Not Cleared Direct

DEN220028 - Cue COVID-19 Molecular Test (FDA 510(k) Clearance)

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

DEN220028 · Cue Health, Inc. · Microbiology device
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Jun 2023
Decision
400d
Days
Class 2
Risk

DEN220028 is an FDA 510(k) submission (not cleared) for the Cue COVID-19 Molecular Test. Classified as Over-the-counter Molecular Test To Detect Sars-cov-2 From Clinical Specimens (product code QWB), Class II - Special Controls.

Submitted by Cue Health, Inc. (San Diego, US). The FDA issued a Not Cleared (DENG) decision on June 6, 2023 after a review of 400 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3984 - 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 400 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.

View all Cue Health, Inc. devices

Submission Details

510(k) Number DEN220028 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 02, 2022
Decision Date June 06, 2023
Days to Decision 400 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
298d slower than avg
Panel avg: 102d · This submission: 400d
Pathway characteristics

Device Classification

Product Code QWB Over-the-counter Molecular Test To Detect Sars-cov-2 From Clinical Specimens
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3984
Definition An Over-the-counter Molecular Test To Detect Sars-cov-2 Is An In Vitro Diagnostic Device For The Detection Of Sars-cov-2 In Clinical Specimens To Aid In The Diagnosis Of Sars-cov-2 Infection. The Device Is Intended To Be Used By Lay Users And Without Health Care Provider (hcp) Intervention In Home Settings Or Similar Environments.
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.