FINDER Flu A&B/SARS-CoV-2 Test— 510(k) K261837

Name: FDA 510(k) clearance K261837
Creator: U.S. Food and Drug Administration
Published: 2026-09-11

Substantially Equivalent

Baebies, Inc.

FDA 510(k) clearance K261837 for FINDER Flu A&B/SARS-CoV-2 Test, Substantially Equivalent on 2026-09-11. Applicant: Baebies, Inc.. Device class: 2.

Summary

The FINDER Flu A&B/SARS-CoV-2 Test is a multiplex molecular assay under QOF: nucleic acid tests that detect SARS-CoV-2 and other respiratory pathogens from a single specimen. This one looks for influenza A, influenza B, and SARS-CoV-2, and runs on Baebies' FINDER instrument.

Class II, 21 CFR 866.3981. The Microbiology panel reviewed it as a Traditional 510(k). FDA created that regulation for SARS-CoV-2 multiplex assays as they moved off emergency use authorization and onto regular clearances.

Baebies filed from Durham, North Carolina. Review took 101 days (June 2 to September 11, 2026). That's reasonably quick for a respiratory panel, where the clinical performance study is usually what holds things up.

Clearance details

Applicant: Baebies, Inc.
Product code: Code QOF
Device class: Class 2
Regulation: 21 CFR 866.3981
Advisory panel: Microbiology
Date received: 2026-06-02
Decision date: 2026-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QOF

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K252932 — Fast PCR Mini Respiratory Panel2026-06-12
K252269 — FINDER Flu A&B/SARS-CoV-2 Test2026-03-30
K251742 — VELO Respiratory Test2026-02-13
K251978 — LIAISON NES FLU A/B, RSV & COVID-192025-12-23
K252387 — Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)2025-10-30

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K201049 — FINDER G6PD2022-09-14
DEN150035 — SEEKER System2017-02-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.