Cleared Traditional

K232643 - Cue COVID-19 Molecular Test (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232643 · Cue Health, Inc. · Microbiology device
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Nov 2023
Decision
90d
Days
Class 2
Risk

K232643 is an FDA 510(k) clearance 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 Cleared decision on November 28, 2023 after a review of 90 days - within the typical 510(k) review window.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cue Health, Inc. devices

Submission Details

510(k) Number K232643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2023
Decision Date November 28, 2023
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.