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510(k) Data Aggregation
(382 days)
Transferrin
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I am sorry, but the provided text is a standard FDA clearance letter and does not contain information about the acceptance criteria, study details, or performance of the "Transferrin" device mentioned. The letter confirms that the device is substantially equivalent to a predicate device and can be marketed, but it does not include the technical or clinical study data.
To answer your request, I would need a document that describes the actual performance study and its results.
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(267 days)
Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
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.
Not Found
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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(94 days)
Tina-quant Transferrin ver.2 (urine application)
Tina-quant Transferrin ver.2 (urine application) assay is an in vitro test for the quantitative determination of transferrin in human urine on Roche/Hitachi cobas c systems.
A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in urine. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.
The Tina-quant Transferrin ver.2 (urine application) assay is a two reagent assay for the in vitro quantitative determination of transferrin in human urine on automated clinical chemistry analyzers. It is an immunoturbidimetric assay in which human transferrin forms a precipitate with a specific antiserum which is determined turbidimetrically.
Engineering drawings, schematics, and figures are not pertinent to describe the device, as the device is a reagent.
The document provided is a 510(k) Premarket Notification for an in vitro diagnostic device, the "Tina-quant Transferrin ver.2 (urine application) assay." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving clinical effectiveness through extensive human studies often seen with novel medical devices. Therefore, the information regarding acceptance criteria and study design will be primarily focused on analytical performance validation rather than multi-reader multi-case clinical studies involving human interpretation of images, as this is a laboratory reagent.
Here's an analysis of the provided text in the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are largely implicit in the fact that "All data passed the predetermined acceptance criteria" for each analytical study. The performance is reported as the results of these studies.
| Performance Characteristic | Acceptance Criteria (Implicit: "All data passed the predetermined criteria") | Reported Device Performance |
|---|---|---|
| Precision | CV% and SD values within predefined limits. | Repeatability (within-run precision) |
| - PreciControl ClinChem Multi 1 | Not explicitly stated, but results passed. | Mean: 1.98 mg/dL, SD: 0.0140 mg/dL, CV: 0.7% |
| - PreciControl ClinChem Multi 2 | Not explicitly stated, but results passed. | Mean: 3.05 mg/dL, SD: 0.0242 mg/dL, CV: 0.8% |
| - Human Urine 1 | Not explicitly stated, but results passed. | Mean: 0.435 mg/dL, SD: 0.00979 mg/dL, CV: 2.3% |
| - Human Urine 2 | Not explicitly stated, but results passed. | Mean: 0.737 mg/dL, SD: 0.00920 mg/dL, CV: 1.2% |
| - Human Urine 3 | Not explicitly stated, but results passed. | Mean: 1.27 mg/dL, SD: 0.0107 mg/dL, CV: 0.8% |
| - Human Urine 4 | Not explicitly stated, but results passed. | Mean: 2.52 mg/dL, SD: 0.0184 mg/dL, CV: 0.7% |
| - Human Urine 5 | Not explicitly stated, but results passed. | Mean: 3.30 mg/dL, SD: 0.0252 mg/dL, CV: 0.8% |
| Intermediate Precision (within-lab precision) | Not explicitly stated, but results passed. | |
| - PreciControl ClinChem Multi 1 | Not explicitly stated, but results passed. | Mean: 1.98 mg/dL, SD: 0.0158 mg/dL, CV: 0.8% |
| - PreciControl ClinChem Multi 2 | Not explicitly stated, but results passed. | Mean: 3.05 mg/dL, SD: 0.0267 mg/dL, CV: 0.9% |
| - Human Urine 1 | Not explicitly stated, but results passed. | Mean: 0.435 mg/dL, SD: 0.0111 mg/dL, CV: 2.5% |
| - Human Urine 2 | Not explicitly stated, but results passed. | Mean: 0.737 mg/dL, SD: 0.0112 mg/dL, CV: 1.5% |
| - Human Urine 3 | Not explicitly stated, but results passed. | Mean: 1.23 mg/dL, SD: 0.0130 mg/dL, CV: 1.1% |
