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510(k) K251085

iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro by Ihealth Labs, Inc. — Product Code SCA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2025
Date Received
April 9, 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.

Other clearances by Ihealth Labs, Inc.

  • K251092 — iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro (December 12, 2025)
  • K243146 — iCare APP (February 3, 2025)
  • K233842 — iHealth COVID-19 Antigen Rapid Test (May 31, 2024)

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)
  • K251538 — Status™ COVID-19/Flu A&B (November 14, 2025)
  • K251749 — Flowflex Plus RSV + Flu A/B + COVID Home Test (October 22, 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)