Alinity m STI Assay— 510(k) K222379

Substantially Equivalent

Abbott Molecular, Inc.

FDA 510(k) clearance K222379 for Alinity m STI Assay, Substantially Equivalent on 2023-03-03. Applicant: Abbott Molecular, Inc.. Device class: 2.

Clearance details

Applicant: Abbott Molecular, Inc.
Product code: Code QEP
Device class: Class 2
Regulation: 21 CFR 866.3393
Advisory panel: Microbiology
Date received: 2022-08-05
Decision date: 2023-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Abbott Molecular, Inc.

K252102 — Alinity m HCV2025-09-25
K243489 — Alinity m EBV (09N43-095)2025-07-28
K243485 — Alinity m CMV2025-07-01
K241921 — Alinity m BKV2025-03-24
K241573 — Alinity m Resp-4-Plex2025-02-14

Recalls naming K222379

K-number listed on FDA's recall record

Z-0234-2025 — Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091;Class II·Ongoing·Abbott Molecular, Inc.·20240912

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K222379.

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