Cleared Traditional

K950727 - ONE TOUCH PROFILE COMPLETE DIABETES TRA...

K950727 is the FDA 510(k) clearance for ONE TOUCH PROFILE COMPLETE DIABETES TRA... by Lifescan, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K950727 · Lifescan, Inc. · Chemistry device
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Jun 1995
Decision
105d
Days
Class 2
Risk

K950727 is an FDA 510(k) clearance for the ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM. 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 June 1, 1995 after a review of 105 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. 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 Lifescan, Inc. devices

Submission Details

510(k) Number K950727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1995
Decision Date June 01, 1995
Days to Decision 105 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
17d slower than avg
Panel avg: 88d · This submission: 105d
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
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K950727.
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GLUCOMETER ELITE M BLOOD GLUCOSE METER
K951537 · Bayer Corp. · Jul 1995
SIGMA GLUCOSE REAGENT
K933694 · Sigma Chemical Co. · Nov 1994
DMA GLUCOSE (OXIDASE) PROCEDURE
K943241 · Data Medical Associates, Inc. · Oct 1994
GLUCOFILM TEST STRIPS
K936212 · Heraeus Kulzer, Inc. · May 1994