510(k) · Cleared
ClearedQuantia LA (a)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biokit, S.A. · DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
Cleared on Apr 26, 2005 as substantially equivalent to K013128 (Dade Behring, Inc., 2002) after a 60-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Apr 26, 2005
- Review
- 60 days
- Class
- Class II
- Product code
- DFC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000121 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK000121 Immage Immunochemistry System Lipoprotein (a) Lpax Reagent, Array…Beckman Coulter, Inc. · 2000
- 1 generation backK013128 N Latex LP (a)Dade Behring, Inc. · 2002
- This deviceK050487 Quantia LA (a)Biokit, S.A. · 2005
- Descendant · cites it directly · 0 of its ownK132400 LP (a) Calibrators, and LP (a) ControlsBiokit, S.A. · 2013
Most influential descendants
Showing 1 of 1 · See all- K132400LP (a) Calibrators, and LP (a) ControlsBiokit, S.A. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000121 | Immage Immunochemistry System Lipoprotein (a) Lpax Reagent, Array System… | Beckman Coulter, Inc. | 2000 | — |
| −1 | K013128 | N Latex LP (a) | Dade Behring, Inc. | 2002 | — |
| 0 (this device) | K050487 | Quantia LA (a) | Biokit, S.A. | 2005 | — |
| +1 | K132400 | LP (a) Calibrators, and LP (a) Controls | Biokit, S.A. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K013128 | N Latex LP (a)Summary page 1…nsity lipoprotein immunological test system Class II DFC lipoprotein, low-density, antigen, antiserum, control Identification of predicate device(s): K01 3128 N-latex Lp(a) (Dade Behring) Description of the device/intended use(s): The Quantia Lp(a) is intended as a latex particle e… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132400 | LP (a) Calibrators, and LP (a) Controls | 2013 | 0 |
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 5 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K132400 (Biokit, S.A., 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K013128.
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 Quantia Lp(a) is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum or plasma (EDTA, heparin, citrate) on Clinical Chemistry Systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations, when used in conjunction with clinical evaluation.…
Read the full statement (101 words)
The Quantia Lp(a) is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum or plasma (EDTA, heparin, citrate) on Clinical Chemistry Systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations, when used in conjunction with clinical evaluation.
Quantia Lp(a) Control is intended for use in monitoring the quality control of results obtained with the Quantia Lp(a) reagents by turbidimetry.
Quantia Lp(a) standard is intended for use in establishing the calibration curve for the Quantia Lp(a) reagents by turbidimetry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050487 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050487: Quantia LA (a).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050487
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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