Cleared Traditional

K880585 - DEXPAD, BLOOD GLUCOSE STRIP

K880585 is an FDA 510(k) clearance for DEXPAD, manufactured by Mach Diag. C/O Wichita State University. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K880585 · Mach Diag. C/O Wichita State University · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1988
Decision
68d
Days
Class 2
Risk

K880585 is an FDA 510(k) clearance for the DEXPAD, BLOOD GLUCOSE STRIP. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Mach Diag. C/O Wichita State University (Wichita, US). The FDA issued a Cleared decision on April 18, 1988 after a review of 68 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 Mach Diag. C/O Wichita State University devices

FDA 510(k) Submission Details - K880585

510(k) Number K880585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1988
Decision Date April 18, 1988
Days to Decision 68 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 88d · This submission: 68d
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 K880585.
ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM
K883817 · Boehringer Mannheim Corp. · Dec 1988
TRACER(TM) II BLOOD GLUCOSE SYSTEM
K881908 · Boehringer Mannheim Corp. · Jul 1988
GLUCOSE (TRINDER) CAT. # 220-32
K875211 · Diagnostic Chemicals, Ltd. (Usa) · Apr 1988
GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT
K871835 · Miles Laboratories, Inc. · Dec 1987
DIASCAN* BLOOD GLUCOSE SELF-MONITORING TEST STRIPS
K872505 · Home Diagnostics, Inc. · Oct 1987
BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT
K873117 · Biotrol, USA, Inc. · Aug 1987