Cleared Traditional

K832691 - BETA SCAN REAGENT STRIP

K832691 is an FDA 510(k) clearance for BETA SCAN REAGENT STRIP, manufactured by Orange Medical Instruments, Inc.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K832691

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.

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 Hematology devices follow this clearance model.

Regulatory Peers - CGA Glucose Oxidase, Glucose

All 307
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K832691.
GLUCOSE ENZYMATIC REAGENT SET
K841055 · Medical Specialties, Inc. · May 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
GLUCOKEY
K831194 · Ulster Scientific, Inc. · Oct 1983
ENZYMATIC GLUCOSE DETERMINATION
K832926 · Seragen Diagnostics, Inc. · Oct 1983