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510(k) Data Aggregation
(624 days)
DBF
The DiaSorin LIAISON® Ferritin assay is a quantitative automated chemiluminescent immunoassay (CLIA) for the in vitro detection of ferritin in human serum, serum separator tubes (SST), or lithium (Li) heparin plasma to aid in the diagnosis of iron deficiency anemia and iron overload.
This assay must be performed on the LIAISON® XL Analyzer.
The chemiluminescence immunoassay method for the quantitative determination of ferritin is a sandwich immunoassay.
A specific mouse monoclonal antibody is coated on the magnetic particles (solid phase); another monoclonal antibody (mouse) is linked to an isoluminol derivative (isoluminolantibody conjugate).
During the incubation, ferritin present in calibrators, samples or controls binds to the solid phase monoclonal antibody, and subsequently the antibody conjugate reacts with ferritin already bound to the solid phase.
After incubation, the unbound material is removed with a wash cycle.
Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody coniugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of ferritin concentration present in calibrators, samples or controls.
The provided document is a 510(k) Summary for the DiaSorin LIAISON® Ferritin assay, a chemiluminescent immunoassay for the quantitative determination of ferritin in human serum, serum separator tubes (SST), or lithium (Li) heparin plasma. Its intended use is to aid in the diagnosis of iron deficiency anemia and iron overload.
This document details the performance characteristics required to demonstrate substantial equivalence to a legally marketed predicate device (Roche Elecsys® Ferritin assay), rather than defining and proving against acceptance criteria in the context of an AI/ML device or a complex diagnostic with multiple discrete outcomes. The data presented are for an in vitro diagnostic immunoassay, which relies on analytical performance metrics rather than clinical outcome studies of the type implied by the original request's questions about expert consensus, MRMC studies, human-in-the-loop performance, etc.
Therefore, many of the requested elements are not applicable to the type of device and study described in this document.
Below, I've addressed the applicable points from your request based on the provided text.
Device: DiaSorin LIAISON® Ferritin assay (K193650)
Type of Device: Quantitative automated chemiluminescent immunoassay (CLIA) for the in vitro detection of ferritin.
Purpose of the Study (as presented in the 510(k) Summary): To demonstrate substantial equivalence of the DiaSorin LIAISON® Ferritin assay to the predicate device, Roche Elecsys® Ferritin assay, based on analytical performance characteristics.
Acceptance Criteria and Reported Device Performance
For an in vitro diagnostic assay, acceptance criteria typically relate to analytical performance metrics to ensure accuracy, precision, linearity, and other factors. While the document does not explicitly list "acceptance criteria" against each performance metric in a table format, it reports the results of various studies (e.g., method comparison, precision) which would have been previously agreed upon with the FDA as sufficient to demonstrate substantial equivalence.
Here's a summary of the reported performance. The implied "acceptance criteria" are that these results fall within acceptable ranges for diagnostic assays of this type, often relative to a predicate device or industry standards (e.g., CLSI guidelines).