| - Human Urine 4 | Not explicitly stated, but results passed. | Mean: 2.52 mg/dL, SD: 0.0215 mg/dL, CV: 0.9% |
| - Human Urine 5 | Not explicitly stated, but results passed. | Mean: 3.30 mg/dL, SD: 0.0289 mg/dL, CV: 0.9% |
| Analytical Sensitivity | ||
| - Limit of Blank (LoB) | LoB Claim: 0.10 mg/dL (highest measurement for blank sample with stated prob.) | Lot #1: 0.0150 mg/dL, Lot #2: 0.0130 mg/dL, Lot #3: 0.0150 mg/dL |
| - Limit of Detection (LoD) | LoD Claim: 0.15 mg/dL (lowest detectable analyte concentration with 95% prob.) | Lot #1: 0.0382 mg/dL, Lot #2: 0.0331 mg/dL, Lot #3: 0.0353 mg/dL |
| - Limit of Quantitation (LoQ) | LoQ Claim: 0.22 mg/dL with 20% CV (lowest quantifiable concentration) | Lot #1: 0.124 mg/dL, Lot #2: 0.137 mg/dL, Lot #3: 0.143 mg/dL |
| Linearity/Assay Reportable Range | Linear relationship across the measuring range. | |
| - Measuring Range Claim | 0.22 to 3.5 mg/dL. | Confirmed. |
| - Pearson Correlation Coefficient (r) | Close to 1. | Lot 1: 0.9999, Lot 2: 0.9999, Lot 3: 0.9997 |
| Endogenous Interferences | No interference at specified concentrations. | |
| - Albumin | No interference ≤ 5000 mg/L. | Passed (tested at 5 g/L). |
| - Calcium | No interference ≤ 8 mmol/L. | Passed (tested up to 9.92/9.80 mmol/L). |
| - Citrate | No interference ≤ 10 mmol/L. | Passed (tested up to 11 mmol/L). |
| - Creatinine | No interference ≤ 44 mmol/L. | Passed (tested up to 88 mmol/L). |
| - Glucose | No interference ≤ 111 mmol/L. | Passed (tested up to 388 mmol/L). |
| - Hemoglobin | No significant interference up to 100 mg/dL. | Passed (tested up to 146/149 mg/dL). |
| - Immunoglobulin (IgG) | No interference ≤ 500 mg/L. | Passed (tested up to 1.1 g/L). |
| - Magnesium | No interference ≤ 75 mmol/L. | Passed (tested up to 75 mmol/L). |
| - Oxalate | No interference ≤ 2.2 mmol/L. | Passed (tested up to 3.75 mmol/L). |
| - Phosphate | No interference ≤ 40 mmol/L. | Passed (tested up to 130 mmol/L). |
| - Urea | No interference ≤ 1000 mmol/L. | Passed (tested up to 1500/1800 mmol/L). |
| - Uric Acid | No interference ≤ 6 mmol/L. | Passed (tested up to 6 mmol/L). |
| - Urobilinogen | No interference ≤ 15 mg/dL. | Passed (tested up to 15 mg/dL). |
| Exogenous Interferences – Drugs | No interference at therapeutic concentrations (except noted). | |
| - Acetaminophen | Not explicitly stated, but results passed up to 3000 mg/L. | No interference up to 3000 mg/L. |
| - Ascorbic acid | Not explicitly stated, but results passed up to 4000 mg/L. | No interference up to 4000 mg/L. |
| - Cefoxitin | Not explicitly stated, but results passed up to 12000 mg/L. | No interference up to 12000 mg/L. |
| - Gentamicin sulfate | Not explicitly stated, but results passed up to 400 mg/L. | No interference up to 400 mg/L. |
| - Ibuprofen | Not explicitly stated, but results passed up to 500 mg/L. | No interference up to 500 mg/L. |
| - Levodopa | Not explicitly stated, but results passed up to 1000 mg/L. | No interference up to 1000 mg/L. |
| - Methyldopa | Not explicitly stated, but results passed up to 2000 mg/L. | No interference up to 2000 mg/L. |
| - N-Acetylcysteine | Not explicitly stated, but results passed up to 10 mg/L. | No interference up to 10 mg/L. |
| - Ofloxacine | No interference. | Interference observed (artificially high results). Claim adjusted. |
| - Phenazopyridine | Not explicitly stated, but results passed up to 50 mg/L. | No interference up to 50 mg/L. |
| - Salicyluric acid | Not explicitly stated, but results passed up to 100 mg/L. | No interference up to 100 mg/L. |
| - Tetracycline | Not explicitly stated, but results passed up to 300 mg/L. | No interference up to 300 mg/L. |
| Method Comparison to Predicate | Predetermined acceptance criteria met. (e.g. slope near 1, intercept near 0, high r) | y = 1.007x + 0.0052, r = 0.995 (Passing Bablok Regression) |
2. Sample Size Used for the Test Set and Data Provenance
- Precision and Analytical Sensitivity (LoB, LoD, LoQ):
- Precision (Repeatability and Intermediate Precision): 5 human urine sample pools and 2 control samples. Tested for 21 days, 1 run/day, with 2 aliquots per sample in singlicate per part. This setup generates a large number of individual measurements over time to assess variability.
