LIAISON PLEX Gastrointestinal Flex Assay— 510(k) K253722

Name: FDA 510(k) clearance K253722
Creator: U.S. Food and Drug Administration
Published: 2026-05-19

Substantially Equivalent

Luminex Corporation

FDA 510(k) clearance K253722 for LIAISON PLEX Gastrointestinal Flex Assay, Substantially Equivalent on 2026-05-19. Applicant: Luminex Corporation. Device class: 2.

Summary

Luminex's LIAISON PLEX Gastrointestinal Flex Assay is filed under PCH, gastrointestinal pathogen panel multiplex nucleic acid-based assay systems.

Class II, 21 CFR 866.3990. Microbiology is both the classification panel and the review panel, and the submission was a Traditional 510(k).

Luminex filed from Northbrook, Illinois. Review took 176 calendar days (November 24, 2025 to May 19, 2026).

Clearance details

Applicant: Luminex Corporation
Product code: Product code PCH
Device class: Class 2
Regulation: 21 CFR 866.3990
Advisory panel: Microbiology
Date received: 2025-11-24
Decision date: 2026-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northbrook, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PCH

view all

K254032 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V2026-03-09
K251721 — Xpert GI Panel2026-01-16
K252329 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V2025-10-22
K251868 — Panther Fusion GI Bacterial Assay2025-09-25
K251993 — Panther Fusion GI Expanded Bacterial Assay2025-09-25

More clearances from Luminex Corporation

view all

K243490 — LIAISON PLEX Gram-Positive Blood Culture Assay2025-06-06
K243013 — LIAISON PLEX Gram-Negative Blood Culture Assay2025-04-18
K240627 — LIAISON PLEX Yeast Blood Culture Assay2024-06-04
K233410 — LIAISON PLEX Respiratory Flex Assay2024-03-01
K191742 — ARIES MRSA Assay2019-09-25

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