Cleared Traditional

K893117 - GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFI...

K893117 is the FDA 510(k) clearance for GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFI... by Bayer Corp.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K893117 · Bayer Corp. · Chemistry device
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Jun 1989
Decision
52d
Days
Class 2
Risk

K893117 is an FDA 510(k) clearance for the GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Bayer Corp. (Elkhart, US). The FDA issued a Cleared decision on June 16, 1989 after a review of 52 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 Bayer Corp. devices

Submission Details

510(k) Number K893117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1989
Decision Date June 16, 1989
Days to Decision 52 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
36d faster than avg
Panel avg: 88d · This submission: 52d
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 190
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K893117.
GLUCOMETER GX BLOOD GLUCOSE METER
K897015 · Heraeus Kulzer, Inc. · Mar 1990
ONE TOUCH II METER
K895911 · Lifescan, Inc. · Nov 1989
COBAS READY GLUCOSE REAGENT
K895526 · Roche Diagnostic Systems, Inc. · Oct 1989
NEOCHROME(R) III GLUCOSE
K892002 · American Monitor Corp. · Jun 1989
GLUCOFILM TEST STRIPS & CONTROLS/GLUCOMETER 3
K890873 · Heraeus Kulzer, Inc. · Apr 1989
ROCHE CHLORIDE ELECTRODE
K890528 · Roche Diagnostic Systems, Inc. · Mar 1989