(42 days)
No predicate
The text states "No predicate" under "Predicate Device(s)" and "Not Found" under "Reference Device(s)". Therefore, there are no reference devices K/DEN numbers to list.
No
The device description and performance studies focus on a biochemical assay and statistical analysis of risk based on a threshold value, with no mention of AI or ML algorithms.
No
The device is described as a risk assessment test for the development of hepatocellular carcinoma (HCC), not a device used to provide therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the Wako AFP-L3% assay is "intended as a risk assessment test for the development of hepatocellular carcinoma (HCC) in patients with chronic liver diseases (CLD)." Risk assessment for disease development is a diagnostic function.
No
The device description explicitly lists physical components including reagents, a column, and mentions use with an automated analyzer (LiBASys), indicating it is a hardware-based device with associated consumables.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the assay is used to assess the risk of developing hepatocellular carcinoma (HCC) in patients with chronic liver diseases. This involves analyzing a biological sample (serum) to provide information about a patient's health status and risk.
- Device Description: The device consists of reagents and a column designed to perform a specific assay on a biological sample. This is characteristic of an in vitro diagnostic test kit.
- Performance Studies: The description includes details of a clinical study where the device was used to test serum samples from patients and the results were analyzed to determine the device's performance in assessing HCC risk. This type of clinical validation is required for IVDs.
- Key Metrics: The results are presented in terms of risk percentages and relative risk, which are metrics used to evaluate the clinical utility of a diagnostic test.
- Sample Type: The assay is performed on serum samples, which are biological specimens taken from the body.
The definition of an IVD generally involves devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Wako AFP-L3% assay fits this definition by analyzing serum to assess the risk of developing HCC.
N/A
Intended Use / Indications for Use
The Wako AFP-L3% assay is intended as a risk assessment test for the development of hepatocellular carcinoma (HCC) in patients with chronic liver diseases (CLD). Elevated AFPL3% values (≥ 10%) have been shown to be associated with a seven-fold increase in the risk of developing HCC within the next 21 months. Patients with elevated serum AFPL3% should be more intensely evaluated for evidence of HCC according to the existing HCC practice guidelines in oncology.
Product codes
NSF, JIT, JJX
Device Description
The Wako AFP-L3% device consists of reagent 1 (LCA and anion 1-conjugated anti-AFP mouse monoclonal antibody), reagent 2 (horseradish peroxidase (POD)labeled anti-AFP mouse monoclonal antibody and anion 2 conjugated anti-AFP mouse monoclonal antibody, substrate 1 (4 acetamidophenol in 2-propanol) and substrate 2 (hydrogen peroxide) and a column. Reagent 1, reagent 2 and the column are ready-to-use. Elution buffers A to C, sample cups, inside and outside cuvettes are sold separately from kit.
The Wako AFP-L3 Calibrator set and Control set are sold separately. The calibrator set consisted of Calibrator 1 and 2. Calibrator 1 contains human AFP -L1 fraction and Calibrator 2 has human AFP-L3 fraction. The control set consisted of Control 1 and 2, each containing different concentrations of human AFP-L1 and L-3.
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
The overall mean age was 52.6 y (SD = 7.0 y). Two subjects in Group 4 were less than 40 years old and were excluded from the analysis. The age range for males was 40-70 and for females was 40-70.
Intended User / Care Setting
For prescription use only.
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)
Analytical performance:
- Precision/Reproducibility:
- Within-run precision: Three control sera were assayed 21 times. Percent CV for AFP, AFP-L3, and AFP-L3% ranged from 1.4-1.5%, 1.6-3.7%, and 0.7-3.3% respectively.
- Total precision: Study performed according to CLSI Guideline EP5-A. Three control sera assayed in duplicates, two runs per day for 21 days. Total CV (%) for AFP, AFP-L3, and AFP-L3% ranged from 3.7-5.7%, 5.9-9.6%, and 2.7-6.4% respectively.
- Reproducibility: Performed by 3 clinical laboratories using two samples. Percent CV for AFP and AFP-L3 ranged from 1.0% to 3.9% and 1.5% to 6.9% respectively.
- Recovery: Five different concentrations of AFP were spiked into aliquots of 3 serum samples. Percent recovery for AFP and AFP-L3 ranged from 95.1% to 108.4% and 95.3% to 118.2% respectively.
- Linearity/Assay Reportable Range:
- Assay measuring range: 0.8 ng/mL to 1000 ng/mL.