| Performance Metric | Reported Device Performance (LIAISON® Ferritin) | Implied Acceptance Criteria (based on context of 510(k)) |
|---|---|---|
| Method Comparison (vs. Reference Method) | Regression Analysis (Passing & Bablok): |
- Slope: 0.965 (95% CI: 0.95 - 0.98)
- Intercept: -1.12 (95% CI: -2.13 to -0.32)
- R²: 0.995 | Slope close to 1, Intercept close to 0, and R² close to 1, indicating strong agreement with the reference method (likely the predicate or another validated method), within pre-defined acceptable limits for analytical measurements. |
| Sample Matrix Comparison | Serum vs. SST: - Slope: 1.002 (0.9727 to 1.038)
- Intercept: 0.0179 (-0.7744 to 0.6374)
Serum vs. Li Heparin: - Slope: 0.984 (0.9413 to 0.9905)
- Intercept: -1.732 (-2.137 to -0.5159) | Slopes near 1 and intercepts near 0 for different matrix types compared to serum, demonstrating equivalence across specified sample types. |
| Precision (Total %CV) | Kit Control 1 (32.81 ng/mL): 4.3%
Kit Control 2 (300 ng/mL): 5.4%
Panel 1 (5.84 ng/mL): 5.6%
Panel 2 (18.26 ng/mL): 4.6%
Panel 3 (178 ng/mL): 4.1%
Panel 4 (1093 ng/mL): 5.6%
Panel 5 (404.9 ng/mL): 4.6%
Panel 6 (1883 ng/mL): 6.4% | Total CV (Coefficient of Variation) within acceptable limits for a quantitative immunoassay across its measuring range, demonstrating reproducibility and reliability of results. These limits are typically defined by regulatory bodies or industry standards (e.g., CLSI EP5-A3). |
| Linearity | Equation for 2000 ng/mL sample:
Observed Ferritin = -1.402 + 1.006 * Expected Ferritin
R²=1.000 | R² close to 1, and slope near 1 with intercept near 0, demonstrating accurate measurement across the assay’s claimed analytical measuring range (0.46 – 2,200 ng/mL). |
| Recovery | Average Recovery: 101% (Individual recoveries ranging from 98% to 104% for spiked samples) | Recovery values typically between 90-110% (or tighter, depending on the analyte and assay sensitivity) for spiked samples, indicating the assay accurately measures the target analyte when added to a sample. |
| Limit of Blank (LoB) | 0.004 ng/mL | LoB consistent with the lower end of the claimed analytical measuring range and adequate for the intended clinical application. |
| Limit of Detection (LoD) | 100.0%
Human spleen ferritin: 78.8% | Specificity for the intended analyte (ferritin) without significant cross-reactivity with closely related substances or other components that could lead to false results. |
Applicable Information from the Request (Based on provided document):
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A table of acceptance criteria and the reported device performance: See table above.
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Sample sizes used for the test set and the data provenance:
- Method Comparison: 173 samples. Provenance not specified (e.g., country of origin, retrospective/prospective), but it usually implies clinical samples collected for analytical validation purposes.
- Sample Matrix Comparison: 37 matched patient sets (serum, Li Heparin plasma) and 6 contrived matched patient samples. Provenance not specified.
- Expected Values/Reference Range: 78 human serum samples; 39 healthy female, 39 healthy male subjects (age 18+). Provenance not specified.
- Precision: 2 kit controls and 6 samples assayed 320 times each (twice per day in duplicate, over 20 operating days on two LIAISON® XL Analyzers using two reagent lots). Provenance: DiaSorin GmbH, implying internal lab testing.
- Linearity: Dilution series of 4 samples.
- Recovery: 4 representative human serum samples. Provenance not specified.
- Interference, Cross-Reactivity, LoB/LoD/LoQ studies also involved specific numbers of samples/replicates, but detailed sample sizes for each are not individually listed beyond the overall study design (e.g., "controlled studies... at Ferritin level of approximately 20 ng/mL and 2000 ng/mL").
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document describes an in vitro diagnostic device measuring a quantitative biomarker (Ferritin). Ground truth is established through reference methods, calibration materials traceable to international standards (e.g., NIBSC 94/572 for Ferritin), and gravimetric/dilution/spiking studies, not by expert interpretation of images or clinical outcomes that require human experts for ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for studies involving human interpretation (e.g., radiology reads) where discrepancies need to be resolved. This is an automated analytical test.
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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 assay, not an AI/ML device that assists human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an "algorithm" as typically referred to in AI/ML. The device itself is an automated analyzer that performs the "standalone" measurement of ferritin. No human interpretation is involved in the measurement process after sample loading.
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The type of ground truth used:
- For Method Comparison, the "Reference Method" was used as ground truth. This would typically be a highly accurate and precise method, often the predicate device itself or a laboratory developed test that is well-validated.
- For Linearity and Recovery, ground truth was established by preparing samples with known concentrations through spiking and dilution from a characterized stock solution or pool.