- LoB: One analyte-free sample, measured 10-fold per run across 6 runs (over 4 days) on 3 reagent lots, resulting in 60 measurements per lot.
- LoD: Five human urine samples with low-analyte concentration, measured 2-fold per run across 6 runs (over 4 days) on 3 reagent lots, resulting in 60 measurements per lot.
- LoQ: A low-level sample set prepared by diluting 5 human urine samples, tested in 5 replicates per sample on 4 days, 1 run per day.
- Linearity/Assay Reportable Range: Dilution series prepared using human urine sample pools (number of pools not specified, but likely at least one concentrated pool), with 13 concentrations measured on 3 lots in triplicate.
- Endogenous Interferences: Two human urine pools (at two transferrin concentrations) were used for each interferent. Each pool was divided into two aliquots (spiked with interferent vs. solvent control). A dilution series of 11 steps was prepared and 3 aliquots per level were tested.
- Exogenous Interferences – Drugs: Two human urine sample pools (spiked with approximately 0.433 and 2.48 mg/dL transferrin concentrations) were used for each drug. Each pool was divided into two aliquots (drug spiked vs. solvent control), measured in triplicate.
- Method Comparison to Predicate: One hundred and seven (107) routine fresh, never-frozen human urine samples. Two samples were excluded (pH >8, value outside measuring range), so 107 samples were truly used in the comparison.
- Data Provenance: The document explicitly states "human urine samples" or "human urine sample pools." For the method comparison, samples were "routine fresh, never-frozen human urine samples." There is no specific mention of the country of origin, but Roche Diagnostics Operations (RDO) is located in Indianapolis, Indiana, USA, and Roche Diagnostics GmbH, Mannheim, Germany is also mentioned as having the establishment registration. The studies are prospective analytical validation studies conducted with collected samples, not retrospective analysis of clinical patient data in the typical sense for imaging.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of in vitro diagnostic device (IVD) aims for quantitative measurement of a biomarker. Therefore, the "ground truth" is established through analytical reference methods, certified reference materials, or highly rigorous internal validation processes tied to metrological traceability, rather than human expert consensus on subjective findings (as would be the case for an imaging AI).
- The ground truth for the test set is established by the analytical measurement on the reference method (for method comparison study), and by the known concentrations/dilutions of samples prepared for analytical studies (e.g., linearity, sensitivity, interference).
- No "experts" in the sense of radiologists interpreting images were involved in establishing the ground truth for these analytical performance studies. The accuracy of measurements is verified against the reference standard or predetermined analytical values.
4. Adjudication Method for the Test Set
Not applicable for this type of analytical performance study. Adjudication methods (e.g., 2+1, 3+1) are common in clinical studies where multiple human readers independently assess data (like images) and then a consensus or tie-breaking mechanism is needed to establish ground truth or assess agreement. For an IVD, the "truth" is typically defined by the analytical method itself or a reference method.
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 device is a quantitative laboratory assay (a reagent for measuring transferrin in urine), not an AI imaging algorithm that assists human readers. No MRMC study was performed as it is irrelevant to the device's function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the analytical performance studies (Precision, Analytical Sensitivity, Linearity, Interference, Method Comparison) represent the "standalone" performance of the assay itself (the reagent/instrument system) without human intervention in the result generation beyond operating the analyzer according to instructions. This is the primary form of performance evaluation for an IVD.
7. The Type of Ground Truth Used
- For Precision, Analytical Sensitivity, Linearity, and Interference studies: The ground truth is effectively derived from known concentrations in prepared samples (e.g., analyte-free samples, low-concentration samples, dilution series, spiked samples) or reference materials/controls with established values.
- For Method Comparison: The ground truth is the measurement obtained from the predicate device, the "N Antisera to Human Transferrin (Siemens) on the BN ProSpec analyzer." This establishes substantial equivalence to an already legally marketed device.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires "training data" in the conventional sense. It's a chemical reagent for an established analytical method (immunoturbidimetry). The development process would have involved formulation and optimization, but not "training" on a data set in the way an AI model would be.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of IVD, which relies on chemical and immunological principles rather than machine learning from data.
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(384 days)
TRANSFERRIN KIT FOR USE ON THE SPAPLUS
The Binding Site Human Transferrin Kit is intended for the quantitative determination of human transferrin using the Binding Site SPAPLus turbidimetric analyzer in human serum. The measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection and iron deficiency anemia. This test should be used in conjunction with other laboratory and clinical findings
Not Found
The provided document is a 510(k) clearance letter from the FDA for a diagnostic kit, specifically "Human Transferrin kit for use on the SPAPlus™". This type of document primarily confirms that a new device is substantially equivalent to a legally marketed predicate device, and it typically does not include detailed study reports with specific acceptance criteria, performance data, or details about training and test sets in the way that would be provided for an AI/ML medical device submission.
