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510(k) Data Aggregation
K Number
K230944Device Name
MeMed BV
Manufacturer
MeMed Diagnostics Ltd.
Date Cleared
2023-06-30
(87 days)
Product Code
QPS
Regulation Number
866.3215Why did this record match?
Applicant Name (Manufacturer) :
MeMed Diagnostics Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 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.
Device Description
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.
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K Number
K222332Device Name
MeMed BV
Manufacturer
MeMed Diagnostics Ltd.
Date Cleared
2023-03-23
(233 days)
Product Code
QPS
Regulation Number
866.3215Why did this record match?
Applicant Name (Manufacturer) :
MeMed Diagnostics Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 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 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.
Device Description
The Med 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 chemiluminescencebased analyte measurements of patient serum 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.
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K Number
K210254Device Name
MeMed BV
Manufacturer
MeMed Diagnostics Ltd.
Date Cleared
2021-09-01
(215 days)
Product Code
QPS
Regulation Number
866.3215Why did this record match?
Applicant Name (Manufacturer) :
MeMed Diagnostics Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 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.
Device Description
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 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.
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