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510(k) Data Aggregation
(84 days)
Drive Chaska, Minnesota 55318
Re: K240987
Trade/Device Name: Access sTfR Regulation Number: 21 CFR 866.5880
Analyzer Classification Name: Transferrin immunological test system Classification Requlation: [21 CFR 866.5880
The Access sTfR assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of soluble transferrin receptor (sTR) levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of Iron Deficiency Anemia (IDA), and for the differential diagnosis of IDA and Anemia of Chronic Disease (ACD).
This assay may also be used in conunction with an Access Ferritin measurement to provide a calculated sTR log ferritin index. This index is intended as an aid in the diagnosis of IDA, and for the differential diagnosis of IDA and ACD.
Access sTfR: The sTfR assay reagent pack consists of two specific reagents: (R1a) paramagnetic particles coated with streptavidin:biotinylated soluble transferrin receptor monoclonal antibody, proteins (mouse, goat, bovine), bovine serum albumin (BSA), 0.1% sodium azide, and 0.17% ProClin 300; and (R1b) Monoclonal mouse anti-human soluble transferrin receptor alkaline phosphatase (bovine) conjugate, BSA, 0.1% sodium azide and 0.17% ProClin 300. Two assay packs containing 50 tests per pack are provided for a total of 100 assay determinations.
The Access sTfR assay is a sequential two-step immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel along with paramagnetic particles coated with anti-sTfR antibody. During incubation, the sTfR antigen in the sample binds to the immobilized anti-sTfR antibody on the solid phase. Alkaline phosphatase conjugated anti-sTfR antibody is then added and reacts with a different antigenic site on the sTfR molecule.
After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.
Here's a breakdown of the acceptance criteria and study information for the Access sTfR device, based on the provided FDA 510(k) summary:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| Method Comparison | Slope: 0.99 – 1.01 (95% CI) | Slope: 1.00 (95% CI: 0.99 – 1.01) | Yes |
| Intercept: -0.14 - 0.15 (95% CI) | Intercept: -0.016 (95% CI: -0.14 - 0.15) | Yes | |
| Correlation Coefficient (R): Not explicitly stated as acceptance, but comparison shows R = 1.00 | Correlation Coefficient (R): 1.00 | Yes (Excellent) | |
| Imprecision | ≤ 0.72 nmol/L SD at concentrations ≤ 9 nmol/L | Sample 1 (9.1 nmol/L): 0.24 nmol/L SD | Yes |
| ≤ 8.0% CV at concentrations > 9 nmol/L | Sample 2 (17 nmol/L): 2.6% CV |
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(382 days)
Not Found
Not Found
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)
: | Class II / 510(k) required |
| Classification Name: | §866.5880
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)
Trade/Device Name: Tina-quant Transferrin ver.2 (urine application) Regulation Number: 21 CFR 866.5880
| |
| Product Codes,
Regulation Numbers | DDG, 21 CFR § 866.5880
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)
Trade/Device Name: Human Transferrin kit for use on the SPAPlus™ Regulation Number: 21 CFR §866.5880
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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(158 days)
Trade/Device Name: Access® sTfR, Access® sTfR Calibrators and Access® sTfR OC Regulation Number: 21 CFR 866.5880
The Access sTfR assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of soluble transferrin receptor (sTfR) levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of Iron Deficiency Anemia (IDA), and for the differential diagnosis of IDA and Anemia of Chronic Disease (ACD).
This assay may also be used in conjunction with a ferritin measurement to provide a calculated sTfR/log ferritin index. This index is intended as an aid in the diagnosis of IDA, and for the differential diagnosis of IDA and ACD.
The Access sTfR Calibrators are intended to calibrate the Access sTfR assay for the quantitative determination of soluble transferrin receptor levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
The Access sTfR QC is intended for monitoring system performance of the Access sTfR assay.
The Access sTfR reagent, calibrators, controls, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, UniCel DxC 600i, UniCel Dxl 600, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the quantitative determination of soluble transferrin receptor in human serum and plasma.
Automated; Paramagnetic particles coated with mouse monoclonal antibody against sTfR. Uses the same mouse monoclonal antibodies against sTfR in the capture phase and signal phase as the predicate device.
Utilizes dioxetane-based chemiluminescent substrate; measures light production from a chemiluminescent reaction.
Calibrators are comprised of natural sTfR at 6 levels (0, 3, 10, 30, 80, and 150 nmol/L) in a buffered matrix.