The information requested in the prompt (acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) is characteristic of the rigorous clinical validation studies required for AI/ML devices, not typically for a traditional in vitro diagnostic kit like the one described here.
Therefore, I cannot extract the requested information from the provided text because the document does not contain details about:
- A table of acceptance criteria and reported device performance in the context of an AI/ML device. The "performance" mentioned for this kit would usually refer to analytical performance characteristics (e.g., accuracy, precision, linearity) which are not detailed here.
- Sample sizes for test sets or data provenance.
- Number of experts or their qualifications.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone performance (as it's not an AI/ML algorithm).
- Type of ground truth used (beyond implying the "gold standard" for transferrin measurement).
- Sample size for training sets.
- How ground truth for training was established.
The document is a regulatory approval letter, specifically stating the device's substantial equivalence and its intended use for the quantitative determination of human transferrin to aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia using the Binding Site SPAPlus™ turbidimetric analyzer.
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(302 days)
TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS
The transferrin test system is intended for the quantitative in-vitro diagnostic determination of transferrin in serum or plasma using T60 Clinical chemistry Analyzers. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, acute infection and iron deficiency anemia.
SpeciCal protein calibrator is used as a stock calibrator for both quantification of specific proteins in serum and plasma by immunoturbidimetry and for antigen excess detection using methods defined by Thermo Electron Oy
SpeciTrol is intended to be used as an assayed control serum to monitor precision of specific protein tests defined by Thermo Electron Ov
Specitrol High is intended to be used as an assayed control serum to monitor precision of specific protein tests defined by Thermo Electron Oy
Not Found
The provided text does not contain detailed information about the acceptance criteria or a study that proves the device meets those criteria. The document is primarily a 510(k) clearance letter from the FDA for a device named "Transferrin, Specical Calibrator, Specitrol Control and Specitrol High Control."
The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. However, it does not include:
- A table of acceptance criteria and reported device performance.
- Information on sample sizes used for test sets, data provenance (country, retrospective/prospective).
- Details about the number or qualifications of experts used to establish ground truth.
- Adjudication methods.
- Results from a multi-reader multi-case (MRMC) comparative effectiveness study, nor the effect size of AI assistance.
- Results from a standalone algorithm-only performance study.
- The type of ground truth used (e.g., pathology, outcomes data).
- The sample size for the training set or how its ground truth was established.
The document states the intended use of the devices, which is for the quantitative in-vitro diagnostic determination of transferrin in serum or plasma using T60 Clinical Chemistry Analyzers, aiding in the diagnosis of malnutrition, acute inflammation, acute infection, and iron deficiency anemia. It also specifies the use of SpeciCal as a stock calibrator and SpeciTrol/SpeciTrol High as assayed control serums to monitor precision.
Therefore, I cannot fulfill the request for information on acceptance criteria, study details, or AI-related metrics based on the provided text.
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(124 days)
TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C
Good Biotech Corp. Transferrin test system is intended to be used for the quantitative determination of transferrin in human serum by turbidimetric immunoassay (TIA). Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.
Good Biotech Corp. Transferrin Calibrator Set is intended to be used with Transferrin TIA for the quantitative determination of transferrin in serum samples.
Good Biotech Corp. Transferrin Controls are intended to be used as the assayed quality control material for transferrin analysis.
For In Vitro Diagnostic Use.
Good Biotech Corp. Transferrin TIA is a ready to use reagent for the quantitative determination of transferrin in human serum by turbidimetric immunoassay (TIA). When transferrin of the serum sample encounters with duck anti-transferrin antibody, the aqqlutination based on the antigen-antibody reaction increases the turbidity of the sample. The value of the absorbance change at 505 nm is proportional to the transferrin concentration of the sample and is recorded by a general chemistry autoanalyzer. Then, the actual transferrin concentration of the serum sample is determined by interpolation of the calibration curve obtained by standard samples with known transferrin concentrations.
Here's an analysis of the acceptance criteria and study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state pre-defined acceptance criteria in terms of specific numeric thresholds for slope, intercept, and correlation coefficient. Instead, it relies on a "high correlation coefficient" as an indicator of substantial equivalence. The predicate device's performance characteristics (slope, intercept, correlation coefficient) likely serve as an implicit benchmark for "high correlation."
| Metric | Acceptance Criteria (Implicit from Predicate/General Expectation for Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Slope | Close to 1.0 (indicating similar proportionality) | 0.927 |
| Intercept (mg/dL) | Close to 0.0 (indicating similar baseline/bias) | 19.784 |
| Correlation Coefficient | High (e.g., >0.95 or >0.90, indicating strong linear relationship) | 0.992 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 82 serum samples
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "serum samples."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to this kind of diagnostic device (immunoassay). The "truth" for the test set is established by the measurements obtained from the predicate device, which is an already legally marketed and validated assay. No human experts are used to interpret the results or establish "ground truth" in the way they would for imaging or clinical diagnosis.
