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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / November 2025 / K251697

510(k) cleared

Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip

ACON Laboratories, Inc. · Nov 26, 2025 · K251697

FDA cleared the Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip from ACON Laboratories, Inc. on Nov 26, 2025 under K251697, a dual track 510(k). The device falls under product code GTY, Antigens, All Groups, Streptococcus Spp., regulated at 21 CFR 866.3740 as a Class 1 device. The review panel was Microbiology.

FDA logged the submission as received on Jun 2, 2025. The decision came 177 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

ACON Laboratories, Inc. has 3 other decisions in the tracker over the last 12 months: K261212 (Flowflex Plus RSV + Flu A/B + COVID Rapid Test), K251749 (Flowflex Plus RSV + Flu A/B + COVID Home Test), K250085 (On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System).

Questions & Answers

What did FDA clear under K251697?

K251697 is the FDA 510(k) for Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip, submitted by ACON Laboratories, Inc.. FDA's decision date was Nov 26, 2025, under product code GTY (Antigens, All Groups, Streptococcus Spp.).

Who makes the Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip?

ACON Laboratories, Inc., based in San Diego, CA, is the applicant of record for K251697.

How long did the K251697 review take?

FDA received the submission on Jun 2, 2025 and issued its decision on Nov 26, 2025, 177 days later.

← All decisions in November 2025

Sources