Cleared Traditional

K931188 - CHECKMATE PLUS BLOOD GLUCOSE METER, TEST STRIP,ETC

K931188 is an FDA 510(k) clearance for CHECKMATE PLUS BLOOD GLUCOSE METER, manufactured by Cascade Medical, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K931188 · Cascade Medical, Inc. · Chemistry device
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May 1993
Decision
78d
Days
Class 2
Risk

K931188 is an FDA 510(k) clearance for the CHECKMATE PLUS BLOOD GLUCOSE METER, TEST STRIP,ETC. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Cascade Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on May 26, 1993 after a review of 78 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 Cascade Medical, Inc. devices

FDA 510(k) Submission Details - K931188

510(k) Number K931188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1993
Decision Date May 26, 1993
Days to Decision 78 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 88d · This submission: 78d
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 313
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K931188.
ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP
K922136 · Home Diagnostics, Inc. · Aug 1993
DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP
K922137 · Home Diagnostics, Inc. · Aug 1993
GLUCOMETER M+ BLOOD GLUCOSE METER
K931310 · Heraeus Kulzer, Inc. · Jun 1993
HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807
K925551 · Hichem Diagnostics · Apr 1993
GLUCOSE TEST SYSTEM
K923587 · Polymer Technology Corp. · Dec 1992
UNI-CHECK REAGENT STRIP
K924398 · Diagnostic Solutions, Inc. · Dec 1992