(370 days)
Not Found
No
The summary describes a fully automated immunoassay system that performs quantitative measurements using immunochemical techniques. There is no mention of AI or ML in the intended use, device description, or performance studies. The system's automation and monitoring features are based on standard instrument control and error detection, not AI/ML algorithms.
No
Explanation: This device is an in vitro diagnostic (IVD) system used to measure specific markers in human serum to aid in the risk assessment for hepatocellular carcinoma. It is not used for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that 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)".
No
The device description explicitly details a physical instrument, the µTASWako i30 Immunoanalyzer, which is a fully automated immunoassay system with hardware components like a liquid dispenser, temperature-controlled reagent container, chip station, analysis compartment, and sample rack station. The software is part of a larger system that includes hardware and reagents.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The µTASWako AFP-L3 Immunological Test System is an in vitro device..."
- "The device is intended for in vitro diagnostic use..."
- "The uTASWako DCP Immunological Test System is an in vitro device..."
- "The device is intended for in vitro diagnostic use..."
- "The µTASWako i30 Immunoanalyzer is an in vitro diagnostic automated instrument..."
These statements clearly indicate that the entire system, including the test systems, the analyzer, and the associated calibrators and controls, are intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
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 uTASWako 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 uTASWako 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 uTASWako 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.
Product codes (comma separated list FDA assigned to the subject device)
NSF, OAU, OUE, JIT, JJX
Device Description
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:
µTASWako i30
µTASWako AFP-L3, Calibrator Set, Control L and Control H
µTASWako DCP, Calibrator Set, Control L and Control H
Instrument and assay accessories as per labeling
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare professionals / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
(1) Sensitivity: The analytical sensitivity for the AFP-L3 and DCP assays was determined as the limit of detection, the point at which the analytes are distinguished from blank. The LoD for AFP-L1 and AFP-L3 was found to be 0.030 ng/mL and 0.028 ng/mL, respectively. The LoD for DCP was found to be 0.042 ng/mL.
(2) Linearity/Assay Reportable Range: Linearity for the AFP-L3 and DCP assays was evaluated following a linear regression analysis and 95% confidence intervals of the data points. Full assay linearity was demonstrated over the claimed reportable ranges of 0.3 - 1000 ng/mL for Total AFP and of 0.5 - 99.5% for AFP-L3%. Full assay linearity was demonstrated over the claimed reportable range of 0.1 - 950 ng/mL for DCP.
(3) High Dose Hook Effect: A high dose hook effect study demonstrated no effect of high concentration of Total AFP, up to 1,272,000 ng/mL, for the quantitative AFP-L3 assay. A high dose hook effect study demonstrated no effect of high concentration of DCP, up to 23,000 ng/mL, for the quantitative DCP assay.
(4) Within-Run Precision:
AFP-L3: Within-run precision studies were performed for the AFP-L3 assay over the reportable range for both Total AFP and AFP-L3% using samples that ranged from 10 to 950 ng/mL in Total AFP concentration and ranged from approximately 6% to 80% in AFP-L3%. The acceptance criterion for percent CV (CV%) was set at "within 10%". With respect to all samples, the CV% results ranged from 0.7% to 1.5% for Total AFP and ranged from 0.3% to 5.6% for AFP-L3%.
DCP: Within-run precision studies were performed for the DCP assay over the reportable range for DCP using samples that ranged from 0.2 to 910 ng/mL in DCP concentration. The acceptance criteria for percent CV (CV%) was set at "within 10%" for DCP across upper reportable range (≥ 1 ng/mL) or "within 15%" for DCP across lower reportable range (
§ 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.
0
FEB 2 3 2011
Wako
Traditional 510(k)
µTASWako® i30 Analyzer and Test Systems
510(k) Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: K100464
Applicant Information:
Name:
Wako Chemicals, USA, Inc. Wako Diagnostics
USA Headquarters Address:
1600 Bellwood Road Richmond, VA 23237
Contact:
Martha Murari, Ph.D., RAC Manager, Regulatory Affairs Wako Chemicals, USA, Inc. Wako Diagnostics 1025 Terra Bella Ave., Suite A Mountain View, CA 94043 Phone: (650) 210-9153 Ext. 133 Fax: 650-210-9170
Hiroyuki Yamada, M.S. Manager, Clinical Research Wako Chemicals, USA. Inc. Wako Diagnostics 1025 Terra Bella Ave., Suite A Mountain View, CA 94043
Date Prepared:
February 14, 2011
Device Information:
Primary Trade Names:
µTASWako i30 Immunoanalyzer System with uTASWako AFP-L3 Immunological Test System and uTASWako DCP Immunological Test System
µTASWako AFP-L3 Calibrator Set, µTASWako AFP-L3 Control L, and µTASWako AFP-L3 Control H
uTASWako DCP Calibrator Set, uTASWako DCP Control L, and pTASWako DCP Control H
Primary Classification Name:
AFP-L3% Immunological Test System
21 CFR $866.6030
Peter Panfili, Ph.D. General Manager Wako Chemicals, USA, Inc. Wako Diagnostics 1025 Terra Bella Ave., Suite A Mountain View, CA 94043 (650) 210-9153 Ext. 109 Fax: 650-210-9170
Lori Creasy, RAC Requiatory Specialist Wako Chemicals, USA, Inc. Wako Diagnostics 1600 Bellwood Road Richmond, VA 23237
1
Image /page/1/Picture/1 description: The image contains the word "Wako" in white text against a black background. The font appears to be sans-serif and slightly bolded. The text is horizontally oriented and centered within the image frame.
Predicate Devices:
The µTASWako AFP-L3 Immunological Test System, including the associated calibrators and controls, was previously cleared as LBA AFP-L3 for use with the LiBASys instrument under K041847 and was assigned product code NSF for the system in its entirety.
