Cleared Traditional

K862984 - UNIDEX GLUCOSE TEST STRIP

K862984 is an FDA 510(k) clearance for UNIDEX GLUCOSE TEST STRIP, manufactured by Unidex, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K862984

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.

CGA Device Classification - Class 2, Special Controls

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 317
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K862984.
GLUCOMETER-E
K863102 · J. D. Assoc. · Nov 1986
GLUCOSE OXIDASE
K863926 · Tech-Co, Inc. · Nov 1986
A-GENT(TM) LIQUID GLUCOSE TRINDER
K863948 · Abbott Laboratories · Nov 1986
ENZYMATIC BLOOD GLUCOSE
K862721 · U. S. Diagnostics, Inc. · Sep 1986
GAMBRO ANALYZ MON GLUCOSE/AM-G & DISP AM-G TUB SET
K860682 · Gambro, Inc. · Aug 1986
GLUCOMETER M BLOOD GULCOSE METER
K855202 · Miles Laboratories, Inc. · Jul 1986