Cleared Traditional

K952279 - PRECISION LINK BLOOD GLUCOSE DATA MANAG...

K952279 is the FDA 510(k) clearance for PRECISION LINK BLOOD GLUCOSE DATA MANAG... by Medisense, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K952279 · Medisense, Inc. · Chemistry device
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Jun 1995
Decision
64d
Days
Class 2
Risk

K952279 is an FDA 510(k) clearance for the PRECISION LINK BLOOD GLUCOSE DATA MANAGEMENT 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 June 14, 1995 after a review of 64 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 Medisense, Inc. devices

Submission Details

510(k) Number K952279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1995
Decision Date June 14, 1995
Days to Decision 64 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
24d faster than avg
Panel avg: 88d · This submission: 64d
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 K952279.
WAKO AUTOKIT GLUCOSE
K950172 · Wako Chemicals USA, Inc. · Oct 1995
GLUCOMETER ELITE M BLOOD GLUCOSE METER
K951537 · Bayer Corp. · Jul 1995
ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
K950816 · Lifescan, Inc. · Jul 1995
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