Cleared Traditional

K851822 - BETA SCAN TRENDS METER

K851822 is the FDA 510(k) clearance for BETA SCAN TRENDS METER by Orange Medical Instruments, Inc.. It is a Class 2 Chemistry device (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

Submission Details

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.

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 Chemistry devices follow this clearance model.

Regulatory Peers - CGA Glucose Oxidase, Glucose

All 127
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K851822.
GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER
K861303 · Miles Laboratories, Inc. · Jul 1986
GLUCOSE HK PROCEDURE
K861653 · Data Medical Associates, Inc. · May 1986
GLUCOSE OXIDASE PROCEDURE
K861204 · Data Medical Associates, Inc. · Apr 1986
QCA ENZYMATIC GLUCOSE
K853656 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1985
GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT
K851703 · Miles Laboratories, Inc. · Aug 1985
ACCU-CHEK II
K851456 · Boehringer Mannheim Corp. · Aug 1985