Cleared Traditional

K011479 - ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM

K011479 is an FDA 510(k) clearance for ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOS..., manufactured by Inverness Medical Innovations, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K011479 · Inverness Medical Innovations, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
200d
Days
Class 2
Risk

K011479 is an FDA 510(k) clearance for the ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA B.... Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Inverness Medical Innovations, Inc. (Waltham, US). The FDA issued a Cleared decision on November 30, 2001 after a review of 200 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Inverness Medical Innovations, Inc. devices

FDA 510(k) Submission Details - K011479

510(k) Number K011479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2001
Decision Date November 30, 2001
Days to Decision 200 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
112d slower than avg
Panel avg: 88d · This submission: 200d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 305
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