Cleared Traditional

K944195 - QUICKPRO BLOOD GLUCOSE TESTING SYSTEM

K944195 is the FDA 510(k) clearance for QUICKPRO BLOOD GLUCOSE TESTING SYSTEM by Medisense, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K944195 · Medisense, Inc. · Chemistry device
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Mar 1995
Decision
206d
Days
Class 2
Risk

K944195 is an FDA 510(k) clearance for the QUICKPRO BLOOD GLUCOSE TESTING SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Medisense, Inc. (Waltham, US). The FDA issued a Cleared decision on March 23, 1995 after a review of 206 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 Medisense, Inc. devices

Submission Details

510(k) Number K944195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1994
Decision Date March 23, 1995
Days to Decision 206 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 88d · This submission: 206d
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 191
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K944195.
ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
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LIFESCAN SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
K942455 · Lifescan, Inc. · Mar 1995
SIGMA GLUCOSE REAGENT
K933694 · Sigma Chemical Co. · Nov 1994
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K943241 · Data Medical Associates, Inc. · Oct 1994
GLUCOFILM TEST STRIPS
K936212 · Heraeus Kulzer, Inc. · May 1994