Not Cleared Post-NSE

DEN120001 - IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE

DEN120001 is an FDA 510(k) submission for IMMUNOCAP TRYPTASE, manufactured by Phadia US, Inc.. The device is a Class 2 Immunology device with product code OYL cleared through the Post-NSE 510(k) pathway after a 34-day FDA review.

DEN120001 · Phadia US, Inc. · Immunology device
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Feb 2012
Decision
34d
Days
Class 2
Risk

DEN120001 is an FDA 510(k) submission (not cleared) for the IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRI.... Classified as Tryptase Assay System (product code OYL), Class II - Special Controls.

Submitted by Phadia US, Inc. (Portage, US). The FDA issued a Not Cleared (DENG) decision on February 15, 2012 after a review of 34 days.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5760 - 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 - DEN120001

510(k) Number DEN120001 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 12, 2012
Decision Date February 15, 2012
Days to Decision 34 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
71d faster than avg
Panel avg: 105d · This submission: 34d
Pathway characteristics

OYL Device Classification - Class 2, Special Controls

Product Code OYL Tryptase Assay System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5760
Definition An In Vitro Diagnostic Device Intended As An Aid In The Clinical Diagnosis Of Patients With A Suspicion Of Systemic Mastocytosis 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.

DEN120001 · IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE
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