Cleared Traditional

K841369 - BETA SCAN DRYSTIX

K841369 is an FDA 510(k) clearance for BETA SCAN DRYSTIX, manufactured by Orange Medical Instruments, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K841369 · Orange Medical Instruments, Inc. · Chemistry device
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Aug 1984
Decision
142d
Days
Class 2
Risk

K841369 is an FDA 510(k) clearance for the BETA SCAN DRYSTIX. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Orange Medical Instruments, Inc. (Walker, US). The FDA issued a Cleared decision on August 23, 1984 after a review of 142 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 Orange Medical Instruments, Inc. devices

FDA 510(k) Submission Details - K841369

510(k) Number K841369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1984
Decision Date August 23, 1984
Days to Decision 142 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 88d · This submission: 142d
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 308
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K841369.
GLUCOSE - TRINDER- REAGENT
K850364 · Sigma Chemical Co. · Mar 1985
DIATROL BLOOD GLUCOSE TEST SYS
K842684 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1984
SYSTEMATE GLUCOSE 67215
K843151 · Em Diagnostic Systems, Inc. · Aug 1984
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