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510(k) K172402

ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit by Luminex Corporation — Product Code PGX

K172402 is an FDA 510(k) premarket notification submitted by Luminex Corporation for the device "ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit". The FDA issued a decision of Substantially Equivalent on October 30, 2017. The device falls under product code PGX (Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System), a Class II device regulated under 21 CFR 866.2680. Luminex Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2017
Date Received
August 9, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Device Class
Class II
Regulation Number
866.2680
Review Panel
MI
Submission Type

An in vitro diagnostic test for the detection of Group A, C and G beta hemolytic Streptococcus in throat swab specimens from symptomatic patients.

Other clearances by Luminex Corporation

  • K253722 — LIAISON PLEX Gastrointestinal Flex Assay (May 19, 2026)
  • K243490 — LIAISON PLEX Gram-Positive Blood Culture Assay (June 6, 2025)
  • K243013 — LIAISON PLEX Gram-Negative Blood Culture Assay (April 18, 2025)
  • K240627 — LIAISON PLEX Yeast Blood Culture Assay (June 4, 2024)
  • K233410 — LIAISON PLEX Respiratory Flex Assay (March 1, 2024)
  • K191742 — ARIES MRSA Assay (September 25, 2019)
  • K171441 — ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Ki (July 21, 2017)
  • K163626 — ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit (May 2, 2017)
  • K162772 — ARIES GBS Assay (December 23, 2016)
  • K161220 — ARIES® Flu A/B & RSV Assay (August 2, 2016)

Other clearances for product code PGX

  • K260333 — LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit (June 15, 2026)
  • K201269 — Accula Strep A Test (November 9, 2020)
  • K183366 — GenePOC Strep A (March 6, 2019)
  • K173653 — Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit (May 2, 2018)
  • K173398 — Xpert Xpress Strep A (April 26, 2018)
  • K172126 — Xpert Xpress Strep A (September 25, 2017)
  • K162274 — Solana Strep Complete Assay (October 25, 2016)
  • K150868 — Solana GAS Assay, Solana instrument (June 23, 2015)
  • K141757 — ALERE I STREP A (March 31, 2015)
  • K143651 — Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack (March 18, 2015)

FDA data resources