- Linearity was evaluated according to CLSI Guideline EP6-A. Linear up to 1000 ng/mL AFP.
- Linearity studies performed in 3 clinical sites showed R2 values for Total AFP and AFP-L3% close to 1 (e.g., 0.9988 to 0.9997 for Total AFP; 0.9835 to 0.9999 for AFP-L3%).
- Detection limit (functional sensitivity): Minimal detectable concentration (MDC) for AFP was 0.26 ng/mL. Analytical sensitivity claim is 0.8 ng/mL. Functional sensitivity was established to be 10 ng/mL.
- Analytical specificity (Interference): Tested with hemoglobin, free bilirubin, conjugated bilirubin, intrafat, rheumatoid factor, glucose, galactose, and ascorbate. Glucose concentration >600 mg/dL and bilirubins >20 mg/dL can result in decreased AFP-L3%. Drug interference (Vitamins B1, B6, B12, interferons, ibuprofen, acetaminophen, acetylsalicylic acid) showed percent recoveries from 95.2% to 105.6%. HAMA interference showed percent recoveries from 94.5% to 100.1% for AFP, 95% to 112.8% for AFP-L3, and 97.9% to 113.5% for AFP-L3%.
Clinical studies:
- Longitudinal data analysis: A double-blind, multi-site prospective study with 496 patients with liver disease enrolled at 7 clinical sites.
- Objective: Observe a minimum of 30 subjects who developed verifiable HCC during the study.
- Patient Groups:
- Group 1: Newly diagnosed HCC.
- Group 2: Developed confirmed HCC during study.
- Group 3: Suspected of possibly HCC.
- Group 4: Did not have HCC.
- Primary Endpoint: Relative risk (with 95% CI) of developing HCC within the next 21 months in patients with AFP-L3% ≥10% as compared to the risk in patients with AFPL3%
§ 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.
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
A. 510(k) Number:
- B. Purpose for Submission: New device
- C. Analyte: AFP-L3%
- D. Type of Test:
Quantitative, fluorescence enzyme immunoassay
- E. Applicant: Wako Chemicals USA, Inc.
F. Proprietary and Established Names:
Wako LBA AFP-L3 Wako AFP-L3 Calibrator Set Wako AFP-L3 Control Set Wako LiBASys
G. Regulatory Information:
-
- Regulation section:
- 21 CFR§866.6030, AFP-L3% immunological test system
- 21 CFR§862.1150, Calibrator
- 21 CFR&862.1660. Ouality control material (assayed and unassayed)
-
- Classification:
AFP-L3% immunological test system - Class II Calibrator - Class II
Quality control material (assayed and unassayed) - Class I
-
- Product Code:
NSF, Test, Alpha Fetoprotein L3 subfraction (AFP-L3%) for hepatocellular carcinoma risk assessment
- Product Code:
-
JIT, Calibrator, Secondary
JJX, Single (specified) analyte controls (assayed and unassayed) -
- Panel:
Immunology (82), Chemistry (75)
- Panel:
H. Intended Use:
-
- Intended Use:
The Wako AFP-L3% assay is intended as a risk assessment test for the development of hepatocellular carcinoma (HCC) in patients with chronic liver diseases (CLD). Elevated AFPL3% values (≥ 10%) have been shown to be associated with a seven-fold increase in the risk of developing HCC within the next 21 months. Patients with elevated serum AFPL3% should be more intensely evaluated for evidence of HCC according to the existing HCC practice guidelines in oncology.
- Intended Use:
-
- Indication(s) for use: Same as intended use.
-
- Special condition for use statement(s):
1
For prescription use only.
-
- Special instrument Requirements: Use with automated analyzer LiBASys.
I. Device Description:
The Wako AFP-L3% device consists of reagent 1 (LCA and anion 1-conjugated anti-AFP mouse monoclonal antibody), reagent 2 (horseradish peroxidase (POD)labeled anti-AFP mouse monoclonal antibody and anion 2 conjugated anti-AFP mouse monoclonal antibody, substrate 1 (4 acetamidophenol in 2-propanol) and substrate 2 (hydrogen peroxide) and a column. Reagent 1, reagent 2 and the column are ready-to-use. Elution buffers A to C, sample cups, inside and outside cuvettes are sold separately from kit.
