Cleared Traditional

PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115

K101853 · Diadexus, Inc. · Chemistry

Jan 2011

Decision

186d

Days

Class 2

Risk

About This 510(k) Submission

K101853 is an FDA 510(k) clearance for the PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115, 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 January 3, 2011, 186 days after receiving the submission on July 1, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5600.

Submission Details

510(k) Number	K101853 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 2010
Decision Date	January 03, 2011
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.