(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/mLAFP-L3: 0.028 ng/mLDCP: 0.042 ng/mL |
| Linearity/Reportable Range | "Full assay linearity was demonstrated" over claimed ranges. | Total AFP: 0.3 - 1000 ng/mLAFP-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/mLDCP (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% (< 1 ng/mL) | Total AFP: 0.7% to 1.5%AFP-L3%: 0.3% to 5.6%DCP: 1.1% to 6.7% |
| Total Precision | Total AFP & AFP-L3%: CV% within 10%DCP: CV% within 10% (≥ 1 ng/mL), within 15% (< 1 ng/mL) | Total AFP: 1.4% to 3.1%AFP-L3%: 0.4% to 6.3%DCP: 1.3% to 7.9% |
| Reproducibility (Instrument to Instrument) | Total AFP & AFP-L3%: CV% within 10%DCP: CV% within 10% | Total AFP & AFP-L3%: 1.6% to 2.7%DCP: 4.9% to 5.6% |
| Recovery | Not explicitly stated; "evaluated the accuracy" implies acceptable recovery. | Total AFP: 97.8% to 104.9%AFP-L3%: 98.1% to 100.9%DCP: 94.0% to 111.6% |
| Interference | "No significant effect" from potential interferents. | Total AFP & AFP-L3%: No significant effect from various interferents.DCP: No significant effect from various interferents (glucose and galactose not tested for DCP). |
| HAMA Interference | "No significant effect" from HAMA interferents. | No significant effect for Total AFP, AFP-L3%, and DCP assays. |
| Method Comparison/Correlation | "Acceptable correlation" with predicate device; Specific concordance rates for clinical cut-offs. | AFP-L3%: Concordance rate of 90.4% (at 10% clinical cut-off) between µTASWako i30 and LiBASys.DCP: Concordance rate of 95.5% (at 7.5 ng/mL clinical cut-off) between µTASWako i30 and LiBASys. |
| Stability | "Demonstrated stability according to the labeled storage conditions." | Long-term stability and stability after opening for reagent, calibrator set, and controls demonstrated. 30-day stability of one-time instrument calibration also supported. |
2. Sample Size Used for the Test Set and Data Provenance
- Sensitivity (LoD): Sample size not specified, but involved distinguishing analytes from blank.
- Linearity/Assay Reportable Range: Sample size not specified.
- High Dose Hook Effect: Sample size not specified.
- Within-Run Precision: Samples with Total AFP 10-950 ng/mL, AFP-L3% 6-80%, DCP 0.2-910 ng/mL. Number of runs/replicates not specified in summary.
- Total Precision: 7 pooled human serum samples and 2 levels of controls. Samples with Total AFP 10-950 ng/mL, AFP-L3% 6-80%, DCP 0.2-910 ng/mL. Measured over 21 days.
- Reproducibility (Instrument to Instrument): 24 instruments were used. Sample details not explicitly stated, but for AFP-L3 and DCP assays.
- Recovery: Sample details not explicitly stated.
- Interference: Tested with known amounts of various interfering substances. Sample details not explicitly stated.
- HAMA Interference: Tested with two types of HAMA interferents. Sample details not explicitly stated.
- Method Comparison/Correlation (AFP-L3 and DCP):
- Test Set: 200 samples from 100 patients.
- Additionally:
- AFP-L3: 40 serum samples spiked with AFP-L1 and AFP-L3.
- DCP: 20 serum samples spiked with DCP.
- Data Provenance: Not explicitly stated, but the studies were conducted to support a US FDA 510(k) submission, suggesting a focus on samples relevant to the intended patient population, likely from clinical settings. It is retrospective in the sense that the samples are collected and then tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes the analytical performance of an in vitro diagnostic (IVD) device. The "ground truth" for these types of studies is based on the quantitative measurement of analytes and comparison to a legally marketed predicate device (LiBASys instrument with LBA AFP-L3 and LBA DCP test systems). Therefore, human expert judgment in the diagnostic sense (e.g., radiologists interpreting images) is not applicable or described in this context. The "ground truth" for the method comparison studies would be the results obtained from the predicate device (LiBASys).