- For Precision, samples with known (or previously characterized) ferritin concentrations were used.
- For Traceability, the calibrators are traceable to an internal reference standard "oriented at the 2nd reference standard NIBSC 94/572." This international standard serves as a form of ground truth for absolute concentration.
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The sample size for the training set: Not applicable. This is a traditional immunoassay, not an AI/ML device that requires a "training set" in the computational sense. The "training" of such a system involves calibrating it with known standards, which were traceable to an international reference standard (NIBSC 94/572).
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How the ground truth for the training set was established: Not applicable, as there is no "training set" in the AI/ML sense. Calibration is performed using materials traceable to an international reference standard.
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(267 days)
DBF
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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(90 days)
DBF
The Atellica™ IM Ferritin (Fer) assay is for in vitro diagnostic use in the quantitative determination of ferritin in human serum and plasma (EDTA and lithium heparin) using the Atellica™ IM Analyzer. This assay can be used as an aid in the diagnosis of iron deficiency anemia and iron overload.
The Atellica Ferritin Assay kit includes the following components: Lite Reagent: 5.0 mL/reagent pack. Contains Goat polyclonal anti-ferritin antibody (~0.64 µg/mL) labeled with acridinium ester in HEPES buffer; protein stabilizers; sodium azide (
Here's a breakdown of the acceptance criteria and study details for the Atellica IM Ferritin Assay, based on the provided document:
Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision | CLSI EP05-A3 guidelines (Evaluation of Precision Performance of Quantitative Measurement Methods) | Repeatability (Within-run): CV ranges from 1.2% to 3.5% for samples (4.2 ng/mL to 1453.6 ng/mL) and 1.2% to 1.6% for controls (51.8 ng/mL to 374.0 ng/mL). |
| Within-Lab (Total Imprecision): CV ranges from 4.0% to 7.2% for samples and 4.5% to 5.5% for controls. | ||
| Linearity/Assay Reportable Range | CLSI EP06-A (linearity of Quantitative Measurement Procedures). Implied: Acceptable percentage difference between observed and predicted values. | The linearity data supports an analytical measuring range of 0.9 - 1650 ng/mL. |
| Predicted % Difference (Y-Ŷ)/Ŷ*100: values ranged from -8.88% to 9.47% (excluding the lowest observed value of 0.20 ng/mL which was |
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(267 days)
DBF
The Diazyme Ferritin Assay is for the quantitative determination of ferritin in human serum. K2EDTA plasma, and lithium heparin plasma on Hitachi 917 analyzer. For in vitro diagnostic use only.
The Diazyme Ferritin Calibrator Set is intended for use in the Diazyme Ferritin Assay. For in vitro diagnostic use only.
The Diazyme Ferritin Control Set is intended for use as quality controls for the Diazyme Ferritin Assay. For in vitro diagnostic use only.
Not Found
The provided text describes a 510(k) premarket notification for a medical device, the Diazyme Ferritin Assay. It primarily focuses on the FDA's determination of substantial equivalence to a predicate device and general regulatory information.
The document does NOT contain information about acceptance criteria, device performance, an actual study proving device performance, sample sizes for test sets or training sets, data provenance, expert qualifications, ground truth establishment, adjudication methods, or MRMC studies.
Therefore, I cannot fulfill your request for that specific information based on the provided text. The document is a regulatory approval letter, not a scientific study report.
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(30 days)
DBF
The K-ASSAY® Ferritin (2nd Gen.) assay is an in vitro diagnostic reagent for the quantitative determination of ferritin (an iron-storing protein) in human serum and plasma by immunoturbidimetric assay on the Beckman AU680 analyzer. Measurements of ferritin aid in the diagnosis of diseases affecting iron overload and iron deficiency anemia. For in vitro diagnostic use.
The K-ASSAY® Ferritin Calibrator (2nd Gen.) is an in vitro diagnostic reagent for calibration of the K-ASSAY® Ferritin (2nd Gen.) assay. For in vitro diagnostic use.
