Not Cleared Post-NSE

DEN140005 - LYRA DIRECT STREP ASSAY

DEN140005 is the FDA 510(k) submission for LYRA DIRECT STREP ASSAY by Quidel Corporation. It is a Class 2 Microbiology device (product code PGX) cleared through the Post-NSE 510(k) pathway after a 22-day FDA review.

DEN140005 · Quidel Corporation · Microbiology device
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Apr 2014
Decision
22d
Days
Class 2
Risk

DEN140005 is an FDA 510(k) submission (not cleared) for the LYRA DIRECT STREP ASSAY. Classified as Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System (product code PGX), Class II - Special Controls.

Submitted by Quidel Corporation (Athens, US). The FDA issued a Not Cleared (DENG) decision on April 16, 2014 after a review of 22 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2680 - the FDA microbiology 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 Microbiology review framework.

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Submission Details

510(k) Number DEN140005 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 25, 2014
Decision Date April 16, 2014
Days to Decision 22 days
Submission Type Post-NSE
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 102d · This submission: 22d
Pathway characteristics

Device Classification

Product Code PGX Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.2680
Definition An In Vitro Diagnostic Test For The Detection Of Group A, C And G Beta Hemolytic Streptococcus In Throat Swab Specimens From Symptomatic Patients.
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 Microbiology devices follow this clearance model.