510(k) · Cleared
ClearedImmage Immunochemistry System Lipoprotein (a) Lpax Reagent, Array System Lipoprotein (a) Lpa Reagent, Lipoprotein (a) Calib
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
Cleared on May 17, 2000 after a 120-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- May 17, 2000
- Review
- 120 days
- Class
- Class II
- Product code
- DFC
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK000121 Immage Immunochemistry System Lipoprotein (a) Lpax Reagent, Array…Beckman Coulter, Inc. · 2000
- Descendant · cites it directly · 7 of its ownK013128 N Latex LP (a)Dade Behring, Inc. · 2002
- Descendant · 2 generations on · 4 of its ownK030477 Diadexus Plac TestDiadexus, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 2 of its ownK050029 Cardiompo TestPrognostix, Inc. · 2005
- Descendant · 2 generations on · 1 of its ownK050487 Quantia LA (a)Biokit, S.A. · 2005
- Descendant · 3 generations on · 0 of its ownK141575 Plac Test for LP-PLA2 ActivityDiadexus, Inc. · 2014
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K013128N Latex LP (a)Dade Behring, Inc. · 2002 · cites it directly7descendants
- K030477Diadexus Plac TestDiadexus, Inc. · 2003 · 2 generations on4descendants
- K050029Cardiompo TestPrognostix, Inc. · 2005 · 3 generations on2descendants
- K050487Quantia LA (a)Biokit, S.A. · 2005 · 2 generations on1descendant
- K141575Plac Test for LP-PLA2 ActivityDiadexus, Inc. · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000121 | Immage Immunochemistry System Lipoprotein (a) Lpax Reagent, Array System… | Beckman Coulter, Inc. | 2000 | — |
| +1 | K013128 | N Latex LP (a) | Dade Behring, Inc. | 2002 | — |
| +2 | K030477 | Diadexus Plac Test | Diadexus, Inc. | 2003 | 2 |
| +3 | K050029 | Cardiompo Test | Prognostix, Inc. | 2005 | — |
| +2 | K050487 | Quantia LA (a) | Biokit, S.A. | 2005 | — |
| +3 | K141575 | Plac Test for LP-PLA2 Activity | Diadexus, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 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), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
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?
- Of its descendants, K013128 (Dade Behring, Inc., 2002) has gone furthest, with 7 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 | — |
https://510kreport.com/device/K000121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000121: Immage Immunochemistry System Lipoprotein (a) Lpax Reagent, Array System Lipoprotein (a) Lpa Reagent, Lipoprotein (a) Calib.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000121
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026