Cleared Traditional

K904168 - ACCU-CHEK EASY (TM) BLOOD GLUCOSE SYSTEM

K904168 is an FDA 510(k) clearance for ACCU-CHEK EASY (TM) BLOOD GLUCOSE SYSTEM, 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 34-day FDA review.

K904168 · Boehringer Mannheim Corp. · Chemistry device
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Oct 1990
Decision
34d
Days
Class 2
Risk

K904168 is an FDA 510(k) clearance for the ACCU-CHEK (R) EASY (TM) BLOOD GLUCOSE 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 October 15, 1990 after a review of 34 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K904168

510(k) Number K904168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1990
Decision Date October 15, 1990
Days to Decision 34 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
54d faster than avg
Panel avg: 88d · This submission: 34d
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 K904168.
ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST
K913357 · Lifescan, Inc. · Nov 1991
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
SYNERMED GLUCOSE REAGENT KIT
K903063 · Synermed, Inc. · Sep 1990
GLUCOMETER GX BLOOD GLUCOSE METER
K897015 · Heraeus Kulzer, Inc. · Mar 1990
ONE TOUCH II METER
K895911 · Lifescan, Inc. · Nov 1989