Cleared Traditional

K851456 - ACCU-CHEK II

K851456 is an FDA 510(k) clearance for 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 112-day FDA review.

K851456 · Boehringer Mannheim Corp. · Chemistry device
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Aug 1985
Decision
112d
Days
Class 2
Risk

K851456 is an FDA 510(k) clearance for the 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 August 1, 1985 after a review of 112 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

FDA 510(k) Submission Details - K851456

510(k) Number K851456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1985
Decision Date August 01, 1985
Days to Decision 112 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
24d slower than avg
Panel avg: 88d · This submission: 112d
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 K851456.
GLUCOSE REAGENT SET (GOD/TRINDER)
K854335 · Sterling Diagnostics, Inc. · Nov 1985
QCA ENZYMATIC GLUCOSE
K853656 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1985
GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT
K851703 · Miles Laboratories, Inc. · Aug 1985
GLUCOSE(TRINDER) REAGENT
K852130 · Sigma Diagnostics, Inc. · Jun 1985
GLU(GOD) REAGENT
K851992 · Alpkem Corp. · May 1985
GLUCOSE - TRINDER- REAGENT
K850364 · Sigma Chemical Co. · Mar 1985