Cleared Dual Track

K232075 - 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.

K232075 · Nova Biomedical Corporation · Chemistry device
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Optimized for regulatory review, auditing and printing
Feb 2024
Decision
226d
Days
Class 2
Risk

K232075 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 February 23, 2024 after a review of 226 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K232075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2023
Decision Date February 23, 2024
Days to Decision 226 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
138d slower than avg
Panel avg: 88d · This submission: 226d
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.