The Wako AFP-L3 Calibrator set and Control set are sold separately. The calibrator set consisted of Calibrator 1 and 2. Calibrator 1 contains human AFP -L1 fraction and Calibrator 2 has human AFP-L3 fraction. The control set consisted of Control 1 and 2, each containing different concentrations of human AFP-L1 and L-3.
J. Substantial Equivalence Information:
-
- Predicate device name(s): No predicate
-
- Predicate K number(s): Not applicable
-
- Comparison with predicate: Not applicable
K. Standard/Guidance Document Referenced (if applicable):
CLSI Guidelines EP5-A. EP7-A and EP6-A.
L. Test Principle:
Human AFP is a 70 kD glycoprotein with a single asparagine-linked carbohydrate chain. Using Lens culinaris agglutinin (LCA) which has an affinity for the carbohydrate chain that has an additional a 1-6 fucose residue bound to Nacetylgucosamine at the reducing end. AFP can be subdivided into 3 microheterogeneity forms, L1, L2 and L3. AFP L1 and L3 are major components of AFP in serum of HCC patients. AFP-L3% is the ratio of AFP with a 1-6 fucose residue to total AFP. The concentrations of LCA-reactive and LCAnonreactive AFP are measured separately using three anti-AFP monoclonal antibodies that detect different epitope, LCA and a fluorophotometric substrate. When a patient serum sample is mixed with LCA and anion 1 (sulfated tyrosine pentamer)-conjugated anti-AFP monoclonal antibody. LCA reacts with the sugar chain of LCA-reactive AFP while anion 1 conjugated anti-AFP monoclonal antibody binds to all AFP molecules forming immune complexes. When reagent 2 is added, immune complexes react with horseradish peroxidase (POD) labeled anti-AFP monoclonal antibody and anion 2 (sulfated tyrosine pentamer)conjugated anti-AFP monoclonal antibody. Anion 2- conjugated anti-AFP monoclonal antibody recognizes the base area of the sugar chain of APP and competes with previously reacted LCA on LCA-reactive AFP but binds to LCA non-reactive AFP without competitive reaction. The POD labeled anti-AFP
2
monoclonal antibody binds to all the AFP molecules in the sample. Therefore, two types of immune complexes with different anionic charges are formed. Complex 1 has 5 sulfate residues and complex 2 with 13 sulfate residues. The reaction mixture is introduced to an anion-exchange column and by means of stepwise gradient; immune complex fractions are separately eluted into reaction cups. The POD activity of each complex is measured and is determined as the increase of fluorescence intensity of 5,5 '-diacetoamide-2,2'-bisphenol formed by the reaction of hydrogen peroxide and 4-acetamidophenol. The total fluorescence intensity of complex 1 and 2 represents AFP concentration and AFP-L3% is complex 1/complex 1 + complex 2. AFP concentration and AFP-L3% are obtained by comparing to standards with known AFP concentration and AFP-L3%. (see illustration below)
Step 1: Addition of LCA and anion 1-conjugated anti-AFP monoclonal antibody
[Anion 1 conjugated anti-AFP monoclonal antibody}
[LCA-reactive AFP]—[LCA }
[Anion 1 conjugated anti-AFP monoclonal antibody }
[LCA non-reactive AFP]
- Step 2: Addition POD labeled anti-AFP monoclonal antibody and anion 2conjugated anti-AFP monoclonal antibody
Complex 1
[Anion 1 conjugated anti-AFP monoclonal]
[LCA-reactive AFP]—[LCA]
[POD labeled anti-AFP monoclonal]
Complex 2
[Anion 1 conjugated anti-AFP monoclonal]
[LCA non-reactive AFP]-[Anion 2-conjugated anti-AFP monoclonal]
[POD labeled anti-AFP monoclonal]
Step 3: Column separation
Step 4: Elution of immune complexes
Step 5: Addition of substrates
Step 6: Fluorescence detection
M. Performance Characteristics (if/when applicable):
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1. Analytical performance:
- a. Precision/Reproducibility:
Within-run precision - Three control sera with low, medium and high concentration of total AFP were assayed 21 times. Control serum #1 was prepared by spiking purified AFP-L1 and L-3 into pool serum. Results are shown in the following table.
