Cleared Traditional

ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM (K883817) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K883817 · Boehringer Mannheim Corp. · Chemistry device
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Dec 1988
Decision
92d
Days
Class 2
Risk

K883817 is an FDA 510(k) clearance for the ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on December 9, 1988 after a review of 92 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 Boehringer Mannheim Corp. devices

Submission Details

510(k) Number K883817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1988
Decision Date December 09, 1988
Days to Decision 92 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
4d slower than avg
Panel avg: 88d · This submission: 92d
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 83
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K883817.
GLUCOFILM TEST STRIPS & CONTROLS/GLUCOMETER 3
K890873 · Heraeus Kulzer, Inc. · Apr 1989
ROCHE CHLORIDE ELECTRODE
K890528 · Roche Diagnostic Systems, Inc. · Mar 1989
CLINISTAT GLUCOSE REAGENT TEST
K884756 · Heraeus Kulzer, Inc. · Jan 1989
TRACER(TM) II BLOOD GLUCOSE SYSTEM
K881908 · Boehringer Mannheim Corp. · Jul 1988
GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT
K871835 · Miles Laboratories, Inc. · Dec 1987
MODIFICATION OF ACCU-CHEK II
K863481 · Boehringer Mannheim Corp. · Apr 1987