(170 days)
The Wako LBA DCP immunological test system is an in vitro device that consists of reagents and an automated instrument used to quantitatively measure by immunochemical techniques DCP in human serum. The device is intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma in conjunction with other laboratory findings, imaging studies and clinical assessment.
The Wako LBA DCP immunological test system is an in vitro device that consists of reagents and an automated instrument used to quantitatively measure by immunochemical techniques DCP in human serum. The Wako LBA DCP assay is test kit for the quantitative determination of DCP based on a new method, LBA (Liquid-phase Binding Assay). The method uses a liquid-phase binding reaction between antigen and antibody and separates bound and free forms by column chromatography without a need for a solid phase. LBA DCP can offer fully automatic and highly precise DCP measurement by using an automated analyzer "LiBASys". This reagent consists of anti-DCP monoclonal antibodies and anti-Prothrombin monoclonal antibodies which are used as Fab' molecules and a substrate for fluorophotometric measurement.
Here's a breakdown of the acceptance criteria and study details for the Wako LBA DCP immunological test system, based on the provided text:
Acceptance Criteria and Reported Device Performance
The provided document defines the device's utility in terms of its ability to identify patients at risk of developing HCC. A specific threshold for DCP concentration (≥ 7.5 ng/mL) is used to categorize risk. The primary performance metric presented is the relative risk.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Relative Risk of developing HCC with an elevated DCP test result (≥ 7.5 ng/mL) compared to a negative DCP test result ( |
§ 866.6030 AFP-L3% immunological test system.
(a)
Identification. An AFP-L3% immunological test system is an in vitro device that consists of reagents and an automated instrument used to quantitatively measure, by immunochemical techniques, AFP and AFP-L3 subfraction in human serum. The device is intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma, in conjunction with other laboratory findings, imaging studies, and clinical assessment.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: AFP-L3% Immunological Test Systems.” See § 866.1(e) for the availability of this guidance document.