The K-ASSAY® Ferritin (2nd Gen.) assay is a latex enhanced immuno-turbidimetric assay for the quantitative in vitro determination of ferritin levels in serum and plasma (EDTA and heparin) samples.
The K-ASSAY® Ferritin (2nd Gen.) consists of two reagents. Reagent 1 contains HEPES buffer solution (50 mmol/L) and Reagent 2 contains HEPES buffer solution (50 mmol/L) and a solution of latex suspension with mouse monoclonal anti-human ferritin antibodies. Both reagents also contain less than 0:01 w/v% of sodium azide as a preservative.
The K-ASSAY® Ferritin Calibrators (2nd Gen.) are liquid stable products consisting of a human serum matrix and known quantities of human ferritin at 6 levels ranging from 0 -1,000 ng/mL (0, 25, 250, 500, 750, 1,000 ng/mL). The calibrators also contain less than 0.1 w/v% of sodium azide as a preservative.
Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Precision | Between-lot CV% |
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The ADVIA® 1650 Chemistry Ferritin (FRT) Reagent: For in vitro diagnostic use in the quantitative determination of ferritin in human serum and plasma on the ADVIA® 1650 Chemistry system. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
The ADVIA® Chemistry Liquid Specific Protein Calibrators: For in vitro diagnostic use in the calibration of ADVIA® Chemistry systems for the Alpha-Acid-Glycoprotein (AAG), Alpha-1-Antitrypsin (AAT), Anti-streptolysin-O 2 (ASO_2), Complement C3 (C3), Complement C4 (C4), Ferritin (FRT), Haptoglobin (HAPT), Immunoglobulin A_2 (IGA_2), Immunoglobulin G 2 (IGG 2), Immunoglobulin M_2 (IGM_2), Prealbumin (PREALB), Rheumatoid Factor (RF), and Transferrin (TRF) methods.
The Ferritin reagents are ready-to-use liquid reagents. They are supplied in two different package sizes: 200 tests/wedge, 4 wedges/kit and 800 tests/wedge, 4 wedges/kit. In the ADVIA Chemistry Ferritin assay, sample is diluted and reacted with a buffer containing latex particles coated with antibody specific for ferritin. The formation of the antibodyantigen complex during the reaction results in an increase in turbidity, the extent of which is measured as the amount of light absorbed at 658 nm. By constructing a standard curve from the absorbance of standards, ferritin concentration of a sample can be determined.
ADVIA Chemistry Liquid Specific Protein Calibrator is a multi-analyte, liquid, buffer based product containing multiple analytes derived from human sources. The kit consists of 6 vials each of 6 calibrator levels which are ready for use (no preparation is required). The constituent concentrations of these Calibrators are present at levels 2, 3, 4, 5 and 6. Level 1 is a zero level. The volume per vial is 1.0 mL. Values for the new lots are assigned from a master lot that is referenced to the WHO 3rd International Standard IBSC 94/572
The document describes the Siemens Healthcare Diagnostics Inc. ADVIA® Chemistry Ferritin (FRT) Reagent and ADVIA® Chemistry Liquid Specific Protein Calibrator. The study presented focuses on the Ferritin Reagent and its comparison to a predicate device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence are implicitly based on the correlation between the new device and the predicate device. The primary performance metric reported is a method comparison study.
| Acceptance Criteria | Reported Device Performance (ADVIA 1650 Chemistry Ferritin vs. N Latex Ferritin) |
|---|---|
| Close correlation to predicate device | Slope: 1.00 (95% CI: 0.97 – 1.03) |
| Intercept: 0.00 (95% CI: -3.4 – 3.4) |
The reported performance, with a slope of 1.00 and an intercept of 0.00 (both with narrow confidence intervals that include these ideal values), indicates a very strong correlation and agreement with the predicate device, thereby meeting the implicit acceptance criteria for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 47 patient samples
- Data Provenance: Not explicitly stated whether the samples were retrospective or prospective, nor their country of origin. The term "patient samples" is general.