4. Adjudication Method for the Test Set
Not applicable. The comparison is between two quantitative assays, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices that involve human interpretation, such as imaging AI, where the impact of AI assistance on human reader performance is evaluated. This submission is for a quantitative immunoassay.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Yes, a standalone study was performed. The device's performance was compared directly against the predicate device without human intervention or interpretation as part of the primary measurement. The "algorithm" here refers to the immunoassay's ability to quantitatively determine transferrin levels.
7. Type of Ground Truth Used
The "ground truth" in this context is the quantitative determination of transferrin levels by the predicate device (Roche Tina-quant Transferrin ver.2). This is a common approach for establishing substantial equivalence for new diagnostic assays, where a well-established and legally marketed device serves as the reference standard.
8. Sample Size for the Training Set
The document does not specify a training set. This is a pre-market submission for an immunoassay, not a machine learning algorithm that typically requires a distinct training and test set in the same way. The development and optimization of the immunoassay reagents and methodology would have been an iterative process by the manufacturer, but the term "training set" as commonly applied to AI/ML is not relevant here. The studies described are for validation/testing.
9. How the Ground Truth for the Training Set Was Established
As no training set (in the AI/ML sense) is explicitly mentioned, this question is not directly applicable. The "ground truth" for the comparative performance study was established by the predicate device's measurements.
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(135 days)
N ANTISERA TO HUMAN TRANSFERRIN
In vitro diagnostic reagents for the quantitative determination of transferrin in human serum, heparinized and EDTA plasma, as well as transferrin in human urine by means of immunonephelometery on the BN™ Systems. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.
Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Study Type) | Reported Device Performance |
|---|---|
| Equivalence in measurement between serum and heparinized or EDTA plasma | Correlation coefficients between 0.96 and 0.98 |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for the test set or the data provenance. It only mentions that "method comparisons were performed."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is an in vitro diagnostic reagent, and the assessment of its performance focuses on analytical equivalence rather than diagnostic interpretation requiring expert review of images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The study involved method comparisons for analytical performance, not clinical 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 in vitro diagnostic reagent, not an AI-powered diagnostic system requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance characteristics described are for the standalone analytical performance of the N Antisera to Human Transferrin assay on the BN™ Systems.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this device's performance demonstration relies on established laboratory measurement methods for transferrin in different sample types (serum, heparinized plasma, EDTA plasma). The "ground truth" implicitly refers to the measurements obtained by these established methods, and the study aims to show equivalence between the modified assay and a legally marketed predicate device (K972840) using these established measurement principles.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device that typically employs training sets. The device is a diagnostic reagent.
9. How the ground truth for the training set was established
Not applicable. As noted above, there is no training set mentioned or implied for this type of device.
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(57 days)
FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002
The "Wiener lab. Fer-Color Transferrina" iron-binding capacity test system is a quantitative in vitro diagnostics device intended to measure iron-binding capacity in serum or plasma. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.
End point method.
Transferrin or specific iron carrier protein is assayed through its physiologic activity of binding Fe (III) (TIBC) at a pH higher than 7.2 in which transferrin is saturated in the presence of excess Fe (III). The remaining unbound Fe (III) is totally removed by coprecipitation with magnesium carbonate. After centrifugation, iron in the supernatant is determined as follows: iron bound to transferrin is released and colorimetrically measured according to Fer-Color procedure.
Such measurement proceeds as follows: iron is released from its specific carrier protein (transferrin) in a pH 4.5 acetate buffer, and in presence of a reducing agent (ascorbic acid). Then it reacts with color reagent, pyridyl bis-phenyl triazine sulfonate (ferrozine) producing a colored complex measured at 570 nm.
The provided document is a 510(k) premarket notification for a medical device called "WIENER LAB FER-COLOR TRANSFERRINA", which is a photometric method for Total-Iron Binding Capacity determination. The document indicates that this device is substantially equivalent to a predicate device, the RANDOX TOTAL-IRON BINDING CAPACITY / IRON test system. However, the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation reports or performance studies.
Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway, rather than detailing a study against predefined acceptance criteria for novel claims.
Here's a breakdown of why the information isn't available in the provided text:
- Acceptance Criteria and Reported Device Performance: This information is not present. A 510(k) summary primarily focuses on comparing the new device to a predicate device to demonstrate substantial equivalence, not on establishing performance against specific acceptance criteria through a dedicated study with quantified results.
