510(k) · Cleared
ClearedN Latex LP (a)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
Cleared on Jan 18, 2002 as substantially equivalent to K000121 (Beckman Coulter, Inc., 2000) after a 121-day review. Its family tree reaches back 1 generation to 2000. 7 later devices descend from it.
- Decided
- Jan 18, 2002
- Review
- 121 days
- Class
- Class II
- Product code
- DFC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000121 (2000). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK000121 Immage Immunochemistry System Lipoprotein (a) Lpax Reagent, Array…Beckman Coulter, Inc. · 2000
- This deviceK013128 N Latex LP (a)Dade Behring, Inc. · 2002
- Descendant · cites it directly · 4 of its ownK030477 Diadexus Plac TestDiadexus, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 2 of its ownK050029 Cardiompo TestPrognostix, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK050487 Quantia LA (a)Biokit, S.A. · 2005
- Descendant · 2 generations on · 0 of its ownK141575 Plac Test for LP-PLA2 ActivityDiadexus, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK132400 LP (a) Calibrators, and LP (a) ControlsBiokit, S.A. · 2013
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K030477Diadexus Plac TestDiadexus, Inc. · 2003 · cites it directly4descendants
- K050029Cardiompo TestPrognostix, Inc. · 2005 · 2 generations on2descendants
- K050487Quantia LA (a)Biokit, S.A. · 2005 · cites it directly1descendant
- K141575Plac Test for LP-PLA2 ActivityDiadexus, Inc. · 2014 · 2 generations on0descendants
- K132400LP (a) Calibrators, and LP (a) ControlsBiokit, S.A. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000121 | Immage Immunochemistry System Lipoprotein (a) Lpax Reagent, Array System… | Beckman Coulter, Inc. | 2000 | — |
| 0 (this device) | K013128 | N Latex LP (a) | Dade Behring, Inc. | 2002 | — |
| +1 | K030477 | Diadexus Plac Test | Diadexus, Inc. | 2003 | 2 |
| +2 | K050029 | Cardiompo Test | Prognostix, Inc. | 2005 | — |
| +1 | K050487 | Quantia LA (a) | Biokit, S.A. | 2005 | — |
| +2 | K141575 | Plac Test for LP-PLA2 Activity | Diadexus, Inc. | 2014 | — |
| +2 | K132400 | LP (a) Calibrators, and LP (a) Controls | Biokit, S.A. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K000121 | Immage Immunochemistry System Lipoprotein (a) Lpax Reagent, Array System Lipoprotein (a)…Summary page 1…poprotein immunological test system, Class Il (866.5600) Product Code: 81 DFC 3. Identification of the Legally Marketed Device: Beckman Coulter Array® System LPA assay (K000121) 4, Device Description: Polystyrene latex particles coated with specific antibodies to human Lp(a) are agglutinated when mixed w… | 2000 |
What descends from it? (7)
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?
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?
N Latex Lp(a) Reagent is an in vitro diagnostic test for the quantitative determination of Lipoprotein(a) [Lp(a)] in human serum or plasma.
N Latex Lp(a) aids in the diagnosis of disorders of lipid (fat) metabolism and helps to identify persons at risk from cardiovascular disease in specific populations when used in conjunction with clinical evaluation.
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/K013128 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013128: N Latex LP (a).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013128
Report an extraction error
Are you the manufacturer?
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