Cleared Traditional

K150461 - StatStrip Xpress Glucose Hospital Meter...

K150461 is the FDA 510(k) clearance for StatStrip Xpress Glucose Hospital Meter... by Nova Biomedical Corporation. It is a Class 2 Chemistry device (product code PZI) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K150461 · Nova Biomedical Corporation · Chemistry device
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May 2015
Decision
86d
Days
Class 2
Risk

K150461 is an FDA 510(k) clearance for the StatStrip Xpress 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 May 20, 2015 after a review of 86 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 K150461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2015
Decision Date May 20, 2015
Days to Decision 86 days
Submission Type Traditional
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
2d faster than avg
Panel avg: 88d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 13
Devices cleared under the same product code (PZI) and FDA review panel - the closest regulatory comparables to K150461.
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
StatStrip Glucose Hospital Meter
K150281 · Nova Biomedical Corporation · May 2015
STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
K132121 · Nova Biomedical Corporation · Sep 2014