Not Cleared Post-NSE

DEN140001 - ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT

DEN140001 is an FDA 510(k) submission for ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ..., manufactured by Kronus Market Development Associates, Inc.. The device is a Class 2 Immunology device with product code PHF cleared through the Post-NSE 510(k) pathway after a 65-day FDA review.

DEN140001 · Kronus Market Development Associates, Inc. · Immunology device
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Aug 2014
Decision
65d
Days
Class 2
Risk

DEN140001 is an FDA 510(k) submission (not cleared) for the ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT. Classified as Zinc Transporter 8 Auto-antibody (product code PHF), Class II - Special Controls.

Submitted by Kronus Market Development Associates, Inc. (Star, US). The FDA issued a Not Cleared (DENG) decision on August 20, 2014 after a review of 65 days.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5670 - the FDA immunology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Immunology review framework.

FDA 510(k) Submission Details - DEN140001

510(k) Number DEN140001 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 16, 2014
Decision Date August 20, 2014
Days to Decision 65 days
Submission Type Post-NSE
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 105d · This submission: 65d
Pathway characteristics

PHF Device Classification - Class 2, Special Controls

Product Code PHF Zinc Transporter 8 Auto-antibody
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5670
Definition The Zinc Transporter 8 Autoantibody (znt8ab) Elisa Assay Is For The Semi-quantitative Determination Of Autoantibodies To Zinc Transporter 8 (znt8) In Human Serum. The Zinc Transporter 8 Autoantibody (znt8ab) Elisa Assay May Be Useful As An Aid In The Diagnosis Of Type 1 Diabetes Mellitus (autoimmune Mediated Diabetes). The Znt8ab Assay Is Not To Be Used Alone And Is To Be Used In Conjunction With Other Clinical And Laboratory Findings.
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.

DEN140001 · ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT
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