Cleared Traditional

K950816 - ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM

K950816 is an FDA 510(k) clearance for ONE TOUCH II HOSPITAL BLOOD GLUCOSE MON..., manufactured by Lifescan, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K950816 · Lifescan, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
131d
Days
Class 2
Risk

K950816 is an FDA 510(k) clearance for the ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING 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 July 3, 1995 after a review of 131 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

FDA 510(k) Submission Details - K950816

510(k) Number K950816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1995
Decision Date July 03, 1995
Days to Decision 131 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
43d slower than avg
Panel avg: 88d · This submission: 131d
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 285
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K950816.
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GLUCOMETER ELITE M BLOOD GLUCOSE METER
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ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM
K950727 · Lifescan, Inc. · Jun 1995
LIFESCAN SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
K942455 · Lifescan, Inc. · Mar 1995
SIGMA GLUCOSE REAGENT
K933694 · Sigma Chemical Co. · Nov 1994