Cleared Traditional

K832691 - BETA SCAN REAGENT STRIP

K832691 is the FDA 510(k) clearance for BETA SCAN REAGENT STRIP by Orange Medical Instruments, Inc.. It is a Class 2 Hematology device (product code CGA) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K832691 · Orange Medical Instruments, Inc. · Hematology device
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Nov 1983
Decision
96d
Days
Class 2
Risk

K832691 is an FDA 510(k) clearance for the BETA SCAN REAGENT STRIP. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Orange Medical Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 14, 1983 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1345 - the FDA hematology device 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Orange Medical Instruments, Inc. devices

Submission Details

510(k) Number K832691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1983
Decision Date November 14, 1983
Days to Decision 96 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 113d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Hematology devices follow this clearance model.

Regulatory Peers - CGA Glucose Oxidase, Glucose

All 128
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K832691.
REFLOCHECK-S
K840962 · Boehringer Mannheim Corp. · Jun 1984
REFLOCHECK & GLUCOSE TEST STRIP SYS
K834271 · Boehringer Mannheim Corp. · Feb 1984
WAKO GLUCOSE C
K833257 · Wako Chemicals USA, Inc. · Dec 1983
TDX GLUCOSE
K833069 · Abbott Laboratories · Nov 1983
VISIDEX II REAGENT STRIPS
K831989 · Miles Laboratories, Inc. · Aug 1983
LANCER MSH GLUCOSE DIAG. KIT
K822958 · Sherwood Medical Co. · Nov 1982