Cleared Dual Track

XPER Technology PREMIUM Pro Blood Glucose Monitoring System (K221349) - FDA 510(k) Clearance

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

K221349 · Taidoc Technology Corporation · Chemistry device
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Nov 2024
Decision
925d
Days
Class 2
Risk

K221349 is an FDA 510(k) clearance for the XPER Technology PREMIUM Pro Blood Glucose Monitoring System. Classified as Prescription Use Blood Glucose Meter For Near-patient Testing (product code PZI), Class II - Special Controls.

Submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on November 19, 2024 after a review of 925 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Taidoc Technology Corporation devices

Submission Details

510(k) Number K221349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2022
Decision Date November 19, 2024
Days to Decision 925 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
837d slower than avg
Panel avg: 88d · This submission: 925d
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 K221349.
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StatStrip Xpress 2 Glucose Hospital Meter System
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StatStrip Xpress Glucose Hospital Meter System
K182552 · Nova Biomedical Corporation · Dec 2018
StatStrip Glucose Hospital Meter System
K181043 · Nova Biomedical Corporation · Jul 2018