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510(k) Data Aggregation
K Number
K191562Manufacturer
Date Cleared
2020-03-06
(267 days)
Regulation Number
866.5340Type
TraditionalPanel
ImmunologyWhy did this record match?
Device Name :
Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Yumizen C1200 Ferritin reagent is intended for the quantitative in vitro diagnostic determination of Ferritin in human serum by latex-enhanced immunoturbidimetric assay. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, hemochromatosis (iron overload) and iron deficiency anemia.
Yumizen C1200 Transferrin reagent is intended for the quantitative in vitro diagnostic determination of transferrin in human serum and lithium heparin plasma by turbidimetry.
Measurement of transferrin levels ads in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia.
Yumizen C1200 Rheumatoid Factor reagent is intended for the quantitative in vitro diagnostic determination of rheumatoid factor in human serum by latex-enhanced immunoturbidimetric assay. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.
Device Description
Not Found
AI/ML Overview
The document describes the analytical performance characteristics of three devices: Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, and Yumizen C1200 Rheumatoid Factor. Each device is intended for the quantitative in vitro diagnostic determination of specific substances in human serum, and sometimes plasma, using immunoturbidimetric or turbidimetric assays.
Here's an analysis of the acceptance criteria and study details for each device:
Yumizen C1200 Ferritin
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Measuring Range (Serum) | N/A (claimed measuring range is appropriate based on LOD, LOQ, and linearity studies) | 10 to 450 ng/mL |
| Limit of Detection (Serum) | N/A (determined according to CLSI EP17-A2) | 6.30 ng/mL |
| Limit of Quantitation (Serum) | N/A (determined according to CLSI EP17-A2) | 9.39 ng/mL |
| Linearity (Serum) | N/A (determined according to CLSI EP06-A) | Evaluated from 13.3 to 426.6 ng/mL (appropriate) |
| Total Precision (Analyzer Variability) - Within Run CV | Low level: ≤ 8.0% | |
| Middle level: ≤ 6.0% | ||
| High level: ≤ 6.0% | Level 1 Control (47.58 ng/mL): 3.6% | |
| Level 2 Control (279.31 ng/mL): 1.1% | ||
| Sample 1 (29.56 ng/mL): 5.5% | ||
| Sample 2 (50.87 ng/mL): 4.1% | ||
| Sample 3 (172.63 ng/mL): 1.4% | ||
| Sample 4 (328.60 ng/mL): 1.3% | ||
| Sample 5 (403.21 ng/mL): 1.0% | ||
| Total Precision (Analyzer Variability) - Total CV | Low level: ≤ 10.0% | |
| Middle & High level: ≤ 8.0% | Level 1 Control: 4.9% | |
| Level 2 Control: 2.1% | ||
| Sample 1: 7.9% | ||
| Sample 2: 5.1% | ||
| Sample 3: 1.9% | ||
| Sample 4: 4.3% | ||
| Sample 5: 1.4% | ||
| Total Precision (Lot to Lot Variability) - Within Run CV | Low level: ≤ 8.0% | |
| Middle level: ≤ 6.0% | ||
| High level: ≤ 6.0% | Level 1 Control (52.84 ng/mL): 4.6% | |
| Level 2 Control (281.87 ng/mL): 0.9% | ||
| Sample 1 (19.09 ng/mL): 8.8% | ||
| Sample 2 (34.05 ng/mL): 6.5% | ||
| Sample 3 (51.53 ng/mL): 3.6% | ||
| Sample 4 (192.31 ng/mL): 1.4% | ||
| Sample 5 (407.38 ng/mL): 0.9% | ||
| Total Precision (Lot to Lot Variability) - Total CV | Low level: ≤ 10.0% | |
| Middle & High level: ≤ 8.0% | Level 1 Control: 6.4% | |
| Level 2 Control: 1.6% | ||
| Sample 1: 11.8% (above criterion, but "pvalue with 5% acceptable remains acceptable") | ||
| Sample 2: 6.5% | ||
| Sample 3: 3.8% | ||
| Sample 4: 2.8% | ||
