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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 pediatic 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.

The MeMed BV® ("BV test" or the "test") is an In-Vitro-Diagnostic device that measures in parallel the blood concentrations of TRAIL, IP-10 and CRP. The test consists of an automated analyzer with built-in hardware and software that conduct chemiluminescence based analyte measurements of patient serum and venous whole blood samples and their computational integration (MeMed Key®), and a disposable cartridge that contains the reagents and controls needed to detect the analytes of interest (MeMed BV® cartridge). The test generates an answer to each sample, with a test run time of approximately 15 minutes.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for MeMed BV:

The MeMed BV test is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection in patients presenting to the emergency department or urgent care center, or with samples collected at hospital admission, who have had symptoms for less than seven days. The device generates a numeric score that falls within discrete interpretation bins based on the increasing likelihood of bacterial infection.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary details various analytical performance studies and a clinical study to support the expanded indications for use. Key acceptance criteria and reported performance include:

3. Absolute bias

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