Cleared Traditional

K072135 - KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT

K072135 is an FDA 510(k) clearance for KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT, manufactured by Kronus Market Development Associates, Inc.. The device is a Class 2 Immunology device with product code NWG cleared through the Traditional 510(k) pathway after a 97-day FDA review.

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

FDA 510(k) Submission Details - K072135

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 105d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NWG Device Classification - Class 2, Special Controls

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.