510(k) · Cleared
ClearedDiadexus Plac Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diadexus, Inc. · NOE Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
Cleared on Jun 15, 2005 after a 105-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Jun 15, 2005
- Review
- 105 days
- Class
- Class II
- Product code
- NOE
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK050523 Diadexus Plac TestDiadexus, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK062234 Modification to Diadexus Plac TestDiadexus, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK101853 Plac Test Reagent Kit, Models 90107, 90112, 90115, 90116, 10-0112…Diadexus, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK072599 Plac Test Reagent Kit,Calibrator Kit, LP-PLA2 Control Kit, Model (S)…Diadexus, Inc. · 2007 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K062234Modification to Diadexus Plac TestDiadexus, Inc. · 2006 · cites it directly2descendants
- K101853Plac Test Reagent Kit, Models 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115Diadexus, Inc. · 2011 · 2 generations on0descendants
- K072599Plac Test Reagent Kit,Calibrator Kit, LP-PLA2 Control Kit, Model (S) 90107,90109,90109Diadexus, Inc. · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050523 | Diadexus Plac Test | Diadexus, Inc. | 2005 | — |
| +1 | K062234 | Modification to Diadexus Plac Test | Diadexus, Inc. | 2006 | 1 |
| +2 | K101853 | Plac Test Reagent Kit, Models 90107, 90112, 90115, 90116, 10-0112, 10-0113… | Diadexus, Inc. | 2011 | — |
| +2 | K072599 | Plac Test Reagent Kit,Calibrator Kit, LP-PLA2 Control Kit, Model (S)… | Diadexus, Inc. | 2007 | 7 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 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 NOE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062234 | Modification to Diadexus Plac Test | 2006 | 2 |
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, K062234 (Diadexus, Inc., 2006) has gone furthest, with 2 descendants of its own.
How does its category compare?
All NOE devicesNOE Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NOE
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · NOE
Too few NOE 510(k)s in any year since 2007 to give a median.
Recalls per year · NOE
2in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NOE
1in 2015
MAUDE reports naming product code NOE, 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 | — | 3 | 0 |
| 2009 | 0 | — | 7 | 0 |
| 2010 | 0 | — | 2 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The diaDexus PLACTM test is an enzyme immunoassay for the quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) in human plasma, to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk for coronary heart disease and ischemic stroke associated with atherosclerosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050523 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050523: Diadexus Plac Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050523
Report an extraction error
Are you the manufacturer?
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