Baebies FINDER Platform Achieves Dual 510(k) Clearance and CLIA-Waiver for Flu/COVID-19 Test, Breaking PCR-Only Barrier

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The FDA granted 510(k) clearance and CLIA-waiver to Baebies' FINDER Flu A&B/SARS-CoV-2 Test, making FINDER the first molecular point-of-care platform with multifunctional capabilities beyond PCR-only tests.1

The FINDER platform delivers positive results in as little as 15 minutes and negative results in about 20 minutes, using digital microfluidics with integrated sample preparation in an enclosed cartridge.1

Designed for decentralized settings like urgent care, emergency departments, and clinics, it supports single-visit diagnostic decisions with minimal hands-on time.1

Previously, FINDER received 510(k) clearance for a G6PD test and Breakthrough Device Designation for an Anti-Factor Xa Test for heparin monitoring.1

Baebies is developing additional assays including high-plex panels for pathogens from various samples, host-response tests, and qPCR for HIV and HCV.1

Sources:

1. https://clpmag.com/disease-states/infectious-diseases/flu-respiratory-infections/fda-clears-rapid-molecular-poc-test-flu-covid19/