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Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours

The Tracker / September 2026 / K254262

510(k) cleared

Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA

Ortho Clinical Diagnostics Inc. (QuidelOrtho) · Sep 4, 2026 · K254262

FDA cleared the Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA from Ortho Clinical Diagnostics Inc. (QuidelOrtho) on Sep 4, 2026 under K254262, a dual track 510(k). The device falls under product code PSZ, Devices Detecting Influenza A, B, And C Virus Antigens, regulated at 21 CFR 866.3328 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Dec 30, 2025. The decision came 248 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Ortho Clinical Diagnostics Inc. (QuidelOrtho) has 3 other decisions in the tracker over the last 12 months: K254264 (Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA), K254295 (Sofia Lyme FIA; Sofia 2 Campylobacter FIA), K252393 (VITROS Immunodiagnostic Products hs Troponin I Reagent Pack).

Questions & Answers

What did FDA clear under K254262?

K254262 is the FDA 510(k) for Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA, submitted by Ortho Clinical Diagnostics Inc. (QuidelOrtho). FDA's decision date was Sep 4, 2026, under product code PSZ (Devices Detecting Influenza A, B, And C Virus Antigens).

Who makes the Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA?

Ortho Clinical Diagnostics Inc. (QuidelOrtho), based in San Diego, CA, is the applicant of record for K254262.

How long did the K254262 review take?

FDA received the submission on Dec 30, 2025 and issued its decision on Sep 4, 2026, 248 days later.

← All decisions in September 2026

Sources