510(k) · Cleared

Cleared

Plac Test Reagent Kit, Models 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115

K101853510(k) TraditionalCleared Jan 3, 2011186-day reviewClass II21 CFR 866.5600

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Diadexus, Inc. · NOE Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2

Cleared on Jan 3, 2011 as substantially equivalent to K062234 (Diadexus, Inc., 2006) after a 186-day review. Its family tree reaches back 2 generations to 2005.

Decided: Jan 3, 2011
Review: 186 days
Class: Class II
Product code: NOE
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K050523 (2005). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK050523 Diadexus Plac TestDiadexus, Inc. · 2005
1 generation backK062234 Modification to Diadexus Plac TestDiadexus, Inc. · 2006 · Recalled
This deviceK101853 Plac Test Reagent Kit, Models 90107, 90112, 90115, 90116, 10-0112…Diadexus, Inc. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K050523	Diadexus Plac Test	Diadexus, Inc.	2005	—
−1	K062234	Modification to Diadexus Plac Test	Diadexus, Inc.	2006	1
0 (this device)	K101853	Plac Test Reagent Kit, Models 90107, 90112, 90115, 90116, 10-0112, 10-0113…	Diadexus, Inc.	2011	—

FIG. 1 — Lineage of K101853, 2005–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K062234	Modification to Diadexus Plac Test Summary page 1 …ocket ______ PLACO'Test ELISA Kit jdiaDexus K062234 6.0 Device Description The PLAC® Test Reagent Kit consists of separately packaged reagents, calibrators and controls for the…	Diadexus, Inc.	2006	1

Also cleared against K062234: 1 other device →

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 6 years and passes through 1 company; a new generation was cleared every 4.3 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 devices

NOE Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · NOE

1in 2021

2007high 1 (2007) · low 0 (2008)2026

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

2007high 7 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NOE

1in 2015

2007high 1 (2015) · low 0 (2007)2025

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-PLA2 (lipoprotein-associated phospholipase A2) in human serum or plasma 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 ischemnic stroke associated with atherosclerosis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101853 · printed Nov 4, 2026

Cite this page

510(k) Report. “K101853: Plac Test Reagent Kit, Models 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101853

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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