Cleared Traditional

K851703 - GLUCOSTIX REAGENT STRIPS & GLUCOMETER R...

K851703 is the FDA 510(k) clearance for GLUCOSTIX REAGENT STRIPS & GLUCOMETER R... by Miles Laboratories, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K851703 · Miles Laboratories, Inc. · Chemistry device
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Aug 1985
Decision
121d
Days
Class 2
Risk

K851703 is an FDA 510(k) clearance for the GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Elkhart, US). The FDA issued a Cleared decision on August 23, 1985 after a review of 121 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K851703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1985
Decision Date August 23, 1985
Days to Decision 121 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 88d · This submission: 121d
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 190
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K851703.
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
ACCU-CHEK II
K851456 · Boehringer Mannheim Corp. · Aug 1985
GLUCOSE(TRINDER) REAGENT
K852130 · Sigma Diagnostics, Inc. · Jun 1985
GLUCOSE - TRINDER- REAGENT
K850364 · Sigma Chemical Co. · Mar 1985