Cleared Traditional

K893404 - INTEGRA(TM) BLOOD GLUCOSE MONITORING SYSTEM

K893404 is an FDA 510(k) clearance for INTEGRA(TM) BLOOD GLUCOSE MONITORING SYSTEM, manufactured by Apprise, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K893404 · Apprise, Inc. · Chemistry device
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Aug 1989
Decision
93d
Days
Class 2
Risk

K893404 is an FDA 510(k) clearance for the INTEGRA(TM) BLOOD GLUCOSE MONITORING SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Apprise, Inc. (Santa Clara, US). The FDA issued a Cleared decision on August 3, 1989 after a review of 93 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 Apprise, Inc. devices

FDA 510(k) Submission Details - K893404

510(k) Number K893404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1989
Decision Date August 03, 1989
Days to Decision 93 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 88d · This submission: 93d
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 313
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K893404.
ONE TOUCH II METER
K895911 · Lifescan, Inc. · Nov 1989
COBAS READY GLUCOSE REAGENT
K895526 · Roche Diagnostic Systems, Inc. · Oct 1989
FIRST CHOICE (TM)
K893205 · Polymer Technology Corp. · Oct 1989
GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST
K893117 · Bayer Corp. · Jun 1989
NEOCHROME(R) III GLUCOSE
K892002 · American Monitor Corp. · Jun 1989
YSI MODEL 2300 STAT GLUCOSE AND L-LACTATE ANALYZER
K891480 · Yellow Springs Instrument Co., Inc. · May 1989