ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit— 510(k) K172402

Clearance details

Applicant

Luminex Corporation

Product code

Code PGX

Device class

Class 2

Regulation

21 CFR 866.2680

Advisory panel

Microbiology

Date received

2017-08-09

Decision date

2017-10-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Austin, TX, US

• K260047 — cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190) +1 more2026-08-28
• K260333 — LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit2026-06-15
• K201269 — Accula Strep A Test2020-11-09
• K183366 — GenePOC Strep A2019-03-06
• K173653 — Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit2018-05-02

• K253722 — LIAISON PLEX Gastrointestinal Flex Assay2026-05-19
• 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

• Z-2286-2019 — ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469Class II·Ongoing·Luminex Corporation·20190220

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172402.