Cleared Dual Track

K181043 - StatStrip Glucose Hospital Meter System

K181043 is an FDA 510(k) clearance for StatStrip Glucose Hospital Meter System, manufactured by Nova Biomedical Corporation. The device is a Class 2 Chemistry device with product code PZI cleared through the Dual Track 510(k) pathway after a 84-day FDA review.

K181043 · Nova Biomedical Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
84d
Days
Class 2
Risk

K181043 is an FDA 510(k) clearance for the StatStrip Glucose Hospital Meter System. Classified as Prescription Use Blood Glucose Meter For Near-patient Testing (product code PZI), Class II - Special Controls.

Submitted by Nova Biomedical Corporation (Walham, US). The FDA issued a Cleared decision on July 12, 2018 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nova Biomedical Corporation devices

FDA 510(k) Submission Details - K181043

510(k) Number K181043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2018
Decision Date July 12, 2018
Days to Decision 84 days
Submission Type Dual Track
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 88d · This submission: 84d
Pathway characteristics

PZI Device Classification - Class 2, Special Controls

Product Code PZI Prescription Use Blood Glucose Meter For Near-patient Testing
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - PZI Prescription Use Blood Glucose Meter For Near-patient Testing

All 13
Devices cleared under the same product code (PZI) and FDA review panel - the closest regulatory comparables to K181043.
Assure Titanium Blood Glucose Monitoring System
K200788 · Arkray, Inc. · May 2022
StatStrip Xpress 2 Glucose Hospital Meter System
K182549 · Nova Biomedical Corporation · Dec 2018
StatStrip Xpress Glucose Hospital Meter System
K182552 · Nova Biomedical Corporation · Dec 2018
StatStrip Xpress 2 Glucose Hospital Meter System
K163490 · Nova Biomedical Corporation · Jan 2017
StatStrip Xpress Glucose Hospital Meter System
K161856 · Nova Biomedical Corporation · Nov 2016
StatStrip Xpress 2 Glucose Hospital Meter System
K152986 · Nova Biomedical Corporation · Jan 2016