Cleared Special

K082482 - FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD...

K082482 is the FDA 510(k) clearance for FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD... by Taidoc Technology Corporation. It is a Class 2 Chemistry device (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.

View all Taidoc Technology Corporation devices

Submission Details

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
67d slower than avg
Panel avg: 88d · This submission: 155d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 190
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