QCs are human sTfR provided as a liquid at 3 levels (~10, ~25, ~90 nmol/L) in a buffered matrix.
Here's an analysis of the provided text to fulfill your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Access sTfR) |
|---|---|---|
| Imprecision (Total precision) | ≤ 8% CV for concentrations > 9 nmol/L | 2.6 to 5.4% CV for samples > 9 nmol/L |
| Imprecision (Total precision) | 9 nmol/L | |
| Imprecision (Within run precision) | Not explicitly stated, but generally lower than total precision | 0.04-0.22 nmol/L SD for samples ≤ 9 nmol/L |
| Analytical Sensitivity (Lowest detectable level) | Not explicitly stated, but should be distinguishably non-zero | 0.95 or similar) |
| Analytical Specificity (Interference avoidance) | No significant interference from therapeutic drugs, similar compounds, or common contaminants | No significant interference from therapeutic drugs, similar compounds, bilirubin, total protein, hemoglobin, triglycerides, or rheumatoid factor (up to 850 IU/mL) |
| Reagent Stability (Opened) | Not explicitly stated, but ensures practical shelf-life | 28 days |
| Calibrator Stability (Opened) | Not explicitly stated, but ensures practical shelf-life | 90 days |
| Control Stability (Opened) | Not explicitly stated, but ensures practical shelf-life | 90 days |
| Calibration Curve Stability | Not explicitly stated, but ensures practical shelf-life | 28 days |
| Clinical Sensitivity (sTfR for IDA/ACD+IDA) | Optimized sensitivity with reasonable specificity | 86% sensitivity at 21 nmol/L cutoff |
| Clinical Specificity (sTfR for IDA/ACD+IDA) | Optimized specificity with reasonable sensitivity | 49.1% specificity at 21 nmol/L cutoff |
| Clinical Sensitivity (sTfR/log ferritin index for IDA/ACD+IDA) | Optimal sensitivity | 80.7% sensitivity at 14 cutoff |
| Clinical Specificity (sTfR/log ferritin index for IDA/ACD+IDA) | Optimal specificity | 82.5% specificity at 14 cutoff |
2. Sample Size Used for the Test Set and Data Provenance
-
Methods Comparison (Analytical Study):
- Sample Size: 271 samples
- Data Provenance: Not explicitly stated, but implies clinical samples used for comparing the new assay to the predicate. The "External Site" suggests multiple locations.
- Retrospective/Prospective: Not specified.
-
Clinical Studies (Clinical Trial):
- Sample Size: Not explicitly stated for the clinical trial itself, but implied to be sufficient to derive sensitivity and specificity values.
- Data Provenance: "Prospective multicenter clinical trial." This indicates data was collected forward-in-time from multiple clinical sites. The country of origin is not specified.
- Retrospective/Prospective: Prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. For the clinical studies, "diagnosis of Iron Deficiency Anemia (IDA), and for the differential diagnosis of IDA and Anemia of Chronic Disease (ACD)" would typically involve clinical experts (e.g., hematologists, clinical pathologists), but the number and qualifications are not mentioned.
4. Adjudication Method for the Test Set
This information is not provided in the document. For clinical diagnoses used as ground truth, an adjudication process (e.g., consensus by multiple experts) is often used, but it's not detailed here.
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
There was no MRMC comparative effectiveness study described. This device is an in vitro diagnostic (IVD) assay for measuring a biomarker (sTfR), not an AI-powered image analysis or diagnostic aid that would assist human readers in interpreting images or other complex data. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this specific device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies described are for the device's standalone performance as an in vitro diagnostic assay. The "Access sTfR reagents, calibrators, controls, and the Access Immunoassay Analyzers" perform the quantitative determination of sTfR levels. There isn't a human-in-the-loop component in the actual measurement and result generation of the sTfR value itself. The clinical interpretation of that sTfR result (and sTfR/log ferritin index) is then performed by a clinician.
7. The Type of Ground Truth Used
- Analytical Studies (Methods Comparison): The ground truth for method comparison was values obtained from the predicate device (Quantikine® IVD® sTfR ELISA). This is a common approach for demonstrating substantial equivalence for quantitative assays.
- Clinical Studies: The ground truth for the clinical study was the diagnosis of Iron Deficiency Anemia (IDA) and Anemia of Chronic Disease (ACD). This would typically be established through a combination of clinical assessment, laboratory tests (beyond just sTfR), and potentially bone marrow biopsy or response to iron therapy, which constitutes outcomes data or expert consensus-based clinical diagnosis. The document does not specify the exact methods for defining IDA and ACD beyond the general diagnoses.