| Sample 5: 1.4% | ||
| Interferences (Bias) | +/- 10% of value without interfering substances | Hemoglobin: up to 500 mg/dL |
| Triglycerides: up to 270.42 mg/dL | ||
| Total Bilirubin: up to 29.5 mg/dL | ||
| Direct Bilirubin: up to 25.87 mg/dL | ||
| Ascorbic Acid: up to 5.98 mg/dL | ||
| Others specified in document | ||
| Prozone / Antigen Excess Effect | Detect and flag samples with underestimated results due to high concentration | Antigen excess observed > 5043 ng/mL; an alarm will flag and re-run these samples. |
| Method Comparison (Correlation with Predicate) | N/A (determined acceptable by high correlation) | Correlation (r²) = 0.999 (for 103 samples, 16.74 - 413.00 ng/mL range) |
| Closed Stability | N/A (defined by statement) | 18 months, stored at 2-10°C, protected from light. |
| Open Stability (On-board) | N/A (defined by statement) | 2 months |
| Reference Range Verification | Support establishing ranges vs. literature | Women: 10 - 120 ng/ml (µg/l) |
| Men: 20 - 250 ng/ml (µg/l) |
2. Sample Size and Data Provenance (for test set)
- Measuring Range, Precision, Interferences, Prozone/Antigen Excess: Not explicitly stated as "test set" in the context of supervised learning, but these are analytical performance studies. Samples used for precision studies include 240 replicates for analyzer variability and 90 replicates for lot-to-lot variability (for each sample/control). The samples are clinical samples or controls, but the origin (country, retrospective/prospective) is not specified beyond "human serum specimens".
- Method Comparison: 103 native sera samples. Origin: "Anonymous remnants of human serum specimens collected from blood bank." Retrospective.
- Reference Range: Women: 50 "normal samples". Men: 95 "normal samples". Origin: "blood bank." Retrospective.
3. Number of experts and qualifications (for ground truth)
- Not applicable as this is an in vitro diagnostic device for quantitative measurement, not an AI evaluation requiring expert adjudication. Ground truth is instrument-derived or defined by reference methods/literature.
4. Adjudication method (for test set)
- Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study
- No, not applicable for this type of IVD device.
6. Standalone performance (algorithm only)
- Yes, the performance data presented is for the device operating in standalone mode (algorithm only) as a quantitative measurement system.
7. Type of ground truth used
- Analytical Performance (LOD, LOQ, Linearity, Precision, Interferences, Prozone/Antigen Excess): The "ground truth" is established through well-defined laboratory analytical methods and standards (CLSI guidelines EP17-A2, EP06-A, EP05-A3, EP07-A2). It relies on the accuracy of the reference materials and methods used in these studies.
- Method Comparison: Comparison against a legally marketed predicate device (Beckman Coulter Ferritin (OSR61203) [K092505]) is used as the reference, with correlation analysis.
- Reference Range: Verification against established literature references (e.g., TIETZ Textbook of Clinical Chemistry and Molecular Diagnostics).
8. Sample size for the training set
- Not applicable. This is not a machine learning model that requires a "training set" in that sense. The device's calibration curve establishment and internal parameters would be set by the manufacturer using validated reference materials and methodologies.
9. How the ground truth for the training set was established
- Not applicable.
