Cleared Traditional

K851618 - DIASCAN BLOOD GLUCOSE SELF-MONITOR TEST...

K851618 is the FDA 510(k) clearance for DIASCAN BLOOD GLUCOSE SELF-MONITOR TEST... by Home Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K851618 · Home Diagnostics, Inc. · Chemistry device
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Aug 1985
Decision
110d
Days
Class 2
Risk

K851618 is an FDA 510(k) clearance for the DIASCAN BLOOD GLUCOSE SELF-MONITOR TEST STRIPS. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Home Diagnostics, Inc. (Eatontown, US). The FDA issued a Cleared decision on August 6, 1985 after a review of 110 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 Home Diagnostics, Inc. devices

Submission Details

510(k) Number K851618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1985
Decision Date August 06, 1985
Days to Decision 110 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 88d · This submission: 110d
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 197
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K851618.
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
ACCU-CHEK II
K851456 · Boehringer Mannheim Corp. · Aug 1985
GLUCOSE(TRINDER) REAGENT
K852130 · Sigma Diagnostics, Inc. · Jun 1985
GLU(GOD) REAGENT
K851992 · Alpkem Corp. · May 1985