(370 days)
The µTASWako AFP-L3 Immunological Test System is an in vitro device that consists of reagents used with the uTASWako i30 Immunoanalyzer to quantitatively measure, by immunochemical techniques, AFP-L3% 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 (HCC) in conjunction with other laboratory findings, imaging studies and clinical assessment. Patients with elevated AFP-L3% values (≥ 10%) have been shown to be associated with an increase in the risk of developing HCC within the next 21 months and should be more intensely evaluated for evidence of HCC according to the existing HCC practice guidelines in oncology.
The uTASWako DCP Immunological Test System is an in vitro device that consists of reagents used with the µTASWako i30 Immunoanalyzer 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 development of hepatocellular carcinoma (HCC) in conjunction with other laboratory findings, imaging studies, and clinical assessment.
The µTASWako i30 Immunoanalyzer is an in vitro diagnostic automated instrument intended for use to quantitatively measure analytes in clinical chemistry by immunochemical techniques. The uTASWako i30 Immunoanalyzer is indicated for use by healthcare professionals. It is intended for assays cleared or approved for use on this instrument.
The Wako uTASWako AFP-L3 Calibrator Set is designed to be used with the Wako µTASWako AFP-L3 Immunological Test System for the quantitative determination of AFP-L3% in human serum.
The Wako µTASWako AFP-L3 Control L is designed to be used as quality control material for the quantitative determination of AFP-L3% in human serum using the Wako µTASWako AFP-L3 Immunological Test System.
The Wako uTASWako AFP-L3 Control H is designed to be used as quality control material for the quantitative determination of AFP-L3% in human serum using the Wako uTASWako AFP-L3 Immunological Test System.
The Wako µTASWako DCP Calibrator Set is designed to be used with the Wako uTASWako DCP Immunological Test System for the quantitative determination of DCP in human serum.
The Wako µTASWako DCP Control L is designed to be used as a quality control material for the quantitative determination of DCP in human serum using the Wako µTASWako DCP Immunological Test System.
The Wako µTASWako DCP Control H is designed to be used as a quality control material for the quantitative determination of DCP in human serum using the Wako uTASWako DCP Immunological Test System.
The µTASWako i30 Immunoanalyzer System is a fully automated immunoassay system that can perform assays of the uTASWako AFP-L3 and µTASWako DCP Immunological Test Systems. This system automatically conducts sampling, mixing, separation, and fluorescence detection on a microfluidic chip to achieve high sensitivity and accuracy. The instrument contains an automated liquid dispenser, temperature controlled reagent container, chip station, analysis compartment, and sample rack station. The outside panel has a printer and a touch panel with a menu to order measurements and to check the availability for reagent, chip, wash solution, and pure water. A chip is used for each test and is disposable. The instrument is designed to automatically and constantly monitor the reagents, chips, dispensing system and the measurement process so that measurement results are not given when an error occurs.
The system is comprised of the following products:
uTASWako i30
uTASWako AFP-L3, Calibrator Set, Control L and Control H
uTASWako DCP, Calibrator Set, Control L and Control H
Instrument and assay accessories as per labeling
The provided text describes the performance data for the µTASWako i30 Immunoanalyzer System and its associated AFP-L3 and DCP immunological test systems. This is a medical device, and the criteria and studies described relate to analytical performance, not clinical diagnostic accuracy or reader studies with human experts.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sensitivity (LoD) | Not explicitly stated; "distinguished from blank" implied. | AFP-L1: 0.030 ng/mL |
| AFP-L3: 0.028 ng/mL | ||
| DCP: 0.042 ng/mL | ||
| Linearity/Reportable Range | "Full assay linearity was demonstrated" over claimed ranges. | Total AFP: 0.3 - 1000 ng/mL |
| AFP-L3%: 0.5 - 99.5% | ||
| DCP: 0.1 - 950 ng/mL | ||
| High Dose Hook Effect | "No effect" of high concentration. | Total AFP (for AFP-L3 assay): No effect up to 1,272,000 ng/mL |
| DCP (for DCP assay): No effect up to 23,000 ng/mL | ||
| Within-Run Precision | Total AFP & AFP-L3%: CV% within 10% | |
| DCP: CV% within 10% (≥ 1 ng/mL), within 15% ( |
§ 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.