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510(k) Data Aggregation
(117 days)
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, < 10% for low concentrations, < 5% for higher concentrations) | PNP: 0.9% CV (Mean 128 ng/mL) |
| PPP: 1.2% CV (Mean 332 ng/mL) | ||
| HS1: 7.2% CV (Mean 8.48 ng/mL) | ||
| HS2: 4.7% CV (Mean 25.5 ng/mL) | ||
| HS3: 0.9% CV (Mean 235 ng/mL) | ||
| HS4: 1.2% CV (Mean 619 ng/mL) | ||
| HS5: 1.1% CV (Mean 820 ng/mL) | ||
| Precision (Intermediate Precision - Between Day %CV) | (Generally, < 15% for low concentrations, < 10% for higher concentrations) | PNP: 1.5% CV (Mean 128 ng/mL) |
| PPP: 2.0% CV (Mean 332 ng/mL) | ||
| HS1: 9.9% CV (Mean 8.48 ng/mL) | ||
| HS2: 5.2% CV (Mean 25.5 ng/mL) | ||
| HS3: 1.8% CV (Mean 235 ng/mL) | ||
| HS4: 2.1% CV (Mean 619 ng/mL) | ||
| HS5: 2.1% CV (Mean 820 ng/mL) | ||
| Analytical Sensitivity (Limit of Blank) | (Lower than any clinically relevant value) | 3 ng/mL |
| Analytical Sensitivity (Limit of Detection) | (Lower than any clinically relevant value) | 5 ng/mL |
| Functional Sensitivity (Limit of Quantitation) | (Lower than any clinically relevant value, usually above LoD) | 7 ng/mL |
| Interference (Icterus) | No significant interference up to I index of 60 mg/dL | No significant interference up to an I index of 60 (approx. 60 mg/dL bilirubin) |
| Interference (Hemolysis) | No significant interference up to H index of 500 mg/dL | No significant interference up to an H index of 500 (approx. 500 mg/dL hemoglobin) |
| Interference (Lipemia) | No significant interference up to Intralipid concentration of 1000 mg/dL (on 912/917/MODULAR P) and 800 mg/dL (on 902) | No significant interference up to an Intralipid concentration of 1000 mg/dL on Roche/Hitachi 912, 917 and MODULAR P analyzers and up to an Intralipid concentration of 800 mg/dL on Roche/Hitachi 902 analyzers. |
| Interference (Rheumatoid factors) | No interference for RF < 1200 IU/ml | Rheumatoid factors < 1200 IU/ml do not interfere. |
| High-dose Hook Effect | No high-dose hook effect within a relevant assay range | No high-dose hook effect is seen up to a ferritin concentration of 80000 ng/mL on Roche/Hitachi 902/912/917/MODULAR P analyzers. |
| Method Comparison (Correlation with Predicate Device) | Strong correlation (e.g., r > 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., <20% CV) is achieved.
- Method Comparison: The predicate device (Tina-Quant Ferritin assay cleared in K964282) on the same analyzer was used as the reference method. So, the "ground truth" for comparison was the results generated by the predicate device.
8. The sample size for the training set
This is an IVD assay, not a machine learning model. Therefore, the concept of a "training set" in that context does not apply. The development process for such an assay involves various R&D experiments and optimization over time, but not a distinct "training set" in the AI sense.
9. How the ground truth for the training set was established
Not applicable, as there is no training set in the context of a machine learning model.
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