- Sample Size and Data Provenance: Not mentioned for any test set. The document does not describe a performance study with a distinct test set.
- Number of Experts and Qualifications: Not applicable as no expert-based ground truth establishment is described.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not mentioned. This type of study is more common for imaging or diagnostic devices where human interpretation plays a significant role. The device is a laboratory assay.
- Standalone Performance Study: A standalone performance study against explicit acceptance criteria with quantitative results is not detailed in this 510(k) summary. The comparison is between the new device and a predicate device.
- Type of Ground Truth Used: Not described. For laboratory assays, ground truth often involves reference methods or established clinical diagnoses, which are not outlined here as part of a formal study.
- Sample Size for Training Set: Not mentioned. The device appears to be a reagent-based assay, not a machine learning algorithm that would typically require a training set.
- How Ground Truth for Training Set was Established: Not applicable.
The document primarily states:
- Device Name: WIENER LAB FER-COLOR TRANSFERRINA
- Intended Use: Quantitative determination of Total Iron binding capacity in human serum and plasma. Used in the diagnosis and treatment of anemia.
- Predicate Device: RANDOX TOTAL-IRON BINDING CAPACITY / IRON test system.
- Equivalencies and Differences: A table comparing the intended use, test principle, reagents, and expected values between the new device and the predicate. The expected values for the Wiener Lab device are stated as 250 - 400 µg/dl. The RANDOX device states 46.0 - 69.5 µmol/l (259 - 388 µg/dl). This comparison serves as the basis for claiming substantial equivalence, implying that similar performance is expected.
To answer your request, a detailed performance study report with specific acceptance criteria and detailed statistical analysis would be required, which is beyond the scope of this 510(k) summary.
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(54 days)
TINA-QUANT TRANSFERRIN VER.2
The cassette COBAS Integra Tina-quant Transferrin ver.2 contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative immunological determination of human transferrin in serum and plasma. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum and plasma. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.
The Tina-quant Transferrin ver.2 Assay is based on the principle of immunological agglutination. Human transferrin forms a precipitate with a specific antiserum which is determined turbidimetrically at 340 nm.
Here's an analysis of the provided information regarding the Tina-quant Transferrin ver.2 device, structured to address your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary for Tina-quant Transferrin ver.2 establishes substantial equivalence to a predicate device (COBAS Integra Tina-quant Transferrin). The "acceptance criteria" can be inferred from the performance characteristics of the predicate device, against which the new device is compared. The reported performance of the new device demonstrates it meets or surpasses the predicate's performance.
| Feature | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Tina-quant Transferrin ver.2) |
|---|---|---|
| Intended Use | Quantitative immunological determination of human transferrin in serum (and other body fluids, for predicate) | Quantitative immunological determination of human transferrin in serum and plasma |
| Indication for Use | Aids in diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders (e.g., iron deficiency anemia) | Aids in diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders (e.g., iron deficiency anemia) |
| Assay Protocol | Immunoturbidimetric assay | Immunoturbidimetric assay |
| Instrument | COBAS Integra Clinical Chemistry Analyzers | COBAS Integra Clinical Chemistry Analyzers |
| Traceability/Standardization | Standardized against CRM 470 (RPPHS) | Standardized against CRM 470 (RPPHS) |
| Sample Type | Human serum (and plasma, other body fluids for predicate) | Human serum and plasma |
| Measuring Range | 80 – 1280 mg/dL (or 0.8 - 12.8 g/L) | 1.3 - 520 mg/dL (or 0.013 - 5.2 g/L) |
| Intra-assay Precision (% CV) | 1.5% at 1.10 g/L, 0.83% at 3.32 g/L | 0.86% at 1.35 g/L, 0.77% at 3.36 g/L |
| Between Day Precision (% CV) | 1.6% at 1.10 g/L, 0.97% at 3.32 g/L | 1.8% at 1.32 g/L, 1.9% at 3.70 g/L |
| Analytical Sensitivity (LDL) | 0.58 g/L | 0.013 g/L |
| Method Comparison (Correlation) | y = 1.06x + 0.01 g/L, r = 0.958 (vs. nephelometric determination) | y = 1.06x + 0.03, r = 0.996 (vs. predicate device) |
| Limitations (Interference) | Icterus: No significant interference; Hemolysis: No significant interference; Lipemia: No significant interference; Rheumatoid factors: No significant interference | Icterus: No significant interference; Hemolysis: No significant interference; Lipemia: No significant interference up to 500 mg/dL; Rheumatoid factors: No significant interference; Gammopathy (IgM): Flagged "High Act", correctable by post-dilution. |
| Calibration Frequency | After reagent lot change | After reagent lot change |
| Expected Values | 2.0 – 3.6 g/L (200 – 360 mg/dL) | 2.0 – 3.6 g/L (200 – 360 mg/dL) |
Summary of how the device meets acceptance criteria:
The Tina-quant Transferrin ver.2 demonstrates substantial equivalence to the predicate device. It maintains the same intended use, indications for use, assay protocol, and instrument compatibility. Its precision (intra-assay and between-day) is comparable to, and in some cases better than, the predicate. A notable improvement is the significantly lower analytical sensitivity (LDL), indicating better detection of low transferrin levels. The method comparison shows a strong correlation with the predicate device, further supporting its equivalence. The limitations regarding common interferences are similar or explicitly managed (e.g., Gammopathy for the new device).
