Cleared Traditional

K851822 - BETA SCAN TRENDS METER

K851822 is an FDA 510(k) clearance for BETA SCAN TRENDS METER, 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 160-day FDA review.

K851822 · Orange Medical Instruments, Inc. · Chemistry device
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Oct 1985
Decision
160d
Days
Class 2
Risk

K851822 is an FDA 510(k) clearance for the BETA SCAN TRENDS METER. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Orange Medical Instruments, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on October 3, 1985 after a review of 160 days - an extended review cycle.

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 - K851822

510(k) Number K851822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1985
Decision Date October 03, 1985
Days to Decision 160 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 88d · This submission: 160d
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 K851822.
GLUCOSE OXIDASE REAGENT SET
K855194 · Technostics Intl. · Jan 1986
IN-VITRO TEST FOR THE DETERMINATION OF GLUCOSE
K854177 · Clinical Data, Inc. · Nov 1985
GLUCOSE REAGENT SET (GOD/TRINDER)
K854335 · Sterling Diagnostics, Inc. · Nov 1985
QCA ENZYMATIC GLUCOSE
K853656 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1985
GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT
K851703 · Miles Laboratories, Inc. · Aug 1985
DIASCAN BLOOD GLUCOSE SELF-MONITOR TEST STRIPS
K851618 · Home Diagnostics, Inc. · Aug 1985