Cleared Traditional

K895526 - COBAS READY GLUCOSE REAGENT

K895526 is the FDA 510(k) clearance for COBAS READY GLUCOSE REAGENT by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K895526 · Roche Diagnostic Systems, Inc. · Chemistry device
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Oct 1989
Decision
34d
Days
Class 2
Risk

K895526 is an FDA 510(k) clearance for the COBAS READY GLUCOSE REAGENT. 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 October 16, 1989 after a review of 34 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 K895526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1989
Decision Date October 16, 1989
Days to Decision 34 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
54d faster than avg
Panel avg: 88d · This submission: 34d
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 K895526.
SYNERMED GLUCOSE REAGENT KIT
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K895911 · Lifescan, Inc. · Nov 1989
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K893117 · Bayer Corp. · Jun 1989
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K892002 · American Monitor Corp. · Jun 1989
GLUCOFILM TEST STRIPS & CONTROLS/GLUCOMETER 3
K890873 · Heraeus Kulzer, Inc. · Apr 1989