Cleared Traditional

K031472 - ONE TOUCH BASIC/PROFILE/ONE TOUCH II TE...

K031472 is the FDA 510(k) clearance for ONE TOUCH BASIC/PROFILE/ONE TOUCH II TE... by Lifescan, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K031472 · Lifescan, Inc. · Chemistry device
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Aug 2003
Decision
88d
Days
Class 2
Risk

K031472 is an FDA 510(k) clearance for the ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Lifescan, Inc. (Milpitas, US). The FDA issued a Cleared decision on August 5, 2003 after a review of 88 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.

View all Lifescan, Inc. devices

Submission Details

510(k) Number K031472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2003
Decision Date August 05, 2003
Days to Decision 88 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 88d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 133
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