510(k) K251749

Flowflex Plus RSV + Flu A/B + COVID Home Test by ACON Laboratories, Inc. — Product Code SCA

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 22, 2025
Date Received: June 6, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Multi-Analyte Respiratory Virus Antigen Detection Test
Device Class: Class II
Regulation Number: 866.3987
Review Panel: MI
Submission Type

A multi-analyte respiratory virus antigen detection test is an in vitro diagnostic device intended for the detection and/or differentiation of respiratory viruses directly from respiratory clinical specimens. The device is intended to be performed at the site of sample collection, does not involve sample storage and/or transport.

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K232715 — Distinct® Digital Pregnancy Test (May 31, 2024)
K233373 — Flowflex® Plus COVID-19 Home Test (April 19, 2024)
K230828 — Flowflex COVID-19 Antigen Home Test (November 9, 2023)
K193318 — Distinct® Early Detection Pregnancy Test (August 20, 2020)
K192175 — On Call Express II Blood Glucose Monitoring System (October 17, 2019)
K191038 — On Call Express Voice Blood Glucose Monitoring System (June 12, 2019)
K181527 — On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Mo (October 3, 2018)

Other clearances for product code SCA

K251092 — iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro (December 12, 2025)
K251085 — iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test (December 12, 2025)
K251538 — Status COVID-19/Flu A&B (November 14, 2025)
K251604 — CareSuperb COVID-19/Flu A&B Antigen Combo Home Test (August 22, 2025)
K251563 — WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test (August 20, 2025)
K243561 — Nano-Check Influenza+COVID-19 Dual Test (June 17, 2025)
K250377 — Flowflex Plus COVID-19 + Flu A/B Home Test (May 10, 2025)
K243256 — WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B (January 16, 2025)
K243262 — QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pr (January 13, 2025)
DEN240029 — Healgen Rapid Check COVID-19/Flu A&B Antigen Test (October 7, 2024)