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510(k) K243490

LIAISON PLEX Gram-Positive Blood Culture Assay by Luminex Corporation — Product Code PAM

K243490 is an FDA 510(k) premarket notification submitted by Luminex Corporation for the device "LIAISON PLEX Gram-Positive Blood Culture Assay". The FDA issued a decision of Substantially Equivalent on June 6, 2025. The device falls under product code PAM (Gram-Positive Bacteria And Their Resistance Markers), a Class II device regulated under 21 CFR 866.3365. Luminex Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2025
Date Received
November 12, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gram-Positive Bacteria And Their Resistance Markers
Device Class
Class II
Regulation Number
866.3365
Review Panel
MI
Submission Type

A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.

Other clearances by Luminex Corporation

  • K253722 — LIAISON PLEX Gastrointestinal Flex Assay (May 19, 2026)
  • 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)
  • K172402 — ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit (October 30, 2017)
  • 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 PAM

  • K181663 — ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel (December 20, 2018)
  • K163390 — iC-GPC Assay TM for use on the iC-SystemTM (August 8, 2017)
  • K152470 — Great Basin Staph ID/R Blood Culture Panel (March 25, 2016)
  • K122514 — VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST (September 19, 2012)
  • DEN120014 — VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) (June 26, 2012)

FDA data resources