Cleared Dual Track

XPER Technology PREMIUM Pro Blood Glucose Monitoring System

K221349 · Taidoc Technology Corporation · Chemistry

Nov 2024

Decision

925d

Days

Class 2

Risk

About This 510(k) Submission

K221349 is an FDA 510(k) clearance for the XPER Technology PREMIUM Pro Blood Glucose Monitoring System, a Prescription Use Blood Glucose Meter For Near-patient Testing (Class II — Special Controls, product code PZI), submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on November 19, 2024, 925 days after receiving the submission on May 9, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K221349 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 09, 2022
Decision Date	November 19, 2024
Days to Decision	925 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.