510(k) · Cleared
ClearedMeMed BV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MeMed Diagnostics, Ltd. · QPS Immunoassay For Host Biomarkers Of Infection
Cleared on Sep 1, 2021 as substantially equivalent to K162827 (bioMerieux, Inc., 2017) after a 215-day review. Its family tree reaches back 3 generations to 2007. 3 later devices descend from it.
- Decided
- Sep 1, 2021
- Review
- 215 days
- Class
- Class II
- Product code
- QPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K071146 (2007). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK071146 Vidas B.R.a.H.M.S. PCT AssaybioMerieux, Inc. · 2007 · Recalled
- 2 generations backK160911 Vidas B.R.a.H.M.S. PCT (PCT)bioMerieux, Inc. · 2016
- 1 generation backK162827 Vidas B.R.a.H.M.S. PCT (PCT)bioMerieux, Inc. · 2017
- This deviceK210254 MeMed BVMeMed Diagnostics, Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK222332 MeMed BVMeMed Diagnostics, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK230944 MeMed BVMeMed Diagnostics, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK213936 LIAISON MeMed BV, LIAISON MeMed BV Control SetDiaSorin, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K071146 | Vidas B.R.a.H.M.S. PCT Assay | bioMerieux, Inc. | 2007 | 1 |
| −2 | K160911 | Vidas B.R.a.H.M.S. PCT (PCT) | bioMerieux, Inc. | 2016 | — |
| −1 | K162827 | Vidas B.R.a.H.M.S. PCT (PCT) | bioMerieux, Inc. | 2017 | — |
| 0 (this device) | K210254 | MeMed BV | MeMed Diagnostics, Ltd. | 2021 | — |
| +1 | K222332 | MeMed BV | MeMed Diagnostics, Ltd. | 2023 | — |
| +2 | K230944 | MeMed BV | MeMed Diagnostics, Ltd. | 2023 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K162827 | Vidas B.R.a.H.M.S. PCT (PCT)Summary page 4…Immunoassay for host biomarkers of infection Regulatory Class: Class II Product Code: QPS Predicate Devices BioMerieux, Inc, VIDAS B.R.A.H.M.S. PCT (PCT) (K162827) Device Description The MeMed BV™ (“BV test” or the “test”) is an In-Vitro-Diagnostic device that measures in… | 2017 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 2 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K222332 (MeMed Diagnostics, Ltd., 2023) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K162827.
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. 2021, 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 MeMed BV test is an automated semi-quantitative immunoassay that measures 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. MeMed BV is indicated for use in patients presenting to the emergency department or urgent care center and with samples collected…
Read the full statement (112 words)
The MeMed BV test is an automated semi-quantitative immunoassay that measures 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. MeMed BV 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 less than seven days. The MeMed BV test generates a numeric score that falls within discrete interpretation bins based on the increasing likelihood of bacterial infection.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210254 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210254: MeMed BV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210254
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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