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 document. The ground truth in this context is established by the measurements from the predicate device (N Latex Ferritin assay), which is an established, legally marketed device. There is no mention of experts establishing a separate ground truth for these samples.
4. Adjudication Method for the Test Set
This information is not applicable/provided. The study is a quantitative measurement comparison between two devices, not a diagnostic interpretation or classification that would typically involve an adjudication process by experts. Performance is determined by statistical correlation, not expert consensus on individual case interpretations.
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 information is not applicable/provided. This device is an in vitro diagnostic reagent and calibrator for automated chemistry systems, not an imaging or interpretive AI device that involves human readers/interpreters. Therefore, an MRMC study or AI assistance comparison is irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone study was done. The method comparison data presented is for the ADVIA 1650 Chemistry Ferritin assay (the new device) operating as an algorithm/system, without human interpretation influencing the measurement results directly. The output is a quantitative ferritin concentration.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the comparison study was effectively established by the predicate device's measurements (N Latex Ferritin assay). The new device's performance is being assessed against the established performance of the predicate device, assuming the predicate device provides accurate measurements within its validated range.
8. The Sample Size for the Training Set
This information is not provided in the document. The document describes a comparison study for a fully developed reagent and calibrator, not a software algorithm that typically undergoes a training phase with a distinct training set. The development of the assay itself would involve internal validation and optimization, but details of such a "training set" are not part of this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is largely not applicable in the context of a reagent-based IVD requiring predicate comparison. For the development and internal validation of such a system, ground truth would typically be established through highly accurate reference methods, certified reference materials, or correlation with established laboratory methods to ensure accuracy and precision. However, details of this process for the new device's internal development are not part of the publicly available 510(k) summary.
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Immunological in vitro immunoturbidometric test for the quantitative determination of ferritin in human serum and plasma using Roche/Hitachi clinical chemistry analyzers. Measurements obtained by this device are used in the aid of diagnosis of diseases affecting iron metabolism in conjunction with other clinical and laboratory findings.
The Tina-quant Ferritin Gen. 4 assay employs an immunoturbidimetric test in which human ferritin agglutinates with latex particles coated with anti-ferritin antibodies. The precipitate is determined turbidimetrically at 570/800 nm.
Here's a breakdown of the acceptance criteria and study information for the Tina-quant Ferritin Gen. 4 Assay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Implied) | Reported Device Performance (Tina-quant Ferritin Gen. 4 Assay) |
|---|---|---|
| Precision (Repeatability - Within Run %CV) | (Generally, 0.95 or similar Passing-Bablok parameters demonstrating equivalence) | Passing Bablok: y = 0.987x + 0.040, tau = 0.983; Linear regression: y = 0.987x + 0.591, r = 0.999 |
| Measuring Range | Roche/Hitachi 902: 5 - 800 ng/mL; Roche/Hitachi 912/917/Modular P: 5 - 1000 ng/mL | Roche/Hitachi 902: 5 - 800 ng/mL; Roche/Hitachi 912/917/Modular P: 5 - 1000 ng/mL |
Note on Acceptance Criteria: The provided text explicitly states the "reported device performance" and sometimes compares it to the predicate device's performance, but it does not explicitly define quantitative acceptance criteria for each metric. The "Acceptance Criteria (Implied)" column above reflects the common expectations for these types of assays and the comparison points given in the document. The fact that the device received 510(k) clearance implies that the reported performance met the FDA's requirements for substantial equivalence to the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Precision: The sample size for precision studies is not explicitly stated as a single number but lists 7 different samples (PNP, PPP, HS1-HS5) tested. For the predicate device's imprecision study, n=21. While "human samples and controls" are mentioned for the new device, specific numbers for each sample type are not provided beyond the samples tested.
- Method Comparison: 94 human serum and plasma samples.
