Cleared Traditional

K891050 - STAT CHEM SYSTEM

K891050 is the FDA 510(k) clearance for STAT CHEM SYSTEM by Diagnostic Resources, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K891050 · Diagnostic Resources, Inc. · Chemistry device
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Jul 1989
Decision
142d
Days
Class 2
Risk

K891050 is an FDA 510(k) clearance for the STAT CHEM SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Diagnostic Resources, Inc. (Bohemia, US). The FDA issued a Cleared decision on July 20, 1989 after a review of 142 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 Diagnostic Resources, Inc. devices

Submission Details

510(k) Number K891050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1989
Decision Date July 20, 1989
Days to Decision 142 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 88d · This submission: 142d
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 198
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K891050.
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
GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST
K893117 · Bayer Corp. · Jun 1989
NEOCHROME(R) III GLUCOSE
K892002 · American Monitor Corp. · Jun 1989
GLUCOFILM TEST STRIPS & CONTROLS/GLUCOMETER 3
K890873 · Heraeus Kulzer, Inc. · Apr 1989