510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K232643Substantially Equivalent

Cue COVID-19 Molecular Test

Cue Health, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K232643 is the FDA 510(k) clearance record for Cue COVID-19 Molecular Test, a class II device, cleared for Cue Health, Inc. on under FDA product code QWB (Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens). FDA's definition for product code QWB reads: "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...". FDA records list 2 510(k) clearances for Cue Health, Inc., from to . As of , FDA records show no recalls naming K232643.

Clearance record

Decision date
Received
(90 days to decision)
Product code
QWB Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
Regulation
21 CFR 866.3984
Device class
Class II
Review panel
Microbiology
Applicant
Cue Health, Inc. 4980 Carroll Canyon Rd., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QWB

Trailing 12 months
1 clearance under product code QWB in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QWB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260