Cleared Traditional

K895911 - ONE TOUCH II METER

K895911 is an FDA 510(k) clearance for ONE TOUCH II METER, 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 29-day FDA review.

K895911 · Lifescan, Inc. · Chemistry device
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Nov 1989
Decision
29d
Days
Class 2
Risk

K895911 is an FDA 510(k) clearance for the ONE TOUCH II METER. 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 November 8, 1989 after a review of 29 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 Lifescan, Inc. devices

FDA 510(k) Submission Details - K895911

510(k) Number K895911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1989
Decision Date November 08, 1989
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 88d · This submission: 29d
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 K895911.
ACCU-CHEK (R) EASY (TM) BLOOD GLUCOSE SYSTEM
K904168 · Boehringer Mannheim Corp. · Oct 1990
SYNERMED GLUCOSE REAGENT KIT
K903063 · Synermed, Inc. · Sep 1990
GLUCOMETER GX BLOOD GLUCOSE METER
K897015 · Heraeus Kulzer, Inc. · Mar 1990
COBAS READY GLUCOSE REAGENT
K895526 · Roche Diagnostic Systems, Inc. · Oct 1989
FIRST CHOICE (TM)
K893205 · Polymer Technology Corp. · Oct 1989
GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST
K893117 · Bayer Corp. · Jun 1989