Cleared Traditional

PLAC TEST FOR LP-PLA2 ACTIVITY

K141575 · Diadexus, Inc. · Chemistry

Dec 2014

Decision

186d

Days

Class 2

Risk

About This 510(k) Submission

K141575 is an FDA 510(k) clearance for the PLAC TEST FOR LP-PLA2 ACTIVITY, a Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2 (Class II — Special Controls, product code NOE), submitted by Diadexus, Inc. (Redwood Shores, US). The FDA issued a Cleared decision on December 15, 2014, 186 days after receiving the submission on June 12, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5600.

Submission Details

510(k) Number	K141575 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 12, 2014
Decision Date	December 15, 2014
Days to Decision	186 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	NOE — Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5600
Definition	The Lipoprotein-associated Phospholipase A2, Immunoassay, System, Test, Is Intended To Measure Lipoprotein-associated Phospholipase A2 In Human Plasma In Conjunction With Clinical Evaluation And Other Patient Risk Factors Including Biochemical Analyses As An Aid In Predicting Risk For Coronary Heat Disease. This Device Differs From The Classification Regulation In That It Is A Different Analyte, Thus A New Marker For Predicting Risk Of Coronary Heart Disease. This Device Is Measuring An Enzyme That Is Produced By Macrophages Where As The Regulation Is For The Measurement Of A Lipoprotein.