510(k) · Cleared
ClearedPlac Test for LP-PLA2 Activity
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 15, 2014 as substantially equivalent to K030477 (Diadexus, Inc., 2003) after a 186-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Dec 15, 2014
- Review
- 186 days
- Class
- Class II
- Product code
- NOE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K000121 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK000121 Immage Immunochemistry System Lipoprotein (a) Lpax Reagent, Array…Beckman Coulter, Inc. · 2000
- 2 generations backK013128 N Latex LP (a)Dade Behring, Inc. · 2002
- 1 generation backK030477 Diadexus Plac TestDiadexus, Inc. · 2003 · Recalled
- This deviceK141575 Plac Test for LP-PLA2 ActivityDiadexus, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000121 | Immage Immunochemistry System Lipoprotein (a) Lpax Reagent, Array System… | Beckman Coulter, Inc. | 2000 | — |
| −2 | K013128 | N Latex LP (a) | Dade Behring, Inc. | 2002 | — |
| −1 | K030477 | Diadexus Plac Test | Diadexus, Inc. | 2003 | 2 |
| 0 (this device) | K141575 | Plac Test for LP-PLA2 Activity | Diadexus, Inc. | 2014 | — |
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 |
|---|---|---|---|
| * | K030477 | Diadexus Plac TestSummary page 5…aterial 862.1660 JJX Test Controls (assayed and unassayed) 5. Predicate Devices: K030477 - PLAC® Test 6. Device Description: The PLAC® Test for Lp-PLA2 Activity consists of the reagents, Lp-PLA2 Activity Test… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K030477.
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. 2014, 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 for Lp-PLA2 Activity is an enzyme assay for the in vitro quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) activity in EDTA-plasma and serum on automated clinical chemistry analyzers. Lp-PLA2 activity is to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk of coronary heart disease (CHD) in patients with no prior history of cardiovascular events. The…
Read the full statement (138 words)
The PLAC® Test for Lp-PLA2 Activity is an enzyme assay for the in vitro quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) activity in EDTA-plasma and serum on automated clinical chemistry analyzers. Lp-PLA2 activity is to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk of coronary heart disease (CHD) in patients with no prior history of cardiovascular events.
The Lp-PLA2 Activity Test Calibrators are intended to establish points of reference that are used in the determination of values in the measurement of Lp-PLA2 activity by the PLAC® Test for Lp-PLA2 Activity.
The Lp-PLA2 Activity Test Controls are intended for use as a quality control tool to monitor the performance within the clinical range of the PLAC® Test for Lp-PLA2 Activity, an enzyme assay for the quantitative determination of Lp-PLA2 activity
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141575 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141575: Plac Test for LP-PLA2 Activity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141575
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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