Cleared Dual Track

Assure Titanium Blood Glucose Monitoring System

K200788 · Arkray, Inc. · Chemistry

May 2022

Decision

788d

Days

Class 2

Risk

About This 510(k) Submission

K200788 is an FDA 510(k) clearance for the Assure Titanium Blood Glucose Monitoring System, a Prescription Use Blood Glucose Meter For Near-patient Testing (Class II — Special Controls, product code PZI), submitted by Arkray, Inc. (Kamigyo-Ku, JP). The FDA issued a Cleared decision on May 23, 2022, 788 days after receiving the submission on March 26, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K200788 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 26, 2020
Decision Date	May 23, 2022
Days to Decision	788 days
Submission Type	Dual Track
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	PZI — Prescription Use Blood Glucose Meter For Near-patient Testing
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1345
Definition	Intended For Use In Near-patient Testing Settings For In Vitro Diagnostic, Multiple-patient Use For The Quantitative Determination Of Glucose Throughout All Hospital And All Professional Healthcare Settings For Use In Determining Dysglycemia.