# K230944: MeMed BV

- Pathway: 510(k) (Traditional)
- Applicant: MeMed Diagnostics, Ltd.
- Decided: Jun 30, 2023 after 87 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: 5 generations back to K071146 (2007). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222332: MeMed BV, MeMed Diagnostics, Ltd. (2023) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K230944
Methodology: https://510kreport.com/methodology