Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip— 510(k) K251697

Name: FDA 510(k) clearance K251697
Creator: U.S. Food and Drug Administration
Published: 2025-11-26

Substantially Equivalent

ACON Laboratories, Inc.

FDA 510(k) clearance K251697 for Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip, Substantially Equivalent on 2025-11-26. Applicant: ACON Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: ACON Laboratories, Inc.
Product code: Code GTY
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 2025-06-02
Decision date: 2025-11-26
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GTY

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K260342 — AllTest Strep A Rapid Test2026-04-30
K212623 — Healgen Strep A Rapid Test Strip (Throat Swab)2022-03-16
K171976 — Sofia Strep A+ FIA, Sofia 2 Analyzer2017-12-21
K141775 — SOFIA (R) STREP A+ FIA2014-12-16
K133343 — WONDFO RAPID STREP A TEST2014-01-31

More clearances from ACON Laboratories, Inc.

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K261212 — Flowflex Plus RSV + Flu A/B + COVID Rapid Test2026-07-10
K251749 — Flowflex Plus RSV + Flu A/B + COVID Home Test2025-10-22
K250085 — On Call® Sure GK Blood Glucose & Ketone Monitoring System +1 more2025-10-10
K250377 — Flowflex Plus COVID-19 + Flu A/B Home Test2025-05-10
K232715 — Distinct® Digital Pregnancy Test2024-05-31

Adverse events under product code GTY

product code GTY

Death: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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