Cleared Traditional

K980573 - SENSOREX BLOOD GLUCOSE MONITORING SYSTEM

K980573 is an FDA 510(k) clearance for SENSOREX BLOOD GLUCOSE MONITORING SYSTEM, manufactured by Chronimed, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K980573 · Chronimed, Inc. · Chemistry device
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Jul 1998
Decision
163d
Days
Class 2
Risk

K980573 is an FDA 510(k) clearance for the SENSOREX BLOOD GLUCOSE MONITORING SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Chronimed, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on July 30, 1998 after a review of 163 days - an extended review 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: 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 Chronimed, Inc. devices

FDA 510(k) Submission Details - K980573

510(k) Number K980573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1998
Decision Date July 30, 1998
Days to Decision 163 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 88d · This submission: 163d
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 272
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K980573.
GLUCOMETER ELITE XL BLOOD GLUCOSE METER
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PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST
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CARESIDE GLUCOSE
K981183 · Exigent Diagnostics, Inc. · May 1998
ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
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K972669 · Polymer Technology Systems, Inc. · Jan 1998