510(k) · Cleared
Recalled · 2010Modification to Diadexus 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 Sep 11, 2006 as substantially equivalent to K050523 (Diadexus, Inc., 2005) after a 40-day review. Its family tree reaches back 1 generation to 2005. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 11, 2006
- Review
- 40 days
- Class
- Class II
- Product code
- NOE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K050523 (2005). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK050523 Diadexus Plac TestDiadexus, Inc. · 2005
- This deviceK062234 Modification to Diadexus Plac TestDiadexus, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK101853 Plac Test Reagent Kit, Models 90107, 90112, 90115, 90116, 10-0112…Diadexus, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK072599 Plac Test Reagent Kit,Calibrator Kit, LP-PLA2 Control Kit, Model (S)…Diadexus, Inc. · 2007 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K050523 | Diadexus Plac Test | Diadexus, Inc. | 2005 | — |
| 0 (this device) | K062234 | Modification to Diadexus Plac Test | Diadexus, Inc. | 2006 | — |
| +1 | K101853 | Plac Test Reagent Kit, Models 90107, 90112, 90115, 90116, 10-0112, 10-0113… | Diadexus, Inc. | 2011 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K050523 | Diadexus Plac TestSummary page 3…cteristics - Clinical No new clinical data was generated. The modified PLAC test has the same performance characteristics and clinical utility as the cleared PLAC test (k050523). Page 3 of 3 DEPARTMENT OF H… | 2005 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 20, 2010 | Not classified | Z-1737-2011 | Nonconforming Material/Component | Product fails stability tests prior to expiration date. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K101853 (Diadexus, Inc., 2011) has gone furthest, with 0 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 PLAC® test is an enzyme immunoassay for the quantitative determination of Lp-PLA 2 (lipoprotein-associated phospholipase A 2) in human plasma and serum, 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/K062234 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062234: Modification to Diadexus Plac Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062234
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