8. The Sample Size for the Training Set
The document does not explicitly describe a "training set" in the context of an algorithm or machine learning model. This is an immunoassay (laboratory test), not a software/AI device that typically undergoes separate training and test phases.
- The "analytical studies" and "clinical studies" described serve as validation studies for the device's performance, much like a traditional device's verification and validation.
- There's no mention of a development phase where a model would be "trained" on a specific dataset.
9. How the Ground Truth for the Training Set Was Established
As there is no explicit "training set" mentioned in the context of typical machine learning, this question is not applicable. The development and optimization of the immunoassay reagents and protocols are based on scientific principles of immunology and chemistry, rather than an algorithmic training process on ground truth data.
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(92 days)
Dimension Vista® System Protein 3 Control with models K7072, KC710 and KC775 Regulation Number: 21 CFR 866.5880
The TRF method is an in vitro diagnostic test for the quantitative measurement of transferrin in human serum, heparinized plasma, EDTA plasma or urine on the Dimension Vista® System. Measurements of transferrin aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia.
Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the Dimension Vista® System for: α₁-Acid Glycoprotein (A1AG), α₁-Antitrypsin (A1AT), β₂-Microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Hemopexin (HPX), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG) [serum/plasma] and (IGG-C) [cerebrospinal fluid], Immunoglobulin G Subclass 1 (IGG1), Immunoglobulin G Subclass 2 (IGG2), Immunoglobulin G Subclass 3 (IGG3), Immunoglobulin G Subclass 4 (IGG4), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), soluble Transferrin Receptor (STFR), Transferrin (TRF) [serum/plasma] and (TRF-U) [urine].
PROT3 CON is an assayed, low level intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the determination of α -Microglobulin (A1MIC), specialty Albumin (sALB*), Immunoglobulin G (IGG -C*), Microalbumin (MALB) and Transferrin (TRF-U**). * For Cerebrospinal fluid (CSF) ** For urine
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 respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing q acid glycoprotein, a-antitrypsin, ß2-microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocystine, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G subclass 1, immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M, prealbumin, retinol binding protein, soluble transferrin receptor and transferrin.
Protrein 3 Control is a multi-analyte, lyophilized, polygeline and rabbit plasma albumin based product containing a - Microglobulin, albumin, immunoglobulin G and transferrin.
Here's a breakdown of the acceptance criteria and study information for the Siemens Healthcare Diagnostics Inc. 510(k) Notification for the Dimension Vista® System TRF Flex® reagent cartridge, Protein 1 Calibrator, and Protein 3 Control, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary primarily focuses on establishing substantial equivalence through a method comparison study. It does not explicitly state pre-defined acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy against a gold standard, or specific numerical targets for regression analysis. Instead, the "acceptance criteria" can be inferred as achieving a strong correlation and suitable regression statistics (slope, intercept, correlation coefficient) when compared to the legally marketed predicate device.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Strong correlation with predicate device (Dade Behring N Antisera to Human Transferrin on BN ProSpec® System) for Transferrin (TRF) measurements in urine. | Regression Analysis: Equation provided: (Specific regression equation not fully legible in the provided text, but mentioned as having been performed). |
| Suitable regression statistics (slope, intercept, correlation coefficient) demonstrating substantial equivalence. | Demonstrated substantial equivalence based on correlation studies and provided information. |
| The modified Dimension Vista® System TRF assay, Protein 1 Calibrator, and Protein 3 Control are substantially equivalent to the legally marketed devices. | Conclusion states that the devices are substantially equivalent based on the correlation studies. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The study evaluated urine samples with concentrations ranging from 2.0 to 24.4 mg/L. The exact number of samples is not explicitly stated in the provided text.
- Data Provenance: The text does not specify the country of origin of the data. The study appears to be prospective in nature, comparing the new device against an existing one in a method comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" here is not established by expert consensus on clinical interpretation, but rather by the measurements obtained from the legally marketed predicate device. This is a measurement device comparison, not a diagnostic interpretation device.
4. Adjudication Method for the Test Set
This is not applicable as the study is a method comparison of quantitative measurements, not a diagnostic interpretation that typically involves adjudication of reader disagreements.
