Cleared Traditional

UNIDEX GLUCOSE TEST STRIP (K862984) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K862984 · Unidex, Inc. · Chemistry device
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Nov 1986
Decision
90d
Days
Class 2
Risk

K862984 is an FDA 510(k) clearance for the UNIDEX GLUCOSE TEST STRIP. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Unidex, Inc. (Bellevue, US). The FDA issued a Cleared decision on November 5, 1986 after a review of 90 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 Unidex, Inc. devices

Submission Details

510(k) Number K862984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1986
Decision Date November 05, 1986
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 88d · This submission: 90d
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 70
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K862984.
TRACKER SYSTEM
K860948 · Boehringer Mannheim Corp. · Dec 1986
EXACTECH(TM)
K863468 · Travenol Laboratories, S.A. · Dec 1986
A-GENT(TM) LIQUID GLUCOSE TRINDER
K863948 · Abbott Laboratories · Nov 1986
GLUCOMETER M BLOOD GULCOSE METER
K855202 · Miles Laboratories, Inc. · Jul 1986
GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER
K861303 · Miles Laboratories, Inc. · Jul 1986
QCA ENZYMATIC GLUCOSE
K853656 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1985