4. Adjudication Method for the Test Set
Not applicable. The studies described are analytical performance studies, not subjective diagnostic interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is an IVD immunoassay system, not an AI-assisted diagnostic imaging device that involves human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance data presented is inherently "standalone" in the context of the device's function, as it evaluates the instrument and test systems' analytical capabilities directly. The µTASWako i30 Immunoanalyzer System is a fully automated immunoassay system that performs sampling, mixing, separation, and fluorescence detection. Its output (quantitative measurements of AFP-L3% and DCP) does not involve human interpretation in the same way an AI imaging algorithm would. The method comparison studies compare the new device's automated results directly against a predicate automated device.
7. The Type of Ground Truth Used
The ground truth for the analytical performance studies is largely based on:
- Reference Standards: For sensitivity and linearity, the accurate measurement of known concentrations of analytes.
- Predicate Device Results: For the method comparison/correlation studies, the results obtained from the legally marketed predicate devices (LiBASys instrument with LBA AFP-L3 and LBA DCP test systems) are used as the comparative "ground truth."
- Clinical Cut-off Values: For calculating concordance rates (e.g., 10% for AFP-L3%, 7.5 ng/mL for DCP), these are established clinical values, not derived from a de novo ground truth for the study but rather applied to the measured values.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning or AI development. These are validation studies for an IVD device. The methods described include validation of reagents, calibrators, and system performance through various analytical tests (precision, linearity, recovery, etc.).
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a "training set" in the context of an AI/ML algorithm. The studies conducted are for analytical validation of an IVD system against established analytical performance metrics and comparison to a predicate device.
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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
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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
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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.
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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 ofSubject andPredicate Devices | µTASWako i30System used withµTASWako AFP-L3and µTASWako DCPTest Systems(Subject Device) | LiBASys Systemused withLBA AFP-L3 and LBADCP Test Systems(Predicate Device) |
|---|---|---|---|
| Analytes AssayedMode of Operation | Same | AFP/AFP-L3%, DCP | AFP/AFP-L3, DCP |
| Test Principle | Similar | Automatedfluorescence analyzerFluorescence liquid-phase bindingimmunoassay system | Automated fluorescenceanalyzerFluorescence liquid-phase binding enzymeimmunoassay system |
| Rationale:i30 technologyrequires fluorescentdye | |||
| Operation Methodology | Similar | Quantitative,fluorescenceimmunoassay,electrophoresisseparation | Quantitative,fluorescenceimmunoassay,chromatographicseparation |
| Rationale:Although theseparationmethodologies aredifferent, testprinciple remains thesame. | |||
| FluorescenceTechnology | Different | Light Source:Diode laser (638 nm)Detector:Photo Diode Detector | Light Source:Deuterium LampDetector:Photometric Detector |
| Rationale:i30 technology doesnot use enzyme-linked fluorescencedetection. | |||
| Sample Matrix | Same | Human Serum | Human Serum |
| Reference Standard | Same | 1st internationalstandard for alpha-fetoprotein from NIBSCrecognized by WHO | 1st international standardfor alpha-fetoprotein fromNIBSC recognized byWHO |
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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 (< 1 ng/mL). With respect to all samples, the CV% results ranged from 1.1% to 6.7% for DCP.
(5) Total Precision:
AFP-L3: Total precision studies were performed for the AFP-L3 assay over the reportable range for both Total AFP and AFP-L3% using 7 pooled human serum samples and 2 levels of controls. Three of the samples were pooled human serum samples near the clinical decision point and were prepared without spiking with analytes. The samples 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%" for all samples. The results of CV%, measured over 21 days, for all samples ranged from 1.4% to 3.1% for Total AFP and ranged from 0.4% to 6.3% AFP-L3%.
