Cleared Traditional

K840484 - DIATRON EASYTEST BLOOD GLUCOSE MONI

K840484 is an FDA 510(k) clearance for DIATRON EASYTEST BLOOD GLUCOSE MONI, manufactured by Medivix, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K840484 · Medivix, Inc. · Chemistry device
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Jun 1984
Decision
137d
Days
Class 2
Risk

K840484 is an FDA 510(k) clearance for the DIATRON EASYTEST BLOOD GLUCOSE MONI. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Medivix, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1984 after a review of 137 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 Medivix, Inc. devices

FDA 510(k) Submission Details - K840484

510(k) Number K840484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1984
Decision Date June 22, 1984
Days to Decision 137 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 88d · This submission: 137d
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 313
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K840484.
BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE
K842393 · Boehringer Mannheim Corp. · Aug 1984
GLUCOSE-TRINDER-ADDAY KIT
K842506 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1984
WAKO B.G. PRETEST STRIPS
K842207 · Healthdyne, Inc. · Jun 1984
REFLOCHECK-S
K840962 · Boehringer Mannheim Corp. · Jun 1984
GLUCOSE ENZYMATIC REAGENT SET
K841055 · Medical Specialties, Inc. · May 1984
REFLOCHECK & GLUCOSE TEST STRIP SYS
K834271 · Boehringer Mannheim Corp. · Feb 1984