510(k) · Cleared
ClearedLIAISON MeMed BV, LIAISON MeMed BV Control Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · QPS Immunoassay For Host Biomarkers Of Infection
Cleared on Jul 14, 2022 as substantially equivalent to K210254 (MeMed Diagnostics, Ltd., 2021) after a 210-day review. Its family tree reaches back 4 generations to 2007.
- Decided
- Jul 14, 2022
- Review
- 210 days
- Class
- Class II
- Product code
- QPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K071146 (2007). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK071146 Vidas B.R.a.H.M.S. PCT AssaybioMerieux, Inc. · 2007 · Recalled
- 3 generations backK160911 Vidas B.R.a.H.M.S. PCT (PCT)bioMerieux, Inc. · 2016
- 2 generations backK162827 Vidas B.R.a.H.M.S. PCT (PCT)bioMerieux, Inc. · 2017
- 1 generation backK210254 MeMed BVMeMed Diagnostics, Ltd. · 2021
- This deviceK213936 LIAISON MeMed BV, LIAISON MeMed BV Control SetDiaSorin, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K071146 | Vidas B.R.a.H.M.S. PCT Assay | bioMerieux, Inc. | 2007 | 1 |
| −3 | K160911 | Vidas B.R.a.H.M.S. PCT (PCT) | bioMerieux, Inc. | 2016 | — |
| −2 | K162827 | Vidas B.R.a.H.M.S. PCT (PCT) | bioMerieux, Inc. | 2017 | — |
| −1 | K210254 | MeMed BV | MeMed Diagnostics, Ltd. | 2021 | — |
| 0 (this device) | K213936 | LIAISON MeMed BV, LIAISON MeMed BV Control Set | DiaSorin, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QPS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QPS device
- #1 K222332 MeMed BVscore 8.9 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K210254 | MeMed BVSummary page 5…AISON® MeMed BV® is substantially equivalent in principle and performance to the MeMed Diagnostics Ltd. MeMed BV® assay which was FDA cleared on September 01, 2021- 510k K210254. Section 5 Page 5 - 2… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 1 other device also cites its predicate K210254.
How does its category compare?
All QPS devicesQPS Immunoassay For Host Biomarkers Of Infection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QPS
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QPS
Too few QPS 510(k)s in any year since 2007 to give a median.
Recalls per year · QPS
No recall names QPS since 2007.
Adverse event reports per year · QPS
No MAUDE report names QPS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (204 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213936 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213936: LIAISON MeMed BV, LIAISON MeMed BV Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213936
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026