Cleared Traditional

K842506 - GLUCOSE-TRINDER-ADDAY KIT

K842506 is the FDA 510(k) clearance for GLUCOSE-TRINDER-ADDAY KIT by Diagnostic Chemicals, Ltd. (Usa). It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K842506 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry device
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Jul 1984
Decision
23d
Days
Class 2
Risk

K842506 is an FDA 510(k) clearance for the GLUCOSE-TRINDER-ADDAY KIT. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Diagnostic Chemicals, Ltd. (Usa) (Canada, US). The FDA issued a Cleared decision on July 19, 1984 after a review of 23 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Diagnostic Chemicals, Ltd. (Usa) devices

Submission Details

510(k) Number K842506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1984
Decision Date July 19, 1984
Days to Decision 23 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
65d faster than avg
Panel avg: 88d · This submission: 23d
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 192
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K842506.
DIATROL BLOOD GLUCOSE TEST SYS
K842684 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1984
SYSTEMATE GLUCOSE 67215
K843151 · Em Diagnostic Systems, Inc. · Aug 1984
BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE
K842393 · Boehringer Mannheim Corp. · Aug 1984
WAKO B.G. PRETEST STRIPS
K842207 · Healthdyne, Inc. · Jun 1984
REFLOCHECK-S
K840962 · Boehringer Mannheim Corp. · Jun 1984
GLUCOSE ENZYMATIC REAGENT SET
K841055 · Medical Specialties, Inc. · May 1984