Cleared Traditional

K863481 - MODIFICATION OF ACCU-CHEK II

K863481 is an FDA 510(k) clearance for MODIFICATION OF ACCU-CHEK II, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K863481 · Boehringer Mannheim Corp. · Chemistry device
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Optimized for regulatory review, auditing and printing
Apr 1987
Decision
210d
Days
Class 2
Risk

K863481 is an FDA 510(k) clearance for the MODIFICATION OF ACCU-CHEK II. 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 April 7, 1987 after a review of 210 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K863481

510(k) Number K863481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1986
Decision Date April 07, 1987
Days to Decision 210 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
122d slower than avg
Panel avg: 88d · This submission: 210d
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 206
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K863481.
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GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT
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K873117 · Biotrol, USA, Inc. · Aug 1987
FAST GLUCOSE
K870631 · Sclavo, Inc. · Mar 1987
MPX SYSTEM, GLUCOSE TEST SYSTEM
K864322 · Lifescan, Inc. · Feb 1987
SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI.
K864530 · Miles Laboratories, Inc. · Feb 1987