DCP: Total precision studies were performed for the DCP assay over the reportable range using 7 pooled human serum samples and 2 levels of controls. Three of the samples were pooled human serum samples near the clinical decision point and were prepared without spiking with analyte. The samples ranged from 0.2 to 910 ng/mL in
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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 (< 1 ng/mL). The results of CV%, measured over 21 days, for all samples ranged from 1.3% to 7.9%.
(6) Reproducibility (Instrument to Instrument)
The instrument-to-instrument reproducibility study by using 24 instruments evaluated the precision performance characteristics (between-instrument) for AFP-L3 and DCP assays. The acceptance criterion for percent CV (CV%) was set at "within 10%" for both Total AFP and AFP-L3% and set at "within 10%" for DCP. The results ranged from 1.6% to 2.7% for both Total AFP and AFP-L3% and ranged from 4.9% and 5.6% for DCP.
(7) Recovery
The recovery study evaluated the accuracy of quantitative "AFP-L3" and "DCP" assays. Percent recovery was determined as a percentage of expected value (%: obtained value divided by expected value X 100). The results of recovery (%) ranged from 97.8% to 104.9 % for Total AFP and ranged from 98.1% to 100.9 % for AFP-L3%. The results of recovery (%) ranged from 94.0% to 111.6% for DCP.
(8) Interference
Potential interfering substances were evaluated by determining recovery performance in the presence of known amounts, including concentrations higher than expected in whole blood, of the following substances: Hemoglobin, Billrubin, Coniugated bilirubin. Triglycerides, Ascorbic acid. Glucose, Galactose, Rheumatoid factor, Vitamin B1, Vitamin B6, Vitamin B12, Ibuprofen, Acetaminophen, Acetylsalicylic acid, IFN-q, IFN-q, For Total AFP and AFP-L3% assay, no significant effect from the potential interferents occurred. For the DCP assay, no significant effect from the potential interferents occurred. Glucose and galactose were not tested for the DCP assay.
(9) HAMA Interference
Potential inferences of two types of HAMA interferents (Type 1 SQ and Type 2L SQ) were evaluated at concentrations higher than expected in whole blood by determining recovery performance. No significant effect from the HAMA interferents occurred for the Total AFP, AFP-L3%, and DCP assays.
(10) Method Comparison/ Correlation
uTASWako AFP-L3:
A comparison of the uTASWako AFP-L3 to a similar AFP-L3 assay (LBA AFP-L3) was performed using uTASWako i30 and LiBASys, respectively. A comparison study of 200 samples from 100 patients was conducted by both instruments. In addition, 40 serum samples spiked with AFP-L1 and AFP-L3 to cover the upper part of the reportable range were studied.
Deming analysis. excluding two outliers, shows acceptable correlation with and without spiked samples, as demonstrated in the correlation graphs given herein. Correlation #1 shows the Deming regression analysis of AFP-L3% values, with spiked samples and without outliers, run on uTASWako i30 and LiBASys. Correlation #2 shows the Deming regression analysis of AFP-L3% values, without spiked samples and without outliers.
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X = LBA AFP-L3 (LiBASys)
Y = μTASWako AFP-L3 (μTASWako i30)
uTASWako AFP-L3 Correlation #1
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µTASWako AFP-L3 Correlation #2
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Using the data from correlation #2 and the clinical cut-off value of 10%, a concordance rate (overall agreement) of 90.4% was found.
μTASWako DCP:
A comparison of the uTASWako DCP to a similar DCP assay (LBA DCP) was performed using uTASWako i30 and LiBASys, respectively. A comparison study of 200 samples from 100 patients was conducted by both instruments. In addition, 20 serum samples spiked with DCP to cover the upper part of the reportable range were studied.
Deming analysis shows acceptable correlation with and without spiked samples, as demonstrated in the correlation graphs given herein. Correlation #1 shows the Deming regression analysis of DCP values, with spiked samples, run on uTASWako i30 and LiBASys. Correlation #2 shows the Deming regression analysis of DCP values, without spiked samples.
