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 Jun 30, 2023 as substantially equivalent to K222332 (MeMed Diagnostics, Ltd., 2023) after an 87-day review. Its family tree reaches back 5 generations to 2007.
- Decided
- Jun 30, 2023
- Review
- 87 days
- Class
- Class II
- Product code
- QPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K071146 (2007). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK071146 Vidas B.R.a.H.M.S. PCT AssaybioMerieux, Inc. · 2007 · Recalled
- 4 generations backK160911 Vidas B.R.a.H.M.S. PCT (PCT)bioMerieux, Inc. · 2016
- 3 generations backK162827 Vidas B.R.a.H.M.S. PCT (PCT)bioMerieux, Inc. · 2017
- 2 generations backK210254 MeMed BVMeMed Diagnostics, Ltd. · 2021
- 1 generation backK222332 MeMed BVMeMed Diagnostics, Ltd. · 2023
- This deviceK230944 MeMed BVMeMed Diagnostics, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K071146 | Vidas B.R.a.H.M.S. PCT Assay | bioMerieux, Inc. | 2007 | 1 |
| −4 | K160911 | Vidas B.R.a.H.M.S. PCT (PCT) | bioMerieux, Inc. | 2016 | — |
| −3 | K162827 | Vidas B.R.a.H.M.S. PCT (PCT) | bioMerieux, Inc. | 2017 | — |
| −2 | K210254 | MeMed BV | MeMed Diagnostics, Ltd. | 2021 | — |
| −1 | K222332 | MeMed BV | MeMed Diagnostics, Ltd. | 2023 | — |
| 0 (this device) | K230944 | MeMed BV | MeMed Diagnostics, Ltd. | 2023 | — |
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 |
|---|---|---|---|
| * | K222332 | MeMed BVSummary page 4…ment of patients with suspected sepsis Regulatory Class: Class II, 21 CFR 866.3215 Product Code: QPS Predicate Devices MeMed Diagnostics LTD., MeMed BV® (K222332) Device Description The MeMed BV® (“BV test” or the “test”) is an In-Vitro-Diagnostic device that measures in… | 2023 |
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 16 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
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. 2023, 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 and venous whole blood 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…
Read the full statement (116 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 and venous whole blood 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 as stated in the FDA summary.
https://510kreport.com/device/K230944 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230944: 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/K230944
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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