510(k) · Cleared
Recalled · 2009Plac Test Reagent Kit,Calibrator Kit, LP-PLA2 Control Kit, Model (S) 90107,90109,90109
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 Dec 20, 2007 as substantially equivalent to K062234 (Diadexus, Inc., 2006) after a 97-day review. Its family tree reaches back 2 generations to 2005. It has been recalled 7 times.
- Decided
- Dec 20, 2007
- Review
- 97 days
- Class
- Class II
- Product code
- NOE
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 2 generations to K050523 (2005). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K062234 | Modification to Diadexus Plac TestSummary page 2…CFR 866.5600, Product Code DFC) 1 LegaIljz Marketed Device to which Equivalency is Claimed PLAC' Test (k062234) Description of Device The diaDexus PLAC® Test assay consists of separately packaged reagents, calibrators and controls for the… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 29, 2009 | Not classified | Z-1749-2010 | Other | Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifestyle changes or intensified pharmaceutical therapy; such as… |
| Oct 29, 2009 | Not classified | Z-1752-2010 | Other | Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifestyle changes or intensified pharmaceutical therapy; such as… |
| Oct 29, 2009 | Not classified | Z-1753-2010 | Other | Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifestyle changes or intensified pharmaceutical therapy; such as… |
| Oct 29, 2009 | Not classified | Z-1750-2010 | Other | Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifestyle changes or intensified pharmaceutical therapy; such as… |
| Oct 29, 2009 | Not classified | Z-1748-2010 | Other | Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifestyle changes or intensified pharmaceutical therapy; such as… |
| Oct 29, 2009 | Not classified | Z-1751-2010 | Other | Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifestyle changes or intensified pharmaceutical therapy; such as… |
| Feb 9, 2009 | Not classified | Z-1205-2009 | Process control | Premature Expiration-- the product is projected to fall short of expected shelf life, and may result in inaccurate results. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 1.3 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K062234.
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. 2007, this device’s year, is highlighted.
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 PLAC® Test Reagent Kit is a turbidimetric immunoassay for the quantitative determination of Lp-PLA 2 (lipoprotein-associated phospholipase A 2) in human plasma or serum on automated clinical chemistry analyzers, 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. The PLAC® Test Calibrator Kit is intended to…
Read the full statement (128 words)
The PLAC® Test Reagent Kit is a turbidimetric immunoassay for the quantitative determination of Lp-PLA 2 (lipoprotein-associated phospholipase A 2) in human plasma or serum on automated clinical chemistry analyzers, 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.
The PLAC® Test Calibrator Kit is intended to establish points of reference that are used in the determination of values in the measurement of Lp-PLA 2 by the PLAC® Test Reagent Kit.
The Lp-PLA 2 Control Kit is intended for use as a quality control tool to monitor the performance within the clinical range of the PLAC® Test Reagent Kit, a turbidimetric immunoassay for the quantitative determination of Lp-PLA 2.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072599 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072599: Plac Test Reagent Kit,Calibrator Kit, LP-PLA2 Control Kit, Model (S) 90107,90109,90109.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072599
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