Cleared Traditional

K092688 - FORA POCT S10/TD-4258 BLOOD GLUCOSE MON...

K092688 is the FDA 510(k) clearance for FORA POCT S10/TD-4258 BLOOD GLUCOSE MON... by Taidoc Technology Corporation. It is a Class 2 Chemistry device (product code LFR) cleared through the Traditional 510(k) pathway after a 673-day FDA review.

K092688 · Taidoc Technology Corporation · Chemistry device
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Jul 2011
Decision
673d
Days
Class 2
Risk

K092688 is an FDA 510(k) clearance for the FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM. Classified as Glucose Dehydrogenase, Glucose (product code LFR), Class II - Special Controls.

Submitted by Taidoc Technology Corporation (Taipei County, TW). The FDA issued a Cleared decision on July 6, 2011 after a review of 673 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Taidoc Technology Corporation devices

Submission Details

510(k) Number K092688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2009
Decision Date July 06, 2011
Days to Decision 673 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
585d slower than avg
Panel avg: 88d · This submission: 673d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LFR Glucose Dehydrogenase, 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 - LFR Glucose Dehydrogenase, Glucose

All 40
Devices cleared under the same product code (LFR) and FDA review panel - the closest regulatory comparables to K092688.
CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)
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K101299 · Roche Diagnostics · Sep 2011
MODIFICATION TO ACCU-CHEK GO SYSTEM
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ACCU-CHEK INTEGRA SYSTEM
K050872 · Roche Diagnostics Corp. · May 2005
ACCU-CHEK AVIVA SYSTEM
K043474 · Roche Diagnostics Corp. · Apr 2005