Cleared Traditional

K913357 - ONE TOUCH II HOSPITAL BLOOD GLUCOSE MON...

K913357 is the FDA 510(k) clearance for ONE TOUCH II HOSPITAL BLOOD GLUCOSE MON... by Lifescan, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K913357 · Lifescan, Inc. · Chemistry device
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Nov 1991
Decision
101d
Days
Class 2
Risk

K913357 is an FDA 510(k) clearance for the ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST. 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 7, 1991 after a review of 101 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 K913357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1991
Decision Date November 07, 1991
Days to Decision 101 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
13d slower than avg
Panel avg: 88d · This submission: 101d
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 K913357.
ACCU-CHEK EASY BLOOD GLUCOSE SYSTEM
K923048 · Boehringer Mannheim Corp. · Oct 1992
ACCUDATA GLUCOSE TEST STATION
K924475 · Boehringer Mannheim Corp. · Oct 1992
IL TEST GLUCOSE, PN 181633-80
K922532 · Instrumentation Laboratory CO · Sep 1992
GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM
K904081 · Heraeus Kulzer, Inc. · Dec 1990
ACCU-CHEK(R) III BLOOD GLUCOSE SYSTEM
K904292 · Boehringer Mannheim Corp. · Oct 1990
ACCU-CHEK (R) EASY (TM) BLOOD GLUCOSE SYSTEM
K904168 · Boehringer Mannheim Corp. · Oct 1990