lipoprotein (a) Reagent Advia Chemistry Lipoprotein…Siemens Healthcare Diagnostics, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011568 | Randox Lipoprotein | Randox Laboratories, Ltd. | 2001 | 2 |
| 0 (this device) | K123046 | Advia Chemistry Lipoprotein (a) Reagent Advia Chemistry Lipoprotein (a)… | Siemens Healthcare Diagnostics, Inc. | 2012 | — |
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 |
|---|---|---|---|
| * | K011568 | Randox LipoproteinSummary page 2…Clinical Chemistry F. Predicate Device: Reagent 1. Device Name: Randox Lipoprotein (a) assay 2. Common Name: Randox Lipoprotein (a) assay 3. 510(k) Number k01 1568 4. Manufacturer: Randox Laboratories, Ltd. Uk. Calibrator 1. Device Name: Randox Lipoprotein(a) Calibrator Series 2. Commo… | 2001 |
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 a 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. 2012, this device’s year, is highlighted.
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?
For in vitro diagnostic use in th 'e quantitative measurement of lipoprotein(a)
(Lp(a)) in human serum or plasma on the ADVIA Chemistry systems.
Measurement of Lp(a) may aid in the diagnosis of disorders of lipid (fat)
metabolism and assessing persons at risk for cardiovascular diseases when used in
conjunction with clinical evaluation and other lipoprotein tests.
The ADVIA® Chemistry Lipoprotein(a) calibrators is intended for use in the
calibration of AD VIA® Chemistry systems for the AD VIA Chemistry
Lipoprotein(a) (LPA) assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123046 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123046: Advia Chemistry Lipoprotein (a) Reagent Advia Chemistry Lipoprotein (a) Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123046
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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