Cleared Special

K163490 - StatStrip Xpress 2 Glucose Hospital Met...

K163490 is an FDA 510(k) clearance for StatStrip Xpress 2 Glucose Hospital Met..., manufactured by Nova Biomedical Corporation. The device is a Class 2 Chemistry device with product code PZI cleared through the Special 510(k) pathway after a 25-day FDA review.

K163490 · Nova Biomedical Corporation · Chemistry device
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Jan 2017
Decision
25d
Days
Class 2
Risk

K163490 is an FDA 510(k) clearance for the StatStrip Xpress 2 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 January 6, 2017 after a review of 25 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nova Biomedical Corporation devices

FDA 510(k) Submission Details - K163490

510(k) Number K163490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 88d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 K163490.
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 Glucose Hospital Meter System
K181043 · Nova Biomedical Corporation · Jul 2018
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 Xpress Glucose Hospital Meter System
K150461 · Nova Biomedical Corporation · May 2015