- Interferences: No specific sample sizes for interference studies are provided; the results are reported as thresholds (e.g., "up to an I index of 60").
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only mentions "human samples and controls."
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)
This is an in vitro diagnostic (IVD) quantitative assay, not a device requiring expert interpretation of images or clinical data for ground truth. The "ground truth" for method comparison and precision in IVDs is typically established by measurements from a reference method (in this case, the predicate device) or by spiking known concentrations of the analyte. Therefore, the concept of "experts" establishing ground truth in the way described is not applicable here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human readers or interpretation requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is an in vitro diagnostic assay, not an imaging or clinical decision support AI device that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the studies described (Precision, Analytical Sensitivity, Functional Sensitivity, Analytical Specificity, Interferences, Method Comparison) are all standalone performance evaluations of the assay itself, without human-in-the-loop performance being a variable. The "algorithm" here is the biochemical reaction and the instrument's measurement system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Precision: Internal analysis using human samples and controls. The "ground truth" here is the mean concentration determined by repeated measurements of the same sample.
- Analytical Sensitivity: Established internally through method validation, typically by analyzing blank samples and low-concentration samples.
- Functional Sensitivity: Established internally, usually based on the lowest concentration at which acceptable precision (e.g.,
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DBF
The Ferritin Reagent is for the determination of ferritin concentrations in human serum and plasma on the Beckman Coulter family of AU clinical chemistry analyzers. For in vitro diagnostic use only.
Serum ferritin is an indicator of body iron stores: it has been shown to correlate with stainable bone marrow iron. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.
Not Found
This document is an FDA 510(k) clearance letter for the Beckman Coulter Ferritin Reagent (OSR61203). It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed study information, acceptance criteria, or performance data that you requested about the device.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This means the FDA found sufficient evidence that the new device performs as intended and is as safe and effective as a device already on the market. The specific details of how that substantial equivalence was demonstrated are typically found in the 510(k) submission itself, which is not provided in this public clearance letter.
Therefore, I cannot answer your questions based solely on the provided text. The document is primarily a formal notification of clearance, not a technical report of the studies performed.
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(67 days)
DBF
Medicon Ferritin - LATEX reagent is for the determination of Ferritin in human serum and plasma using automated clinical chemistry analyzers.
The measurement of ferritin may aid in the diagnosis of diseases affecting iron metabolism.
For in vitro diagnostic use.
The Ferritin – LATEX is an immunoturbidimetric assay. When serum or plasma specimen is mixed with the appropriate buffer (R1) and latex particles coated with anti-ferritin antibodies (R2), ferritin reacts with the antibodies leading to agglutination of latex particles. This agglutination is detected as turbidity change (600 nm) and it is proportional to ferritin concentration in the sample.
The Medicon Ferritin-LATEX device is an immunoturbidimetric assay for the quantitative determination of Ferritin in human serum and plasma using Olympus AU 400/600/640 automated clinical chemistry analyzers. The device's performance was compared to a predicate device, the Olympus Ferritin Reagent (K030124), to establish substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Medicon Ferritin-LATEX device are implicitly established by demonstrating substantial equivalence to the predicate device, the Olympus Ferritin Reagent (K030124). The performance characteristics are compared as follows:
