Cleared Traditional

K070941 - CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0

K070941 is an FDA 510(k) clearance for CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, 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 78-day FDA review.

K070941 · Taidoc Technology Corporation · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
78d
Days
Class 2
Risk

K070941 is an FDA 510(k) clearance for the CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0. 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 June 21, 2007 after a review of 78 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.

FDA 510(k) Submission Details - K070941

510(k) Number K070941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2007
Decision Date June 21, 2007
Days to Decision 78 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
11d faster than avg
Panel avg: 89d · This submission: 78d
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 513
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K070941.
MEDAPPS REMOTE PATIENT MONITORING, MODEL MA 100
K062377 · Medapps, Inc. · Jul 2007
POLYMAP PWR-08-03
K070559 · Polymap Wireless · Jun 2007
MICRODOT BLOOD GLUCOSE MONITORING SYSTEM
K070524 · Cambridge Sensors Limited · Jun 2007
NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002
K070255 · Nova Biomedical Corp. · Jun 2007
MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM
K070239 · Exir Pharmaceutical Co. · May 2007
ACCU-CHEK PERFORMA SYSTEM
K070585 · Roche Diagnostics Corp. · May 2007
K070941 · CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0
Download PDF FDA Summary Taidoc Technology Cor…