2. Sample Size Used for the Test Set and Data Provenance
The provided document refers to the data as "performance characteristics" and "method comparison."
- Method Comparison: The equation
y = 1.06x + 0.03withr = 0.996implies a regression analysis was performed, comparing the new device (Y) to the predicate device (X). However, the specific sample size (number of patient samples) used for this comparison is not explicitly stated. - Precision (Intra-assay and Between-day): These studies typically involve multiple replicates of control or patient samples. The exact number of samples or replicates is not specified.
- Limitations (Interference): These studies typically involve spiking known interferents into samples. The number of samples used for these interference studies is not specified.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It is generally assumed that studies for FDA submissions are conducted under controlled conditions, often in a prospective manner, but details are absent here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (number and qualifications of experts for ground truth) is typically relevant for diagnostic imaging or subjective biomarker interpretation. For an immunological quantitative assay like transferrin, the "ground truth" is established by a reference method or a validated predicate device.
- For Method Comparison: The predicate device itself (COBAS Integra Transferrin) serves as the reference for comparison. The predicate device's performance was, in turn, previously established against a "nephelometric determination" (another analytical method) for its own method comparison, with an
r = 0.958. - For Standardization: Both devices are standardized against the CRM 470 reference preparation, which corresponds to RPPHS (Reference Preparation Protein in Human Serum). This is a primary standard, not derived from expert consensus.
Therefore, the concept of "experts establishing ground truth" as you might see in imaging (e.g., radiologists) is not applicable in the same way for this type of quantitative biochemical assay. The ground truth is the analytically measured concentration against recognized standards.
4. Adjudication Method for the Test Set
Again, for a quantitative biochemical assay, an "adjudication method" (like 2+1 or 3+1 for clinical diagnoses) is not typically employed. The results are numerical values output by the instrument. Any discrepancies between the new device and the predicate are analyzed statistically (e.g., correlation, bias), not through clinical adjudication in the human sense.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done for this device. This type of study investigates how human readers (e.g., clinicians, radiologists) perform with and without AI assistance on various cases. The Tina-quant Transferrin ver.2 is a fully automated in-vitro diagnostic reagent system that provides a quantitative measurement; it does not involve human interpretation in a diagnostic workflow that could be "assisted" by AI in the MRMC sense.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is essentially a standalone system in that it provides a direct quantitative measurement. The "performance characteristics" (precision, analytical sensitivity, measuring range, interference) represent the performance of the algorithm/reagent system without human intervention influencing the measurement itself. The results are then read and interpreted by a human user, but the measurement is algorithmic. So, in essence, its core performance evaluation is "standalone."
7. The Type of Ground Truth Used
The ground truth for evaluating the Tina-quant Transferrin ver.2 is primarily established through:
- Reference Standards: Standardization against the CRM 470 (RPPHS) reference preparation.
- Comparison to a Validated Predicate Device: The performance of the new device is directly compared to an already legally marketed and accepted device (COBAS Integra Tina-quant Transferrin). This predicate device itself had its performance validated against other established analytical methods (e.g., nephelometric determination).
- Analytical Measurement: The inherent analytical capabilities of the immunoturbidimetric assay technology to accurately quantify transferrin concentration.
8. The Sample Size for the Training Set
This document describes a premarket submission for a medical device that is a reagent system for a laboratory assay. It is not an AI/ML-based device in the common sense that would involve a "training set" for model development. The parameters and performance of such a device are determined through chemical and mechanical engineering, and extensive analytical validation. Therefore, the concept of a "training set sample size" as used for AI/ML algorithms does not apply to this specific device.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, the concept of a "training set" and associated "ground truth" (in the context of AI/ML) is not applicable to this device. For traditional in-vitro diagnostic assays, the "ground truth" for calibrating the system and establishing its performance involves using precisely characterized reference materials (like CRM 470) and known concentrations of analytes, which are then used to set the instrument's calibration curve and validate its analytical accuracy across its measuring range.
