Cleared Traditional

K163087 - PixoTest Blood Glucose Monitoring System

K163087 is the FDA 510(k) clearance for PixoTest Blood Glucose Monitoring System by Ixensor Company , Ltd.. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 364-day FDA review.

K163087 · Ixensor Company , Ltd. · Chemistry device
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Nov 2017
Decision
364d
Days
Class 2
Risk

K163087 is an FDA 510(k) clearance for the PixoTest Blood Glucose Monitoring System. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Ixensor Company , Ltd. (Taipei City, TW). The FDA issued a Cleared decision on November 2, 2017 after a review of 364 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Ixensor Company , Ltd. devices

Submission Details

510(k) Number K163087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2016
Decision Date November 02, 2017
Days to Decision 364 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
276d slower than avg
Panel avg: 88d · This submission: 364d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NBW System, Test, Blood Glucose, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 - NBW System, Test, Blood Glucose, Over The Counter

All 236
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