Not Cleared Direct

DEN190031 - NP Screen (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN190031 · Advance Sentry Corporation · Microbiology device
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May 2020
Decision
322d
Days
Class 2
Risk

DEN190031 is an FDA 510(k) submission (not cleared) for the NP Screen. Classified as Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers (product code OJY), Class II - Special Controls.

Submitted by Advance Sentry Corporation (Markham, CA). The FDA issued a Not Cleared (DENG) decision on May 11, 2020 after a review of 322 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3236 - 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: Regulatory edge-case submission. High predicate equivalence gap. With 322 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

510(k) Number DEN190031 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 24, 2019
Decision Date May 11, 2020
Days to Decision 322 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
220d slower than avg
Panel avg: 102d · This submission: 322d
Pathway characteristics

Device Classification

Product Code OJY Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3236
Definition A Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers Is An In Vitro Diagnostic Test For Prescription Use In The Detection Of Viral Nucleic Acid In Nasopharyngeal Or Oropharyngeal Cellular Specimens From Patients With Signs And Symptoms Of Head And Neck Cancer. The Test Result Is Intended To Be Used In Conjunction With Other Clinical Information To Aid In Assessing The Clinical Status Of Virus-associated Head And Neck Cancers And/or The Likelihood That Head And Neck Cancer Is Present.
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.