Cleared Traditional

K013342 - EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC.

K013342 is an FDA 510(k) clearance for EXCELSIOR TEST STRIPS, manufactured by Chay Medical, LLC. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K013342 · Chay Medical, LLC · Chemistry device
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Feb 2002
Decision
129d
Days
Class 2
Risk

K013342 is an FDA 510(k) clearance for the EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC.. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Chay Medical, LLC (Calistoga, US). The FDA issued a Cleared decision on February 15, 2002 after a review of 129 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K013342

510(k) Number K013342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2001
Decision Date February 15, 2002
Days to Decision 129 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
40d slower than avg
Panel avg: 89d · This submission: 129d
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 399
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K011479 · Inverness Medical Innovations, Inc. · Nov 2001
K013342 · EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC.
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