The uTASWako DCP Immunological Test System, including the associated calibrators and controls, was previously cleared as LBA DCP for use with the LiBASys instrument under K062368 and was assigned product code OAU for the reagent. The product codes assigned for calibrators and controls were JIT and JJX, respectively.
Device Description:
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
Intended Use/ Indications for Use Statement:
The statements for the µTASWako AFP-L3 and µTASWako DCP Immunological Test Systems, the uTASWako i30 Immunoanalyzer System, and the Calibrator Set and Controls for each test system are as follows:
Indications for Use for the Wako uTASWako AFP-L3 Immunological Test System:
The uTASWako AFP-L3 Immunological Test System is an in vitro device that consists of reagents used with the uTASWako i30 Immunoanalyzer to guantitatively 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 coniunction 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 intenselv evaluated for evidence of HCC according to the existing HCC practice quidelines in oncology.
continued
2
Indications for Use for the Wako µTASWako DCP Immunological Test System: The uTASWako DCP Immunological Test System is an in vitro device that consists of reagents used with the uTASWako 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.
Indications for Use for the Wako µTASWako i30 Immunoanalyzer System: 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.
lndications for Use for the Wako uTASWako AFP-L3 Calibrator Set, the Wako µTASWako AFP-L3 Control L. and the Wako uTASWako AFP-L3 Control H: The Wako uTASWako AFP-L3 Calibrator Set is designed to be used with the Wako uTASWako 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.
Indications for Use for the Wako uTASWako DCP Calibrator Set, the Wako uTASWako DCP Control L, and the Wako uTASWako DCP Control H: 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 uTASWako 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 มTASWako DCP Immunological Test System.
The Wako uTASWako 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.
3
Brief Summary of Technological Characteristics:
The following table briefly outlines technological characteristics of the Subject Device in comparison to the legally marketed predicate devices.
| Characteristic | Comparison of
Subject and
Predicate Devices | µTASWako i30
System used with
µTASWako AFP-L3
and µTASWako DCP
Test Systems
(Subject Device) | LiBASys System
used with
LBA AFP-L3 and LBA
DCP Test Systems
(Predicate Device) |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Analytes Assayed
Mode of Operation | Same | AFP/AFP-L3%, DCP | AFP/AFP-L3, DCP |
| Test Principle | Similar | Automated
fluorescence analyzer
Fluorescence liquid-
phase binding
immunoassay system | Automated fluorescence
analyzer
Fluorescence liquid-
phase binding enzyme
immunoassay system |
| | Rationale:
i30 technology
requires fluorescent
dye | | |
| Operation Methodology | Similar | Quantitative,
fluorescence
immunoassay,
electrophoresis
separation | Quantitative,
fluorescence
immunoassay,
chromatographic
separation |
| | Rationale:
Although the
separation
methodologies are
different, test
principle remains the
same. | | |
| Fluorescence
Technology | Different | Light Source:
Diode laser (638 nm)
Detector:
Photo Diode Detector | Light Source:
Deuterium Lamp
Detector:
Photometric Detector |
| | Rationale:
i30 technology does
not use enzyme-
linked fluorescence
detection. | | |
| Sample Matrix | Same | Human Serum | Human Serum |
| Reference Standard | Same | 1st international
standard for alpha-
fetoprotein from NIBSC
recognized by WHO | 1st international standard
for alpha-fetoprotein from
NIBSC recognized by
WHO |
4
Image /page/4/Picture/1 description: The image shows the word "Wako" in white text against a black background. The font is bold and sans-serif. The letters are evenly spaced and easily readable. The image is simple and clear, with a focus on the text.
Summary of Performance Data:
(1) Sensitivity:
The analytical sensitivity for the AFP-L3 and DCP assays was determined as the limit of detection, the point at which the analytes are distinguished from blank. The LoD for AFP-L1 and AFP-L3 was found to be 0.030 ng/mL and 0.028 ng/mL, respectively. The LoD for DCP was found to be 0.042 ng/mL.
(2) Linearity/ Assay Reportable Range:
Linearity for the AFP-L3 and DCP assays was evaluated following a linear regression analysis and 95% confidence intervals of the data points. Full assay linearity was demonstrated over the claimed reportable ranges of 0.3 - 1000 ng/mL for Total AFP and of 0.5 - 99.5% for AFP-L3%. Full assay linearity was demonstrated over the claimed reportable range of 0.1 - 950 ng/mL for DCP.
(3) High Dose Hook Effect:
A high dose hook effect study demonstrated no effect of high concentration of Total AFP, up to 1,272,000 ng/mL, for the quantitative AFP-L3 assay. A high dose hook effect study demonstrated no effect of high concentration of DCP, up to 23,000 ng/mL, for the quantitative DCP assay.
(4) Within-Run Precision:
AFP-L3: Within-run precision studies were performed for the AFP-L3 assay over the reportable range for both Total AFP and AFP-L3% using samples that ranged from 10 to 950 ng/mL in Total AFP concentration and ranged from approximately 6% to 80% in AFP-L3%. The acceptance criterion for percent CV (CV%) was set at "within 10%". With respect to all samples, the CV% results ranged from 0.7% to 1.5% for Total AFP and ranged from 0.3% to 5.6% for AFP-L3%.
DCP: Within-run precision studies were performed for the DCP assay over the reportable range for DCP using samples that ranged from 0.2 to 910 ng/mL in DCP concentration. The acceptance criteria for percent CV (CV%) was set at "within 10%" for DCP across upper reportable range (≥ 1 ng/mL) or "within 15%" for DCP across lower reportable range (