Yumizen C1200 Transferrin
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Measuring Range (Serum/Plasma) | N/A (claimed measuring range is appropriate based on LOD, LOQ, and linearity studies) | 0.10 to 5.20 g/L |
| Limit of Detection (Serum/Plasma) | N/A (determined according to CLSI EP17-A2) | 0.002 g/L |
| Limit of Quantitation (Serum/Plasma) | N/A (determined according to CLSI EP17-A2) | 0.07 g/L |
| Linearity (Serum/Plasma) | N/A (determined according to CLSI EP06-A) | Evaluated from 0.15 to 4.61 g/L (appropriate) |
| Total Precision (Analyzer Variability) - Within Run CV | Low level: ≤ 6.0% | |
| Middle level: ≤ 4.5% | ||
| High level: ≤ 3.8% | Level 1 Control (1.24 g/L): 1.2% | |
| Level 2 Control (3.35 g/L): 1.5% | ||
| Sample 1 (0.78 g/L): 1.0% | ||
| Sample 2 (1.02 g/L): 1.2% | ||
| Sample 3 (1.83 g/L): 1.3% | ||
| Sample 4 (3.78 g/L): 1.5% | ||
| Total Precision (Analyzer Variability) - Total CV | Low level: ≤ 8.0% | |
| Middle & High level: ≤ 6.0% | Level 1 Control: 3.6% | |
| Level 2 Control: 3.6% | ||
| Sample 1: 4.5% | ||
| Sample 2: 3.2% | ||
| Sample 3: 2.3% | ||
| Sample 4: 2.7% | ||
| Total Precision (Lot to Lot Variability) - Within Run CV | Low level: ≤ 6.0% | |
| Middle level: ≤ 4.5% | ||
| High level: ≤ 3.8% | Level 1 Control (1.29 g/L): 3.5% | |
| Level 2 Control (3.41 g/L): 1.7% | ||
| Sample 1 (0.77 g/L): 4.2% | ||
| Sample 2 (1.08 g/L): 1.5% | ||
| Sample 3 (1.96 g/L): 1.3% | ||
| Sample 4 (3.54 g/L): 2.6% | ||
| Total Precision (Lot to Lot Variability) - Total CV | Low level: ≤ 8.0% | |
| Middle & High level: ≤ 6.0% | Level 1 Control: 6.6% | |
| Level 2 Control: 3.0% | ||
| Sample 1: 5.4% | ||
| Sample 2: 3.3% | ||
| Sample 3: 3.4% | ||
| Sample 4: 3.4% | ||
| Interferences (Bias) | +/- 10% of value without interfering substances | Hemoglobin: up to 500 mg/dL |
| Triglycerides: up to 353.28 mg/dL | ||
| Total Bilirubin: up to 43.84 mg/dL | ||
| Direct Bilirubin: up to 23.86 mg/dL | ||
| Ascorbic Acid: up to 5.98 mg/dL | ||
| Others specified in document | ||
| Anticoagulant Study (Serum vs. Heparin Plasma) | No significant difference between serum and plasma | Correlation (r) = 0.995, Intercept = 0.04833, Slope = 0.9691 (59 paired samples) |
| Prozone / Antigen Excess Effect | No antigen excess detected within claimed range | No antigen excess detected up to 40 g/L. |
| Method Comparison (Correlation with Predicate) | N/A (determined acceptable by high correlation) | Correlation (r²) = 0.993 (for 115 samples, 0.37 - 4.81 g/L range) |
| Closed Stability | N/A (defined by statement) | 24 months, stored at 2-8°C, protected from light. |
| Open Stability (On-board) | N/A (defined by statement) | 6 weeks |
| Reference Range Verification | Support establishing ranges vs. literature | Normal range Transferrin - Serum: 2 - 3.6 g/l (200 - 360 mg/dl) |
2. Sample Size and Data Provenance (for test set)
- Measuring Range, Precision, Interferences, Prozone/Antigen Excess: Not explicitly stated as "test set" in the context of supervised learning, but these are analytical performance studies. Samples used for precision studies include 240 replicates for analyzer variability and 90 replicates for lot-to-lot variability (for each sample/control). The samples are clinical samples or controls, but the origin (country, retrospective/prospective) is not specified beyond "human serum/plasma".
- Method Comparison: 115 native samples. Origin: "Anonymous remnants of human serum specimens collected from CHU Nîmes (University Hospital Center)." Retrospective.
- Anticoagulant Study: 59 paired serum/plasma samples. Origin: "single donors." Not specified if retrospective or prospective.
- Reference Range: 85 "normal samples" (28 women + 57 men). Origin: "blood bank." Retrospective.
3. Number of experts and qualifications (for ground truth)
- Not applicable.
4. Adjudication method (for test set)
- Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study
- No, not applicable.
6. Standalone performance (algorithm only)
- Yes, the performance data presented is for the device operating in standalone mode (algorithm only).
7. Type of ground truth used
- Analytical Performance: Established through CLSI guidelines (EP17-A2, EP06-A, EP05-A3, EP07-A2).
