Cleared Traditional

Diazyme 1,5-AG Assay

K180209 · Diazyme Laboratories, Inc. · Chemistry

Oct 2018

Decision

253d

Days

Class 2

Risk

About This 510(k) Submission

K180209 is an FDA 510(k) clearance for the Diazyme 1,5-AG Assay, a Assay, 1,5-anhydroglucitol (15ag) (Class II — Special Controls, product code NOZ), submitted by Diazyme Laboratories, Inc. (Poway, US). The FDA issued a Cleared decision on October 4, 2018, 253 days after receiving the submission on January 24, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number	K180209 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 24, 2018
Decision Date	October 04, 2018
Days to Decision	253 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	NOZ — Assay, 1,5-anhydroglucitol (15ag)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 864.7470
Definition	The Test Provides Quantitative Measurement Of 1,5-anhydroglucitol (15ag) In Patient's Blood. The Test Is For Professional Use, And Is Indicated For The Monitoring Of Glycemic Control In People With Diabetes.