Cleared Special

Diazyme PLAC? Test for Lp-PLA2 Activity

K203136 · Diazyme Laboratories, Inc. · Chemistry

Aug 2021

Decision

290d

Days

Class 2

Risk

About This 510(k) Submission

K203136 is an FDA 510(k) clearance for the Diazyme PLAC? Test for Lp-PLA2 Activity, a Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2 (Class II — Special Controls, product code NOE), submitted by Diazyme Laboratories, Inc. (Poway, US). The FDA issued a Cleared decision on August 6, 2021, 290 days after receiving the submission on October 20, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5600.

Submission Details

510(k) Number	K203136 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 20, 2020
Decision Date	August 06, 2021
Days to Decision	290 days
Submission Type	Special
Review Panel	Chemistry (CH)
Summary	Statement

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.