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510(k) Data Aggregation
(21 days)
Immunoturbidimetric assay for the quantitative in vitro determination of IgG in human serum, plasma and cerebrospinal fluid (CSF) on Roche automated clinical chemistry analyzers. Measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
The Tina-Quant ® IgG Gen.2 is an immunoturbidimetric assay for the quantitative in vitro determination of IgG in human serum, plasma and cerebrospinal fluid (CSF). Anti-IgG antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically. The assay contains a standard application for measurement of IgG in human serum and plasma and a sensitive application for measurement of IgG in CSF.
The document describes the Tina-Quant IgG Gen.2 device, an immunoturbidimetric assay for the quantitative determination of IgG in human serum, plasma, and cerebrospinal fluid (CSF). The following information is extracted regarding its acceptance criteria and the study that proves it meets these criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device and the performance characteristics presented. The key performance characteristics are:
| Performance Characteristic | Acceptance Criteria (Implied by Predicate/Clinical Relevance) | Reported Device Performance (Tina-Quant IgG Gen.2) | Predicate Device Performance (Dade-Behring N Antisera IgG on BN II) |
|---|---|---|---|
| Measuring Range (CSF) | Relevant range for clinical diagnosis of abnormal protein metabolism and infectious agents, comparable to predicate. | 2.0 - 200 mg/L; 2-1000 mg/L with rerun | Depends on concentration of proteins in N Protein Standard SL |
| Expected Values for IgG in CSF | Clinically acceptable range, comparable to predicate. | 10-30 mg/L (according to CRM 470 standardization) | Below 34 mg/L (with reference to CRM 470) |
| Precision (CSF) | Low Coefficients of Variation (CVs) for reliable measurements. | Within-run CV: 5.74% @ 11.7 mg/L human CSF Between-run CV: 6.52% @ 13.21 mg/L human CSF | Note: no separate values are given for CSF precision |
| Analytical Sensitivity | Low limit of detection for accurate measurement of low IgG levels. | 2 mg/L | Established by lower limit of reference curve; depends on concentration of proteins in N Protein Standard SL |
| Method Comparison (CSF) | Strong correlation and agreement with a legally marketed predicate device (slope close to 1, intercept close to 0, high r-value). | Slope = 1.042, Intercept = -3.903, r = 0.988 (54 samples, 6.17-65.5 mg/L) | N/A (this is the comparison to the predicate) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- For the Method Comparison study, 54 samples were used for CSF.
- For Precision, various control sera and human CSF samples were used, with specific concentrations mentioned (e.g., 11.7 mg/L human CSF, 13.21 mg/L human CSF for precision studies). The exact number of samples for each precision test is not explicitly stated as a single total, but rather the results for specific concentrations/controls.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The studies described are analytical performance studies comparing the new device to a predicate device and assessing within-device performance characteristics, not studies relying on expert ground truth for interpretation of clinical findings.
4. Adjudication Method for the Test Set
This information is not applicable to the type of analytical performance studies described in the document. No adjudication method is mentioned as there were no subjective interpretations requiring consensus.
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 to the Tina-Quant IgG Gen.2 device, as it is an in vitro diagnostic assay (a chemical analyzer) and not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance data presented (measuring range, precision, sensitivity, method comparison) reflects the standalone performance of the Tina-Quant IgG Gen.2 assay as an automated in vitro diagnostic test. This device does not incorporate a human-in-the-loop component for its primary function of quantitative IgG determination.
7. The Type of Ground Truth Used
The "ground truth" for the performance studies of the Tina-Quant IgG Gen.2 device is established by:
- Traceability/Standardization: To CRM 470, a certified reference material. This provides a universally accepted standard for IgG measurement.
- Comparison to a Legally Marketed Predicate Device: The Dade-Behring N Antisera to Human Immunoglobulins IgG on BN II device, which is already established and accepted in the market.
Therefore, the "ground truth" is based on standardized reference materials and the performance of an established, legally marketed predicate device.
8. The Sample Size for the Training Set
This information is not applicable. The Tina-Quant IgG Gen.2 is a chemical assay, not a machine learning or AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this type of device.
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