Cleared Traditional

K904081 - GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM

K904081 is an FDA 510(k) clearance for GLUCOMETER QA BLOOD GLUCOSE METER AND G..., manufactured by Heraeus Kulzer, Inc.. 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.

K904081 · Heraeus Kulzer, Inc. · Chemistry device
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Dec 1990
Decision
112d
Days
Class 2
Risk

K904081 is an FDA 510(k) clearance for the GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Elkhart, US). The FDA issued a Cleared decision on December 26, 1990 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 Heraeus Kulzer, Inc. devices

FDA 510(k) Submission Details - K904081

510(k) Number K904081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1990
Decision Date December 26, 1990
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 316
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K904081.
ULTRA BLOOD GLUCOSE MONITORING SYSTEM
K912440 · Home Diagnostics, Inc. · Jul 1991
FIRST CHOICE(TM), MODIFICATION
K911792 · Polymer Technology Corp. · May 1991
YSI MODEL 1500 BLOOD GLUCOSE ANALYZER
K910633 · Yellow Springs Instrument Co., Inc. · Apr 1991
CHOLESTECH LIPID MONITORING SYSTEM, GLUCOSE TEST
K904082 · Cholestech Corp. · 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