- Method Comparison: Comparison against a legally marketed predicate device (Roche Diagnostics Transferrin Model :TRSF2 [K012393]).
- Reference Range: Verification against established literature references (e.g., Dati et al., Eur. J Clin Chem. Cli Biochem. 1996).
8. Sample size for the training set
- Not applicable.
9. How the ground truth for the training set was established
- Not applicable.
Yumizen C1200 Rheumatoid Factor
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Measuring Range (Serum) | N/A (claimed measuring range is appropriate based on LOD, LOQ, and linearity studies) | 10 to 120 IU/mL |
| Limit of Detection (Serum) | N/A (determined according to CLSI EP17-A2) | 4.07 IU/mL |
| Limit of Quantitation (Serum) | N/A (determined according to CLSI EP17-A2) | 7.41 IU/mL |
| Linearity (Serum) | N/A (determined according to CLSI EP06-A) | Evaluated from 13.2 to 118.8 IU/mL (appropriate) |
| Total Precision (Analyzer Variability) - Within Run CV | Low level: ≤ 6.0% | |
| Middle level: ≤ 4.5% | ||
| High level: ≤ 3.8% | Level 1 Control (40.99 IU/mL): 0.5% | |
| Level 2 Control (63.93 IU/mL): 0.4% | ||
| Sample 1 (22.24 IU/mL): 1.2% | ||
| Sample 2 (34.28 IU/mL): 0.8% | ||
| Sample 3 (49.41 IU/mL): 0.5% | ||
| Sample 4 (70.16 IU/mL): 0.5% | ||
| Sample 5 (103.42 IU/mL): 0.8% | ||
| Total Precision (Analyzer Variability) - Total CV | Low level: ≤ 8.0% | |
| Middle & High level: ≤ 6.0% | Level 1 Control: 2.2% | |
| Level 2 Control: 2.5% | ||
| Sample 1: 2.0% | ||
| Sample 2: 2.2% | ||
| Sample 3: 1.8% | ||
| Sample 4: 1.6% | ||
| Sample 5: 1.4% | ||
| Total Precision (Lot to Lot Variability) - Within Run CV | Low level: ≤ 6.0% | |
| Middle level: ≤ 4.5% | ||
| High level: ≤ 3.8% | Level 1 Control (41.70 IU/mL): 1.8% | |
| Level 2 Control (67.05 IU/mL): 1.4% | ||
| Sample 1 (17.30 IU/mL): 2.9% | ||
| Sample 2 (30.88 IU/mL): 1.4% | ||
| Sample 3 (53.08 IU/mL): 1.4% | ||
| Sample 4 (70.24 IU/mL): 1.1% | ||
| Sample 5 (102.14 IU/mL): 1.0% | ||
| Total Precision (Lot to Lot Variability) - Total CV | Low level: ≤ 8.0% | |
| Middle & High level: ≤ 6.0% | Level 1 Control: 1.9% | |
| Level 2 Control: 2.2% | ||
| Sample 1: 3.1% | ||
| Sample 2: 1.8% | ||
| Sample 3: 3.2% | ||
| Sample 4: 1.3% | ||
| Sample 5: 1.8% | ||
| Interferences (Bias) | +/- 10% of value without interfering substances | Hemoglobin: up to 500 mg/dL |
| Triglycerides: up to 526.75 mg/dL | ||
| Total Bilirubin: up to 31.32 mg/dL | ||
| Direct Bilirubin: up to 25.34 mg/dL | ||
| Ascorbic Acid: up to 5.98 mg/dL | ||
| Others specified in document | ||
| Prozone / Antigen Excess Effect | Detect and flag samples with underestimated results due to high concentration | Antigen excess observed > 229 IU/mL; an alarm will flag and re-run these samples. |
| Method Comparison (Correlation with Predicate) | N/A (determined acceptable by high correlation) | Correlation (r²) = 0.992 (for 113 samples, 16.79 - 118.81 IU/mL range) |
| Closed Stability | N/A (defined by statement) | 18 months, stored at 2-10°C. |
| Open Stability (On-board) | N/A (defined by statement) | 1 month |
| Reference Range Verification | Support establishing ranges vs. literature | Normal range Rheumatoid Factor: Adult |
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