Not Cleared Post-NSE

DEN140004 - QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY

DEN140004 is an FDA 510(k) submission for QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ..., manufactured by Diagnostic Hybrids, Inc.. The device is a Class 2 Microbiology device with product code PGI cleared through the Post-NSE 510(k) pathway after a 81-day FDA review.

DEN140004 · Diagnostic Hybrids, Inc. · Microbiology device
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May 2014
Decision
81d
Days
Class 2
Risk

DEN140004 is an FDA 510(k) submission (not cleared) for the QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY. Classified as Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples (product code PGI), Class II - Special Controls.

Submitted by Diagnostic Hybrids, Inc. (Athens, US). The FDA issued a Not Cleared (DENG) decision on May 13, 2014 after a review of 81 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3309 - 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.

FDA 510(k) Submission Details - DEN140004

510(k) Number DEN140004 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 21, 2014
Decision Date May 13, 2014
Days to Decision 81 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
21d faster than avg
Panel avg: 102d · This submission: 81d
Pathway characteristics

PGI Device Classification - Class 2, Special Controls

Product Code PGI Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3309
Definition For The Qualitative Detection And Differentiation Of Vzv, Hsv1, Hsv2- Dna In Cutaneous And Mucocutaneous Lesion Samples From Symptomatic Patients. The Assay Is Not Intended For Use With Cerebral Spinal Fluid.
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.

Regulatory Peers - PGI Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples

All 8
Devices cleared under the same product code (PGI) and FDA review panel - the closest regulatory comparables to DEN140004.
Solana HSV 1+2/VZV Assay
K162451 · Quidel Corporation · Nov 2016
ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD)
K151906 · Luminex Corporation · Oct 2015
illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10
K151046 · Meridian Bioscience, Inc. · Jul 2015
DEN140004 · QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY
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