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
This is not applicable. The device is an in vitro diagnostic (IVD) reagent and calibrator/control system for quantitative measurement, not an AI-assisted diagnostic imaging or interpretation tool that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The device itself is a standalone measurement system (reagent, calibrator, control used on an automated analyzer). The comparison study implicitly tests the standalone performance of the Dimension Vista® System TRF assay against the predicate device. The performance data presented directly reflects the algorithmic (or analytical) output of the device.
7. The Type of Ground Truth Used
The "ground truth" in this context is the measurements obtained from the legally marketed predicate device: the Dade Behring N Antisera to Human Transferrin assay on the BN ProSpec® System. This is a form of comparative analytical performance against an established method.
8. The Sample Size for the Training Set
This is not applicable. This submission describes an in vitro diagnostic test system (reagent, calibrator, control). These types of devices do not typically involve "training sets" in the same way machine learning algorithms do. The development of the assay would involve internal optimization and validation, but not a distinct "training set" for an algorithm in the sense of AI.
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 is not applicable to this type of IVD device submission.
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(302 days)
Transferrin, Specical Calibrator, Specitrol Control and Specitrol High Control Regulation Number: 21 CFR 866.5880
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)
|
| Classification name | Transferrin immunological test system (21 CFR § 866.5880
Control-M, Control-H Regulation Number: 21 CFR 866.5880 Regulation Name: Transferrin Immunological Test
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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(103 days)
Dimension Vista™ Protein 1 Control M Dimension VistaTM Protein 1 Control H Regulation Number: 21 CFR§866.5880
Dimension Vista™ STFR Flex® reagent cartridge: The STFR method is an in vitro diagnostic test for the quantitative determination of soluble transferrin receptor in human serum and heparinized plasma on the Dimension Vista System. Measurements of soluble transferrin receptor aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia.
Dimension Vista™ Protein 1 Calibrator: PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), Prealbumin (PREALB) and Soluble Transferrin Receptor (STFR), methods on the Dimension Vista System.
Dimension Vista™ Protein 1 Control L, M and H: PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 complement (C3), C4 complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), prealbumin (PREALB) and soluble transferrin receptor (STFR) on the Dimension Vista System.
Dimension Vista™ STFR Flex reagent cartridge: Polystyrene particles coated with monoclonal antibodies specific to human soluble transferrin receptor are aggregated when mixed with samples containing soluble transferrin receptor. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liguid, human serum based product containing C3 Complement, C4 Complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) and Soluble Transferrin Receptor (STFR).
Dimension Vista™ Protein 1 Control L. M and H: Protein 1 Control L, M and H are multi-analyte, liquid, human serum based products containing C3 complement, C4 complement, immunoqlobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) and soluble transferrin receptor (STFR).
Here's a breakdown of the acceptance criteria and study information for the Dimension Vista™ STFR Flex® reagent cartridge, Dimension Vista™ Protein 1 Calibrator, and Dimension Vista™ Protein 1 Control L, M, and H:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a method comparison study between the new device and a legally marketed predicate device. The acceptance criteria are implicitly defined by the reported regression analysis results, which demonstrate a strong correlation and "equivalent performance" to the predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance (Dimension Vista™ STFR Flex® compared to N Latex sTFR on BN ProSpec® System) |
|---|---|
| Strong correlation | Correlation Coefficient: 0.997 |
| Slope close to 1 | Slope: 1.053 |
| Intercept close to 0 | Intercept: -0.078 mg/L |
| Equivalent performance | "These studies demonstrate correlation and equivalent performance" |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 153 serum and plasma samples.
- Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. It only mentions that "serum and plasma samples with concentrations ranging from 0.21 mg/L to 4.13 mg/L" were evaluated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given summary. The ground truth in this context is implicitly established by the measurements obtained from the predicate device (Dade Behring N Latex sTFR assay on the BN ProSpec® System).
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided in the given summary. The study is a quantitative method comparison between two automated diagnostic devices, not a study requiring expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a method comparison between two in vitro diagnostic (IVD) devices for quantitative measurement of an analyte, not a study involving human readers or interpretation of medical images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The study directly assesses the performance of the Dimension Vista™ STFR assay on the Dimension Vista System against a predicate device, without involving human interpretation or modifications to the results.
7. The Type of Ground Truth Used
The "ground truth" for this study was established through the measurements obtained from the legally marketed predicate device, the Dade Behring N Latex sTFR assay on the BN ProSpec® System. This is a common practice in IVD device submissions to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
This information is not provided in the given summary. The document describes a comparison study for the finalized device, not the development or training of an algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the given summary, as the submission focuses on the performance of the final device rather than its developmental stages or training data.
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