Cleared Traditional

K890528 - ROCHE CHLORIDE ELECTRODE

K890528 is the FDA 510(k) clearance for ROCHE CHLORIDE ELECTRODE by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K890528 · Roche Diagnostic Systems, Inc. · Chemistry device
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Mar 1989
Decision
57d
Days
Class 2
Risk

K890528 is an FDA 510(k) clearance for the ROCHE CHLORIDE ELECTRODE. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on March 31, 1989 after a review of 57 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K890528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1989
Decision Date March 31, 1989
Days to Decision 57 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
31d faster than avg
Panel avg: 88d · This submission: 57d
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 166
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K890528.
GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST
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K892002 · American Monitor Corp. · Jun 1989
GLUCOFILM TEST STRIPS & CONTROLS/GLUCOMETER 3
K890873 · Heraeus Kulzer, Inc. · Apr 1989
GLUCOSE-SUPER FAST 4983050 AND 4983500
K882262 · American Research Products Co. · Feb 1989
CLINISTAT GLUCOSE REAGENT TEST
K884756 · Heraeus Kulzer, Inc. · Jan 1989
GLUCOSE LIQUID AMRESCO #4628300 & 4628001L
K884909 · American Research Products Co. · Jan 1989