| Control 1 | Control 2 | Control 3 | |||||||
|---|---|---|---|---|---|---|---|---|---|
| AFP | AFP-L3 | AFP- | AFP | AFP-L3 | AFP- | AFP | AFP-L3 | AFP- | |
| (ng/mL) | (ng/mL) | L3% | (ng/mL) | (ng/mL) | L3% | (ng/mL) | (ng/mL) | L3% | |
| Mean | 32.5 | 8.1 | 24.8 | 501.9 | 116.0 | 23.1 | 174.2 | 124.6 | 71.5 |
| SD | 0.48 | 0.29 | 0.82 | 7.31 | 4.30 | 0.70 | 2.39 | 2.01 | 0.53 |
| CV | 1.5 | 3.6 | 3.3 | 1.5 | 3.7 | 3.0 | 1.4 | 1.6 | 0.7 |
Total precision - Study was performed according to CLSI Guideline EP5-A. Three control sera were assayed in duplicates, two runs per day for 21 days. Results were summarized below.
| Sample 1 | Sample 2 | Sample 3 | |||||||
|---|---|---|---|---|---|---|---|---|---|
| AFP | |||||||||
| (ng/mL) | AFP-L3 | ||||||||
| (ng/mL) | AFP- | ||||||||
| L3% | AFP | ||||||||
| (ng/mL) | AFP-L3 | ||||||||
| (ng/mL) | AFP- | ||||||||
| L3% | AFP | ||||||||
| (ng/mL) | AFP-L3 | ||||||||
| (ng/mL) | AFP- | ||||||||
| L3% | |||||||||
| Total Mean | 33.1 | 8.4 | 25.4 | 506.5 | 117.9 | 23.3 | 175.3 | 126 | 71.8 |
| Within-run SD | 0.50 | 0.38 | 1.01 | 8.89 | 7.98 | 1.29 | 2.90 | 2.7 | 0.73 |
| Within-run CV (%) | 1.5 | 4.5 | 4.0 | 1.8 | 6.8 | 5.5 | 1.7 | 2.1 | 1.0 |
| Day-to-Day SD | 1.14 | 0.29 | 0.55 | 12.72 | 3.44 | 0.53 | 2.86 | 2.67 | 0.70 |
| Day-to-Day CV (%) | 3.4 | 3.5 | 2.2 | 2.5 | 2.9 | 2.3 | 1.6 | 2.1 | 1.0 |
| Run-to-Run SD | 1.42 | 0.66 | 1.15 | 10.76 | 3.69 | 0.67 | 5.46 | 6.36 | 1.62 |
| Run-to-Run CV (%) | 4.3 | 7.9 | 4.5 | 2.1 | 3.1 | 2.9 | 3.1 | 5.0 | 2.3 |
| Total SD | 1.89 | 0.81 | 1.63 | 18.88 | 9.44 | 1.55 | 6.81 | 7.41 | 1.91 |
| Total CV (%) | 5.7 | 9.6 | 6.4 | 3.7 | 8.0 | 6.7 | 3.9 | 5.9 | 2.7 |
Reproducibility - Within-run precision studies were performed by 3 clinical laboratories using two samples with different concentrations of AFP and AFP-L3. The samples were assayed in 21 replicates each run for two runs. Percent CV for AFP and AFP-L3 ranged from 1.0% to 3.9% and 1.5% to 6.9% respectively.
Recovery - Five different concentrations of AFP [(48.6, 118.8, 288.4, 436.1 and 699.0 ng/mL) containing AFP-L3 concentrations of 9.9, 90.5, 42.4, 137.4 and 290.8 ng/mL and calculated AFP-L3% of 20.3, 76.2, 14.7, 31.5 and 41.6%] were spiked into aliquots of 3 serum samples with endogenous AFP concentrations of 15.4, 44.2 and 148.6 ng/mL [containing AFP-L3 concentrations of 0.4, 29.4 and 7.7 ng/mL]. Percent recovery for AFP and AFP-L3 ranged from 95.1% to 108.4% and 95.3% to 118.2% respectively.
b. Linearity/assay reportable range: The assay measuring range is 0.8 ng/mL to 1000 ng/mL
Linearity was evaluated according to CLSI Guideline EP6-A. For AFP, a pool serum sample was spiked with AFP-L1 and AFP-L3
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to achieve two samples, one with approximately 25% and the other 80% AFP-L3. These two samples were serially diluted with saline. Each of the seven dilutions was assayed in five replicates in two runs. For AFP-L3, three samples (50 ng/mL, 200 ng/mL and 900 ng/mL AFP-L1 and AFP-L3) were mixed in various proportions with three low AFP-L3 samples. Each sample was assayed in five replicates in two runs. The assay is linear up to 1000 ng/mL AFP.
