# K213936: LIAISON MeMed BV, LIAISON MeMed BV Control Set

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Jul 14, 2022 after 210 days
- Product code: QPS (Immunoassay For Host Biomarkers Of Infection)
- Device class: 2
- Regulation: 21 CFR 866.3215
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K071146 (2007). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210254: MeMed BV, MeMed Diagnostics, Ltd. (2021) Summary page 5.

## Indications for use
The DiaSorin LIAISON® MeMed BV@ is an automated in vitro diagnostic semi-quantitative assay that uses chemiluminescent immunoassay (CLIA) technology to measure three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples and is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. The LIAISON@ MeMed BV@ assay is indicated for use in patients presenting to the emergency department or urgent care center and with samples collected at hospital admission from patients with suspected acute bacterial or viral infection, who have had symptoms for seven days or less. The LIAISON@ MeMed BV® assay generates a numeric score that falls within discrete interpretation ranges based on the increasing likelihood of bacterial infection. The assay has to be performed on the automated LIAISON® XL Analyzer. The DiaSorin LIAISON® MeMed BV® Control Set is intended for use as assayed quality control to monitor the performance of the DiaSorin LIAISON® MeMed BV® assay. The performance characteristics of the LIAISON® controls have not been established for any other assays or instrument platforms different from the automated LIAISON® XL Analyzer. The control set is intended for in vitro diagnostic use in a professional laboratory only.

Source page: https://510kreport.com/device/K213936
Methodology: https://510kreport.com/methodology