Cleared Special

K082482 - FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4251/TD-4252A/TD-4252B/TD-4254

K082482 is an FDA 510(k) clearance for FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD..., manufactured by Taidoc Technology Corporation. The device is a Class 2 Chemistry device with product code CGA cleared through the Special 510(k) pathway after a 155-day FDA review.

K082482 · Taidoc Technology Corporation · Chemistry device
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Jan 2009
Decision
155d
Days
Class 2
Risk

K082482 is an FDA 510(k) clearance for the FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM,.... Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Taidoc Technology Corporation (Taipei County, TW). The FDA issued a Cleared decision on January 30, 2009 after a review of 155 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K082482

510(k) Number K082482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2008
Decision Date January 30, 2009
Days to Decision 155 days
Submission Type Special
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
66d slower than avg
Panel avg: 89d · This submission: 155d
Pathway characteristics
Modification to existing cleared device.

CGA Device Classification - Class 2, Special Controls

Product Code CGA Glucose Oxidase, Glucose
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 - CGA Glucose Oxidase, Glucose

All 400
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K082482 · FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4251/TD-4252A/TD-4252B/TD-4254
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