Cleared Dual Track

K181043 - StatStrip Glucose Hospital Meter System (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Dual Track 510(k) pathway - typically does not require clinical trials.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 88d · This submission: 84d
Pathway characteristics

Device Classification

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 12
Devices cleared under the same product code (PZI) and FDA review panel - the closest regulatory comparables to K181043.
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