Linearity studies were also performed in 3 clinical sites. Thirteen samples with same AFP-L3% but total AFP concentrations covering the assay linear range (0-1000 ng/mL) were analyzed in quadruplicates and for two runs. Eleven samples with same total AFP concentration but AFP-L3% covering the assay linear range (0-100%) were similarly assayed. Results for all three sites are summarized below.
Total AFP
| Site 1 | Site 2 | Site 3 | ||||
|---|---|---|---|---|---|---|
| Run 1 | Run 2 | Run 1 | Run 2 | Run 1 | Run 2 | |
| Slope | 1.0074 | 1.0067 | 1.0031 | 1.0144 | 0.9921 | 0.9888 |
| Intercept | -6.2226 | -3.1165 | -3.5117 | -2.3976 | -5.6467 | -2.8759 |
| R2 | 0.9988 | 0.9997 | 0.9994 | 0.9992 | 0.9974 | 0.9997 |
AFP-L3%
| Site 1 | Site 2 | Site 3 | ||||
|---|---|---|---|---|---|---|
| Run 1 | Run 2 | Run 1 | Run 2 | Run 1 | Run 2 | |
| Slope | 1.0494 | 0.9958 | 0.9942 | 0.9933 | 0.9946 | 0.9992 |
| Intercept | 3.8505 | -0.7228 | 0.3529 | -0.3858 | -1.3065 | -1.1302 |
| R2 | 0.9835 | 0.9995 | 0.9999 | 0.9996 | 0.998 | 0.9992 |
Traceability (controls, calibrators, or method): C.
The 1st International standard for AFP from WHO was used to assign values to the calibrators and controls.
The primary standards for calibrator 1 and 2 are prepared by diluting purified AFP-L1 and AFP-L3 respectively. Values are assigned using the WHO AFP standard. The primary standards are then used as calibrators to assign values to bulk preparations of AFP-L1 and AFP-L2 by assaying on four LiBASys instruments together with a previous lot of calibrators. If the bulk preparations meet the established acceptance criteria, the solutions are subdivided. One vial is selected from each of the new lot of calibrators for product testing with a previous lot of calibrators and using the primary standards for calibration. AFP values of the new lot are calculated from the mean results of both bulk and product tests. The AFP-L3% of calibrator 1 is assigned 0% and that of calibrator 2 is assigned as 100%.
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The two AFP-L3 controls are prepared by mixing purified AFP-L1 and AFP-L3 and assayed on 5 LiBASys instruments using the primary standards 1 and 2 for calibration and compared to previous lot of AFP-L3 control set. Procedures for value assignment and product testing are similar to that described for calibrators.
d. Detection limit (functional sensitivity):
The minimal detectable concentration (MDC) for AFP was determined by assaying 21 replicates of a deionized water sample and is defined as mean concentration of AFP +2SD. Data showed the mean AFP concentration was 0.14 ng/mL with a SD of 0.06 ng/mL. The MDC was therefore 0.26 ng/mL. The analytical sensitivity claim is 0.8 ng/mL.
Functional sensitivity was determined by assaying 11 serum samples with AFP-L1 and AFP-L3 concentrations between 0 and 65 ng/mL. For each concentration, 8 replicates were run and the percents CV obtained of the replicates were plotted against the respective AFP-L1 or L3 concentrations. Functional sensitivity was established to be 10 ng/mL.
e. Analytical specificity:
Interference was determined by spiking different concentrations of each interfering substance into aliquots of a low and a high AFP serum sample. The AFP samples were prepared by spiking in AFP-L1 and L-3 into a pooled serum. The interfering substances tested include hemoglobin (0-1000 mg/dL), free bilirubin (0-40 mg/dL), conjugated bilirubin (0-30 mg/dL), intrafat (0-2%), rheumatoid factor (0-550 IU/mL), glucose (0-1000 mg/dL), galactose (0-200 mg/dL) and ascorbate (0-50 mg/dL). Glucose concentration >600 mg/dL can result in decreased AFP-L3%. Decreased AFP-L3% results were also observed for free and conjugated bilirubins >20 mg/dL (this information is in the package insert).
