Cleared Special

StatStrip Xpress 2 Glucose Hospital Meter System

K163490 · Nova Biomedical Corporation · Chemistry

Jan 2017

Decision

25d

Days

Class 2

Risk

About This 510(k) Submission

K163490 is an FDA 510(k) clearance for the StatStrip Xpress 2 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 January 6, 2017, 25 days after receiving the submission on December 12, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K163490 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 12, 2016
Decision Date	January 06, 2017
Days to Decision	25 days
Submission Type	Special
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.