Cleared Dual Track

StatStrip Xpress Glucose Hospital Meter System

K182552 · Nova Biomedical Corporation · Chemistry

Dec 2018

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K182552 is an FDA 510(k) clearance for the StatStrip Xpress Glucose Hospital Meter System, a Prescription Use Blood Glucose Meter For Near-patient Testing (Class II — Special Controls, product code PZI), submitted by Nova Biomedical Corporation (Walham, US). The FDA issued a Cleared decision on December 13, 2018, 87 days after receiving the submission on September 17, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K182552 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 17, 2018
Decision Date	December 13, 2018
Days to Decision	87 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.