510(k) · Cleared
Recalled · 2008Diadexus 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 Jul 18, 2003 as substantially equivalent to K013128 (Dade Behring, Inc., 2002) after a 155-day review. Its family tree reaches back 2 generations to 2000. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 18, 2003
- Review
- 155 days
- Class
- Class II
- Product code
- NOE
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000121 (2000). 4 later devices descend from it, 2 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 deviceK030477 Diadexus Plac TestDiadexus, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK050029 Cardiompo TestPrognostix, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK141575 Plac Test for LP-PLA2 ActivityDiadexus, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK071474 Dimension Clinical Chemistry System Mpo Flex Reagent Cartridge…Siemens Healthcare Diagnostics · 2008
- Descendant · 2 generations on · 0 of its ownK062840 Triage Protein C Controls and Calibration Verification ControlsBiosite Incorporated · 2007
Most influential descendants
Showing 4 of 4 · See all- K050029Cardiompo TestPrognostix, Inc. · 2005 · cites it directly2descendants
- K141575Plac Test for LP-PLA2 ActivityDiadexus, Inc. · 2014 · cites it directly0descendants
- K071474Dimension Clinical Chemistry System Mpo Flex Reagent Cartridge, Calibrator,Control…Siemens Healthcare Diagnostics · 2008 · 2 generations on0descendants
- K062840Triage Protein C Controls and Calibration Verification ControlsBiosite Incorporated · 2007 · 2 generations on0descendants
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) | K030477 | Diadexus Plac Test | Diadexus, Inc. | 2003 | — |
| +1 | K050029 | Cardiompo Test | Prognostix, Inc. | 2005 | — |
| +1 | K141575 | Plac Test for LP-PLA2 Activity | Diadexus, Inc. | 2014 | — |
| +2 | K071474 | Dimension Clinical Chemistry System Mpo Flex Reagent Cartridge… | Siemens Healthcare Diagnostics | 2008 | — |
| +2 | K062840 | Triage Protein C Controls and Calibration Verification Controls | Biosite Incorporated | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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 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 |
|---|---|---|---|
| * | K013128 | N Latex LP (a) | 2002 |
What descends from it? (4)
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 |
|---|---|---|---|---|
| Jul 18, 2008 | Not classified | Z-2399-2008 | Finished device change control | Product may give Lp-PLA2 values at up to 22% lower than accurate values. |
| Jul 18, 2008 | Not classified | Z-2400-2008 | Finished device change control | Product may give Lp-PLA2 values at up to 22% lower than accurate values. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K050029 (Prognostix, Inc., 2005) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K013128.
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 PLACTMtest 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030477 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030477: Diadexus Plac Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030477
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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