Cleared Traditional

K101509 - U-RIGHT TD-4279 BLOOD GLUCOSE MONITORIN...

K101509 is the FDA 510(k) clearance for U-RIGHT TD-4279 BLOOD GLUCOSE MONITORIN... by Taidoc Technology Corporation. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 391-day FDA review.

K101509 · Taidoc Technology Corporation · Chemistry device
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Jun 2011
Decision
391d
Days
Class 2
Risk

K101509 is an FDA 510(k) clearance for the U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 BLOOD GLU.... Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Taidoc Technology Corporation (Taipei County, TW). The FDA issued a Cleared decision on June 27, 2011 after a review of 391 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 Taidoc Technology Corporation devices

Submission Details

510(k) Number K101509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2010
Decision Date June 27, 2011
Days to Decision 391 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
303d slower than avg
Panel avg: 88d · This submission: 391d
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 190
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K101509.
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FORA POCT MANAGMENT SYSTEM
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CLEVER CHOICE VOICE+ BLOOD GLUCOSE MONITORING SYSTEM
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HEALTH CARE SYSTEM SOFTWARE
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ON CALL PLUS DIABETES MONITORING SOFTWARE
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