Cleared Traditional

K041107 - TAIDOC CHECK

K041107 is the FDA 510(k) clearance for TAIDOC CHECK by Taidoc Technology Corporation. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K041107 · Taidoc Technology Corporation · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
51d
Days
Class 2
Risk

K041107 is an FDA 510(k) clearance for the TAIDOC CHECK. 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 18, 2004 after a review of 51 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

Submission Details

510(k) Number K041107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2004
Decision Date June 18, 2004
Days to Decision 51 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
37d faster than avg
Panel avg: 88d · This submission: 51d
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 235
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K041107.
ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM
K043158 · Bayer Healthcare, LLC · Dec 2004
ASCENSIA ELITE DIABETES CARE SYSTEM
K043311 · Bayer Healthcare, LLC · Dec 2004
ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222
K042005 · Taidoc Technology Corporation · Aug 2004
PARADIGM LINK BLOOD GLUCOSE METER
K040603 · Becton, Dickinson & CO · May 2004
MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM
K040814 · Abbott Laboratories · Apr 2004
PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM
K040628 · Abbott Laboratories · Mar 2004