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(55 days)
TINA-QUANT TRANSFERRIN VER.2
Immunoturbidometric assay for the in vitro quantitative determination of transferrin in human serum and plasma on automated clinical chemistry analyzers. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum and plasma. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.
The Tina-quant Transferrin ver.2 Assay is based on the principle of immunological agglutination. Anti-transferrin antibodies react with the antigen in the sample to form an antigen/antibody complex. Following agglutination, this is measured turbidimetrically. Addition of PEG allows the reaction to progress rapidly to the end point and increases sensitivity.
This is a submission for a medical device (specifically, an in-vitro diagnostic assay) rather than a software-as-a-medical-device (SaMD) or AI/ML device. Therefore, many of the requested elements (like "experts used to establish ground truth," "adjudication method," "MRMC study," and "training set") are not applicable in the context of this traditional assay. The performance is evaluated through analytical studies, not clinical studies involving human interpretation of AI outputs.
Here's the information that can be extracted from the provided text, adapted for an in-vitro diagnostic assay:
Acceptance Criteria and Device Performance
The acceptance criteria are implicitly defined by demonstrating equivalent or improved performance characteristics compared to the predicate device.
| Feature | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Tina-quant Transferrin ver.2) |
|---|---|---|
| Intended Use | Immunoturbidometric assay for the in vitro quantitative determination of transferrin in human serum and plasma on automated clinical chemistry analyzers. | Equivalent: Immunoturbidometric assay for the in vitro quantitative determination of transferrin in human serum and plasma on automated clinical chemistry analyzers. |
| Indication for Use | Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia. | Equivalent: Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia. |
| Measuring Range (Roche/Hitachi 704/902) | 80 - 500 mg/dl | Improved: 0.02 - 5.00 g/l (1 - 500 mg/dl) |
| Measuring Range (Roche/Hitachi 717/747) | 80 - 500 mg/dl (Extended with rerun: 80 - 1000 mg/dl) | Improved: 0.02 - 5.00 g/l (1 - 500 mg/dl) (Extended with rerun: 0.02 - 7.50 g/l (1-750 mg/dl)). Note: The ver.2 device states "Maximum reportable range is dependent on the highest standard concentration" for the extended range, which is similar wording to the predicate, but the values are lower and potentially offer wider usability. |
| Measuring Range (Roche/Hitachi 904/911/912/917/Modular P) | 15 - 500 mg/dl | Improved: 0.007 - 5.20 g/l (0.7 - 520 mg/dl) (Extended with rerun: 0.007 - 7.80 g/l (0.7 - 780 mg/dl)). Note: The ver.2 device states "Maximum reportable range is dependent on the highest standard concentration" for the extended range, which is similar wording to the predicate, but the values are lower and potentially offer wider usability. |
| Intra-assay precision (% CV) - Human Sera | 0.8% at 169 mg/dl | Comparable/Improved: 1.0% at 1.36 g/l (136 mg/dl), 2.7% at 3.59 g/l (359 mg/dl). Precision is concentration-dependent; the values are generally comparable across similar concentrations but the ver.2 provides more data points. |
| Intra-assay precision (% CV) - Controls | 0.8% at 217 mg/dl, 0.8% at 403 mg/dl | Comparable/Improved: 2.1% at 2.90 g/l (290 mg/dl), 1.0% at 4.31 g/l (431 mg/dl). Similar for controls, concentration-dependent, providing comparable performance across ranges. |
| Between Day Precision (% CV) - Human Sera | 3.0% at 169 mg/dl | Improved: 0.0% at 1.60 g/l (160 mg/dl), 1.4% at 3.38 g/l (338 mg/dl). Shows better or comparable between-day precision at different concentrations to the predicate. |
| Between Day Precision (% CV) - Controls | 1.4% at 217 mg/dl, 1.5% at 403 mg/dl | Comparable/Improved: 1.7% at 2.88 g/l (288 mg/dl), 1.4% at 4.35 g/l (435 mg/dl). Similar between-day precision for controls. |
| Icterus Interference | No significant interference from bilirubin up to an I index of 60 | Equivalent: No significant interference with up to an I index of 60 |
| Hemolysis Interference | No significant interference from hemoglobin up to an H index of 1000 | Equivalent: No significant interference up to an H index of 1000 |
| Lipemia Interference | No significant interference from lipemia up to an L index of 600 | Comparable: No significant interference up to an L index of 500 (slight reduction compared to predicate's L index of 600) |
| Rheumatoid Factors Interference |
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