Cleared Traditional

K072784 - PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4227, CLEVER CHEK TD-4227 BLOOD GLUCOSE MONITORING SYSTEM

K072784 is an FDA 510(k) clearance for PRODIGY AUTOCODE BLOOD GLUCOSE MONITORI..., manufactured by Taidoc Technology Corporation. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K072784 · Taidoc Technology Corporation · Chemistry device
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Dec 2007
Decision
81d
Days
Class 2
Risk

K072784 is an FDA 510(k) clearance for the PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4227, CLEVER CHEK .... Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Taidoc Technology Corporation (San Chung, Taipei, TW). The FDA issued a Cleared decision on December 21, 2007 after a review of 81 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Taidoc Technology Corporation devices

FDA 510(k) Submission Details - K072784

510(k) Number K072784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2007
Decision Date December 21, 2007
Days to Decision 81 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 88d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NBW Device Classification - Class 2, Special Controls

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 420
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