Cleared Special

K083570 - U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD G...

K083570 is the FDA 510(k) clearance for U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD G... by Taidoc Technology Corporation. It is a Class 2 Chemistry device (product code CGA) cleared through the Special 510(k) pathway after a 98-day FDA review.

K083570 · Taidoc Technology Corporation · Chemistry device
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Mar 2009
Decision
98d
Days
Class 2
Risk

K083570 is an FDA 510(k) clearance for the U-RIGHT TD-4249/U-RIGHT TD-4250 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 March 11, 2009 after a review of 98 days - within the typical 510(k) review window.

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 K083570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2008
Decision Date March 11, 2009
Days to Decision 98 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
10d slower than avg
Panel avg: 88d · This submission: 98d
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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