Cleared Traditional

K943503 - CHEMCARD GLUCOSE TEST

K943503 is the FDA 510(k) clearance for CHEMCARD GLUCOSE TEST by Chem-Elec, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 734-day FDA review.

K943503 · Chem-Elec, Inc. · Chemistry device
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Jul 1996
Decision
734d
Days
Class 2
Risk

K943503 is an FDA 510(k) clearance for the CHEMCARD GLUCOSE TEST. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Chem-Elec, Inc. (North Webster, US). The FDA issued a Cleared decision on July 23, 1996 after a review of 734 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Chem-Elec, Inc. devices

Submission Details

510(k) Number K943503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1994
Decision Date July 23, 1996
Days to Decision 734 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
646d slower than avg
Panel avg: 88d · This submission: 734d
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 K943503.
GLUCOMETER ELITE BLOOD GLUCOSE METER
K964630 · Bayer Corp. · Feb 1997
GLUCOMETER DEX DIABETES CARE SYSTEM
K963500 · Bayer Corp. · Jan 1997
SIGMA DIAGNOSTICS GLUCOSE REAGENT
K963535 · Sigma Diagnostics, Inc. · Jan 1997
EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU)
K955286 · Johnson & Johnson Clinical Diagnostics, Inc. · May 1996
ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM
K944459 · Boehringer Mannheim Corp. · Apr 1996
ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS
K952875 · Boehringer Mannheim Corp. · Nov 1995