Cleared Special

StatStrip Xpress Glucose Hospital Meter System

K161856 · Nova Biomedical Corporation · Chemistry

Nov 2016

Decision

132d

Days

Class 2

Risk

About This 510(k) Submission

K161856 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 November 15, 2016, 132 days after receiving the submission on July 6, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K161856 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 06, 2016
Decision Date	November 15, 2016
Days to Decision	132 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.