X = LBA DCP (LiBASys)
Y = μTASWako DCP (μTASWako i30)
uTASWako DCP Correlation #1
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|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------. | |
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μTASWako DCP Correlation #2
| Antoneral And Article A. Box A. Box A. Box A. | A SEE AND SHORE A LANDING COLLEGE A------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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Using the data from correlation # 2 and the clinical cut-off value of 7.5 ng/mL, a concordance rate (overall agreement) of 95.5% was found.
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(11) Stabilitv
Wako
Long-term stability and stability after opening (on-board the instrument) were evaluated for the reagent, calibrator set, and two levels of controls for both assays. The results demonstrated stability according to the labeled storage conditions. In addition, during 30 days, stability of one-time instrument calibration using the same container of reagent (opened and stored on-board) was evaluated and found to support use of the same calibration curve.
Rationale for Substantial Equivalence:
Substantial equivalence of uTASWako i30 Immunoanalyzer System as intended for use with the uTASWako AFP-L3 and uTASWako DCP Immunological Test Systems, including the associated calibrators and controls, is determined to be substantially equivalent to the predicates based upon the comparison of intended use/ indications for use, technological characteristics/ technical specifications and the results of performance testing (non-clinical).
The differences that exist arise due to the use of technology that improves the analytical capability for the AFP/AFP-L3% and DCP analytes assaved. These differences do not alter the safety and effectiveness of Subject Device.
Conclusion:
The non-clinical tests performed using the uTASWako i30 Immunoanalyzer System with the uTASWako AFP-L3 and uTASWako DCP Immunological Test Systems, including the associated calibrators and controls, demonstrate that the system is as safe, effective, and performs as well as the legally marketed predicate devices identified above.
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Image /page/8/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle image.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
KAR 0 1 2011
Wako Chemicals, USA, Inc. Wako Diagnostics c/o Martha Murari, Ph.D., RAC Manager, Regulatory Affairs 1025 Terra Bella Ave, Suite A Mountain View, CA 94043
Re: K100464
Trade/Device Name: Wako uTASWako AFP-L3 Immunological Test System Wako uTASWako DCP Immunological Test System Wako uTASWako i30 Immunoanalyzer System Wako µTASWako AFP-L3 Calibrator Set Wako µTASWako AFP-L3 Control L and Control H Wako uTASWako DCP Calibrator Set Wako µTASWako DCP Control L and Control H Regulation Number: 21CFR§866.6030 Regulation Name: AFP-L3% Immunological Test System Regulatory Class: Class II Product Code: NSF, OAU, OUE, JIT, JJX Dated: February 14, 2011 Received: February 15, 2011
Dear Dr. Murari:
This letter corrects our substantially equivalent letter of February 23, 2011.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Martha Murari, Ph.D., RAC
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/Medical Devices/Resourcesfor You/Industry/default.html.
Sincerely yours.
ia mchen
Maria M. Chan, Ph.D Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Wako uTASWako AFP-L3 Immunological Test System and Wako µTASWako DCP Immunological Test System
Indications for Use for µTASWako AFP-L3 Immunological Test System:
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.
Indications for Use for uTASWako DCP Immunological Test System:
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.
Prescription Use _ X Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Reena Philip
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K100464
Page 2 of 4
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510(k) Number (if known):
Device Name: Wako uTASWako i30 Immunoanalyzer
The uTASWako i30 Immunoanalyzer is an in vitro diagnostic automated instrument intended for use to quantitatively measure analytes in clinical chemistry by immunochemical techniques. The µTASWako i30 Immunoanalyzer is indicated for use by healthcare professionals. It is intended for assays cleared or approved for use on this instrument.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Reena Philip
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k 100464
Page 1 of _ 4
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510(k) Number (if known):
Device Name: Wako uTASWako AFP-L3 Calibrator Set, Wako uTASWako AFP-L3 Control L, and Wako µTASWako AFP-L3 Control H
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.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | |
|---|---|
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Reena Philip
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K100464
Page 3 of 4_
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510(k) Number (if known):
Device Name: Wako uTASWako DCP Calibrator Set, Wako uTASWako DCP Control L, and 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 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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Quena Philip
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K100464
Page 4 of 4
§ 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.