Drug interference was determined by additive studies of vitamins B1, B6 and B12, interferons (IFN) a, B and y, ibuprofen, acetaminophen and acetylsalicylic acid. Results of AFP and AFP-L3% were not affected by Vitamins B1 (14 mg/dL), B6 (25 mg/dL), B12 (50 mg/dL), IFN-α (3,000 units/mL), IFN-β (3,000 units/mL), IFN-y (3,000 JRU/mL), Ibuprofen (40 mg/dL), acetaminophen (20 mg/dL) and acetylsalicylic acid (50 mg/dL). Percent recoveries ranged from 95.2% to 105.6%.
HAMA interference - Four different concentrations of AFP [(19.4 ng/mL, 71.1 ng/mL, 238.1 ng/mL and 297.5 ng/mL) containing
6
AFP-L3 concentrations of 3.7, 58.3, 84.5 and 51.5 ng/mL] were spiked into aliquots of a positive HAMA serum sample. Each AFP concentration was assayed in quadruplicate and percent recoveries were determined for AFP, AFP-L3 and AFP-L3%. Percent recoveries ranged from 94.5% to 100.1% for AFP, 95% to 112.8% for AFP-L3 and 97.9% to 113.5% for AFP-L3%.
- f. Assay cut-off:
AFP-L3% is not reported if total AFP is 400-500 ng/mL alone, 5) at least 3 serial blood draws that showed a rising serum AFP in the setting of a liver mass or 6) a mass on CT
7
scan that enhances in the arterial phase and was hypoattentuating compared to the rest of the liver in the venous phase.
The objective of the study was to observe a minimum of 30 subjects who developed verifiable HCC during the study. At the end of the study, all evaluable subjects without HCC at enrollment were categorized by the physician investigators based on biopsy, explanted liver histology, imaging results and site policies into three groups: 1) developed confirmed HCC during study and with lesions of at least 0.5 cm in diameter; 2) suspected of possibly HCC with lesions at least 0.3 cm in diameter and high total AFP results and 3) did not have HCC but had complete workup. Data were collected on study subjects for the duration of the study (approximately 3 years) or until death, developed HCC or end of study. Evaluable patients were defined as patients who had at least one valid AFP-L3% result.
In the data analysis, the number of days was calculated for each patient as the time between the first AFP-L3% ≥ 10 and the confirmed HCC diagnosis for group 2 patients and for the other groups, the AFP-L3 % value between study enrollment and end of study was used. The primary endpoint is the relative risk (with 95% CI) of developing HCC within the next 21 months in patients with AFP-L3% ≥10% as compared to the risk in patients with AFPL3% 10% considered positive for HCC.
-
- Expected values/Reference range:
Expected value range for AFP in healthy adults is 0.1 to 5.8 ng/mL according to published literature (Masseyeff R., et al. N. Engl. J. Med. 291 (1974), 532). Normal reference value for AFP-L3% is not detectable.
- Expected values/Reference range:
N. Instrument Name:
Wako LiBASys
O. System Descriptions:
-
- Device Description:
The LiBASys consists of a main analyzer, a bar code reader and a drain port. The main analyzer contains the following units: analysis, reaction, solution feed, column setup, photometric, display operation, elution accommodation, tank accommodation and power.
- Device Description:
-
- Principles of Operation: See Test Principles
-
- Modes of Operation: Automated fluorescence analyzer
-
Software: ধ FDA has reviewed applicant's Hazard Analysis and software development processes for this line of product types: Yes
-
રું છ Specimen Identification: Bar-coding of the serum samples is done before the samples are loaded into the instrument
13
-
- Specimen Sampling and Handling:
Serum samples are to be assayed immediately after blood collection. If not, store samples at -80°C. Patient serum samples are put into sample cups which are loaded into the sample disk housed in the analysis unit with the reaction disk.
- Specimen Sampling and Handling:
-
- Assay Types:
Liquid binding assay using anion column separation of immune complexes.
- Assay Types:
-
- Reaction Types: Rate assay.
-
- Calibration:
A two-point linear calibration is required every assay run.
-
- Quality Control: Two level controls are used. Values should be within ±15% of assigned values.
- P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above: None.
- Q. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
- R. Conclusion:
The petition for Evaluation of Automatic Class III Designation for this device is accepted. The device is classified as Class II under regulation 21 CFR 866.6030 with special controls. The special control guidance document "AFP-L3% Immunological Test System" is available at WWW.fda.gov/cdrh/oivd/guidance/1570.pdf