Cleared Dual Track

cobas pulse blood glucose monitoring system

K220272 · Roche Diagnostics · Chemistry

Apr 2024

Decision

816d

Days

Class 2

Risk

About This 510(k) Submission

K220272 is an FDA 510(k) clearance for the cobas pulse blood glucose monitoring system, a Prescription Use Blood Glucose Meter For Near-patient Testing (Class II — Special Controls, product code PZI), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on April 26, 2024, 816 days after receiving the submission on January 31, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K220272 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 31, 2022
Decision Date	April 26, 2024
Days to Decision	816 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.