| Feature | Acceptance Criteria (Predicate Device K030124) | Reported Device Performance (Medicon Ferritin-LATEX) |
|---|---|---|
| Measuring Range | 8-450 µg/L | 4-450 ng/ml |
| Sample type | Serum | Serum and plasma |
| Precision | ||
| Within run CV | 2.25% @ 40.0 ng/ml | |
| 2.00% @ 101 ng/ml | ||
| 1.25% @ 383 ng/ml | 3.20% @ 38.0 ng/ml | |
| 1.31% @ 108.1 ng/ml | ||
| 0.99% @ 224.1 ng/ml | ||
| Precision | ||
| Total CV | 3.43% @ 40.0 ng/ml | |
| 2.81% @ 101 ng/ml | ||
| 2.12% @ 383 ng/ml | 3.94% @ 38.0 ng/ml | |
| 1.62% @ 108.1 ng/ml | ||
| 1.43% @ 224.1 ng/ml | ||
| Analytical Sensitivity (LDL) | 6.4 µg/L | 4 ng/ml |
| Linearity | 8.0 - 450 µg/L | 4 - 450 ng/ml |
| Method Comparison (Correlation to commercially available ferritin assay) | y = 0.964x - 2.549 | |
| R = 0.995 | y = 1.0016x + 4.3849 | |
| R = 0.9958 | ||
| Interferences | ||
| Haemolysis | ||
| Lipemic | ||
| Icterus | ||
| Rheumatoid Factor | Less than 10% up to 5 g/L hemoglobin | |
| Less than 10% up to 400mg/dL Intralipid® | ||
| Less than 5% up to 40mg/dL or 684 µmol/l bilirubin | ||
| Less than 5% up to 500 IU/ml RF | Less than 5% up to 500 mg/dl hemoglobin | |
| Less than 10% up to 400mg/L Intralipid® | ||
| Less than 5% up to 20mg/dl bilirubin | ||
| Less than 5% up to 900 IU/ml RF | ||
| Ascorbic acid: Less than 5% up to 3 mg/dl ascorbic acid | ||
| Prozone Effect | No hook effect observed up to 5000 ng/ml | No hook effect observed up to 10000 ng/ml |
| Reagent Stability (On board) | 30 days | 30 days |
| Calibration Interval | After each lot and 14 days | After each lot and 14 days |
| Traceability/Standardization | Standardized against the 3rd International Standard for ferritin, Recombinant NBSC code:94/572 | Standardized against the 3rd International Standard for ferritin, Recombinant NBSC code:94/572 |
Note on Units: The predicate device uses µg/L, and the new device uses ng/ml. While numerically equivalent (1 µg/L = 1 ng/ml), this is a difference in units presentation in the provided summary. For clarity in the table, the units as presented in the original text are retained.
Study Proving Device Meets Acceptance Criteria:
The study submitted for premarket notification K062746 comprised a series of analytical performance tests designed to demonstrate substantial equivalence to the predicate Olympus Ferritin Reagent (K030124). These tests included:
- Measuring Range/Linearity: Evaluation of the device's ability to accurately measure ferritin concentrations across its claimed range.
- Precision: Assessment of the reproducibility and repeatability of measurements (within-run and total CV).
- Analytical Sensitivity (Lower Detection Limit - LDL): Determination of the lowest concentration of ferritin that can be reliably detected.
- Method Comparison: Correlation of results from the Medicon Ferritin-LATEX with a "commercially available ferritin assay" using patient samples. Additionally, comparisons were made between serum and plasma samples using the Medicon Ferritin-LATEX.
- Interference Testing: Evaluation of the effect of potential interferents (hemolysis, lipemia, icterus, rheumatoid factor, ascorbic acid) on assay accuracy.
- Prozone Effect: Assessment of high-dose hook effect.
- Reagent Stability and Calibration Interval: Verification of the claimed stability and calibration requirements.
- Traceability/Standardization: Confirmation of standardization against recognized international standards.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Method Comparison (Ferritin-LATEX vs. commercially available ferritin assay): The summary states "patient serum samples," but the exact number of samples is not specified.
- Method Comparison (Ferritin-LATEX: serum vs. EDTA plasma): The summary states "patient serum and EDTA plasma," but the exact number of samples is not specified.
- Method Comparison (Ferritin-LATEX: serum vs. Li-Heparine plasma): The summary states "patient serum and Li-Heparine plasma," but the exact number of samples is not specified.
- Precision: Data is reported for 3 levels (38.0 ng/ml, 108.1 ng/ml, 224.1 ng/ml), implying multiple replicates were tested at each level to calculate CVs, but the total number of samples or runs is not explicitly stated.
- Interference: Concentrations for various interferents are provided, suggesting samples spiked with these substances were tested, but the number of samples is not specified.
