LIAISON PLEX Gram-Positive Blood Culture Assay
FDA 510(k) K243490 · Luminex Corporation
510(k) numberK243490
Submission
- Device name
- LIAISON PLEX Gram-Positive Blood Culture Assay
- Applicant
- Luminex Corporation
Northbrook, IL, US - Received
- November 12, 2024
- Decision date
- June 6, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PAM – Gram-Positive Bacteria And Their Resistance Markers
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3365
- Specialty
- Microbiology
A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.
Other 510(k)s with product code PAM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254194 | QIAstat-Dx BCID GPF Plus AMR PanelPAM · Traditional | QIAGEN GmbH | 08/06/2026SE |
| K181663 | ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) PanelPAM · Traditional | Genmark Diagnostics, Incorporated | 12/20/2018SE |
| K163390 | iC-GPC Assay TM for use on the iC-SystemTMPAM · Traditional | Icubate, Inc. | 08/08/2017SE |
| K152470 | Great Basin Staph ID/R Blood Culture PanelPAM · Traditional | Great Basin Scientific, Inc. | 03/25/2016SE |
| K122514 | Verigene Gram-Positive Blood Culture (Gc-Gp) Nucleic Acid TestPAM · Traditional | Nanosphere, Inc. | 09/19/2012SE |
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| K253722 | LIAISON PLEX Gastrointestinal Flex AssayPCH · Traditional | 05/19/2026SE |
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Questions and answers
When was LIAISON PLEX Gram-Positive Blood Culture Assay cleared by the FDA?
LIAISON PLEX Gram-Positive Blood Culture Assay (K243490) received a 510(k) decision of Substantially Equivalent on June 6, 2025, 206 days after the submission was received.
What is the product code of K243490?
The FDA product code is PAM – Gram-Positive Bacteria And Their Resistance Markers, a Class II (moderate risk) device regulated under 21 CFR 866.3365.