Cleared Traditional

K072135 - KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT (FDA 510(k) Clearance)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K072135 · Kronus Market Development Associates, Inc. · Immunology device
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Nov 2007
Decision
97d
Days
Class 2
Risk

K072135 is an FDA 510(k) clearance for the KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT. Classified as Autoantibodies, Glutamic Acid Decarboxylase (gad) (product code NWG), Class II - Special Controls.

Submitted by Kronus Market Development Associates, Inc. (Boise, US). The FDA issued a Cleared decision on November 7, 2007 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - the FDA immunology device 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Kronus Market Development Associates, Inc. devices

Submission Details

510(k) Number K072135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2007
Decision Date November 07, 2007
Days to Decision 97 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 104d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NWG Autoantibodies, Glutamic Acid Decarboxylase (gad)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
Definition The Device Is Used For The Semi-quantitative Determination Of Glutamic Acid Decarboxylase (gad) Autoantibodies In Human Serum As An Aid In The Diagnosis Of Type I Diabetes Mellitus (autoimmune Mediated Diabetes).
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 Immunology devices follow this clearance model.