- Prozone Effect: Samples up to 10000 ng/ml were tested, but the number of samples is not specified.
- Data Provenance: The document does not explicitly state the country of origin of the data. Given the "Medicon Hellas S.A." submitter information (Greece), it is plausible the studies were conducted in Greece or Europe, but this is not confirmed. The data appears to be from retrospective clinical samples (patient serum/plasma samples) and controlled laboratory studies (spiking experiments for interference, known concentrations for precision and linearity).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
For an in vitro diagnostic device like a Ferritin assay, ground truth is typically established through reference methods or established laboratory practices rather than expert consensus on interpretation.
- No "experts" in the sense of clinicians or radiologists interpreting images were involved in establishing ground truth for individual test samples.
- The ground truth for the method comparison study was established by another "commercially available ferritin assay." This assay itself would have been validated against a reference method or known standards.
- The predicate device and the new device are both stated to be "Standardized against the 3rd International Standard for ferritin, Recombinant NBSC code: 94/572." This international standard serves as the ultimate ground truth for ferritin concentration measurements.
4. Adjudication Method for the Test Set
Not applicable. As described above, the ground truth for this in vitro diagnostic device is based on quantitative measurements against an international standard and comparison to a legally marketed predicate device, not on expert consensus or adjudication of subjective interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is an in vitro diagnostic device (a reagent for an automated clinical chemistry analyzer) and not an imaging or interpretive device that would typically involve human readers. Therefore, an MRMC study is not relevant or performed for this type of device.
6. Standalone Performance
Yes, the studies described (Precision, Analytical Sensitivity, Linearity, Interference, Prozone Effect) are all assessments of the standalone performance of the Medicon Ferritin-LATEX algorithm/reagent system on an automated analyzer. The method comparison studies also demonstrate the standalone performance against an existing method. The entire submission focuses on the performance of the device without human interpretation of the assay results, relying instead on the quantitative output of the automated analyzer.
7. Type of Ground Truth Used
The ground truth used is primarily:
- Reference Standards: The device is standardized against the "3rd International Standard for ferritin, Recombinant NBSC code:94/572." This is the fundamental ground truth for ferritin concentration.
- Comparative Reference Method: For method comparison, another "commercially available ferritin assay" served as the reference method, which itself would have been validated against standards.
- Known Concentrations: For studies like precision and linearity, samples with known or spiked concentrations were used against which the device's measurements were assessed.
8. Sample Size for the Training Set
The provided 510(k) summary does not contain information on a "training set" in the context of machine learning. This device is a biochemical reagent system, not an AI or machine-learning algorithm that typically requires a large training dataset. The development and optimization of such a reagent assay would involve internal development testing, but this is distinct from a "training set" as understood in AI/ML contexts.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a "training set" or AI/ML components in this 510(k) submission for a biochemical reagent. The ground truth for the device's development and validation would have been established using the accepted methods for in vitro diagnostics, as outlined in point 7.
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DBF
For in vitro diagnostic use only. The RDI Ferritin Kit is for the quantitative determination of Ferritin in luman serum or plasma by immunoturbidimetric measurement.
Measurement of ferritin is useful in assessing iron stores and in the evaluation of iron deficiency anemia and hemochromatosis.
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The provided text is a summary of a premarket notification for the RDI Ferritin Kit, which is an in vitro diagnostic device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document primarily focuses on:
- Device Name: RDI Ferritin Kit
- Regulation Information: 21 CFR § 866.5340, Regulation Name: Ferritin Immunological Test System, Regulatory Class: II, Product Code: DBF
- FDA Determination: Substantial equivalence to legally marketed predicate devices, allowing the device to be marketed.
- Indications for Use: Quantitative determination of Ferritin in human serum or plasma by immunoturbidimetric measurement, useful in assessing iron stores and evaluating iron deficiency anemia and hemochromatosis.
Therefore, I cannot provide the requested information as it is not present in the given text.
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