Cleared Traditional

DIADEXUS PLAC TEST

K050523 · Diadexus, Inc. · Chemistry

Jun 2005

Decision

105d

Days

Class 2

Risk

About This 510(k) Submission

K050523 is an FDA 510(k) clearance for the DIADEXUS PLAC TEST, a Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2 (Class II — Special Controls, product code NOE), submitted by Diadexus, Inc. (South San Francisco, US). The FDA issued a Cleared decision on June 15, 2005, 105 days after receiving the submission on March 2, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5600.

Submission Details

510(k) Number	K050523 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 02, 2005
Decision Date	June 15, 2005
Days to Decision	105 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.