510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K251085Substantially Equivalent

iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro

iHealth Labs, Inc., Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K251085 is the FDA 510(k) clearance record for iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro, a class II device, cleared for Ihealth Labs, Inc. on under FDA product code SCA (Multi-Analyte Respiratory Virus Antigen Detection Test). FDA's definition for product code SCA reads: "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...". FDA records list 4 510(k) clearances for Ihealth Labs, Inc., from to . As of , FDA records show no recalls naming K251085.

Clearance record

Decision date
Received
(247 days to decision)
Product code
SCA Multi-Analyte Respiratory Virus Antigen Detection Test
Regulation
21 CFR 866.3987
Device class
Class II
Review panel
Microbiology
Applicant
Ihealth Labs, Inc. 880 W Maude Ave.,, Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SCA

Trailing 12 months
4 clearances under product code SCA in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code SCA, trailing twelve months
MonthClearances
November 20251
December 20252
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260