Cleared Traditional

K943503 - CHEMCARD GLUCOSE TEST

K943503 is an FDA 510(k) clearance for CHEMCARD GLUCOSE TEST, manufactured by Chem-Elec, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K943503

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
Combination Product No
PCCP Authorized No
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.

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 312
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K943503.
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SELFCARE BLOOD GLUCOSE TEST STRIPS FOR THE EXACTECH SYSTEM
K960053 · Selfcare, Inc. · Jun 1996
EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM
K961337 · Medisense, Inc. · Jun 1996