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510(k) Data Aggregation
(210 days)
The Tina-quant Albumin Gen.2 assay is an immunoturbidimetric assay intended for the quantitative determination of albumin in human urine on Roche/Hitachi cobas c systems. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.
The Tina-quant Albumin Gen. 2 - cobas c 311 urine assay employs an immunoturbidimetric test in which anti-albumin antibodies react with the antigen in the sample to form antigen/antibody complexes which, following agglutination are determined turbidimetrically.
The provided document describes the Tina-quant Albumin Gen. 2 Assay, an immunoturbidimetric test for quantitative determination of albumin in human urine. The submission primarily focuses on establishing substantial equivalence to a previously cleared device (Tina-quant Albumin Gen.2 - cobas c 501 urine assay, K101203).
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a separate section. Instead, performance characteristics of the new device (Tina-quant Albumin Gen. 2 - cobas c 311 urine assay) are presented and compared against those of the predicate device (Tina-quant Albumin Gen. 2 - cobas c 501 urine assay) to demonstrate substantial equivalence. The implication is that the performance of the new device aligns sufficiently with the predicate.
Here's a table summarizing the reported device performance, with the understanding that these values are being compared for substantial equivalence and implicitly serve as acceptable performance benchmarks based on the predicate device.
| Feature | Implicit Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Tina-quant Albumin Gen. 2 - cobas c 311) |
|---|---|---|
| Measuring Range | 12-400 mg/L | 12-200 mg/L |
| Precision (Repeatability) | ||
| - Level 1 (e.g., 30.7 mg/L) | SD = 0.2, CV = 0.8% | Mean = 32.0, SD = 0.2, CV = 0.7% |
| - Level 2 (e.g., 108 mg/L) | SD = 1, CV = 0.7% | Mean = 101, SD = 1, CV = 1.2% |
| - Level 3 (e.g., 14.3 mg/L) | SD = 0.2, CV = 1.6% | Mean = 10.7, SD = 0.2, CV = 2.2% |
| - Level 4 (e.g., 252 mg/L) | SD = 4, CV = 1.6% | Mean = 132, SD = 2, CV = 1.9% |
| Precision (Intermediate Precision) | ||
| - Level 1 (e.g., 31.2 mg/L) | SD = 0.5, CV = 1.7% | Mean = 31.3, SD = 0.6, CV = 1.9% |
| - Level 2 (e.g., 105 mg/L) | SD = 1, CV = 1.2% | Mean = 97.9, SD = 0.7, CV = 0.7% |
| - Level 3 (e.g., 13.6 mg/L) | SD = 0.4, CV = 2.8% | Mean = 13.6, SD = 0.4, CV = 2.9% |
| - Level 4 (e.g., 60.6 mg/L) | SD = 1.4, CV = 2.3% | Mean = 63.7, SD = 0.7, CV = 1.1% |
| Analytical Sensitivity | ||
| - Limit of Blank (LoB) | 2 mg/L | 2 mg/L |
| - Limit of Detection (LoD) | 3 mg/L | 3 mg/L |
| - Limit of Quantitation (LoQ) | 12 mg/L | 12 mg/L |
| Analytical Specificity | No interference at therapeutic concentrations; no false result without flag up to 40000 mg/L Albumin | No interference at therapeutic concentrations; no false result without flag up to 40000 mg/L Albumin |
| Interferences | Recovery within ± 10% (for icterus, hemolysis, certain substances) | Recovery within ± 10% (for icterus, hemolysis, certain substances) |
| Method Comparison | Linear regression: y = 1.038x - 1.066 mg/L, r = 0.999 | Passing Bablock: y = 1.036x + 0.415 mg/L, $\tau$ = 0.972 |
Note: For many features (Assay Protocol, Sample Type, Calibrator, Calibration Frequency, Controls, Reagent Stability, Analytical Specificity, and Interferences), the predicate device's performance implicitly serves as the acceptance criterion, and the new device is stated to be "Same" or to have met the same criteria.
The measuring range of the new device (12-200 mg/L) is narrower than the predicate (12-400 mg/L), but this difference is not flagged as a concern for substantial equivalence in the document.
2. Sample Size Used for the Test Set and Data Provenance:
-
Method Comparison:
- Sample Size: n = 69
- Data Provenance: Not explicitly stated (e.g., country of origin). The document states "human urine samples," but does not specify if they were collected retrospectively or prospectively.
-
Precision (Repeatability & Intermediate Precision): The sample sizes for these studies are not explicitly stated, nor is the data provenance. Usually, these involve multiple runs and replicates of control or spiked samples.
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Analytical Sensitivity, Specificity, and Interferences: Sample sizes and data provenance are not provided for these studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The studies performed (method comparison, precision, analytical sensitivity, specificity, interferences) are laboratory-based and involve technical measurements rather than interpretations by medical experts for establishing ground truth in the traditional sense of diagnostic imaging or clinical decision-making.
4. Adjudication Method for the Test Set:
This information is not applicable or not provided. The studies detailed are analytical performance studies of a laboratory assay, not studies requiring expert adjudication methods like 2+1 or 3+1 that are common in diagnostic imaging or clinical studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance:
This information is not applicable. The device is an in vitro diagnostic assay (a laboratory test) and does not involve human readers interpreting images or data that would be assisted by AI. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
This information is not applicable in the context of AI. The device itself is an automated immunoturbidimetric assay on an instrument (cobas c 311). Its performance, as described by precision, sensitivity, specificity, and method comparison, represents the "standalone" or "algorithm only" performance of the assay on the instrument without human interpretation of raw data. There is no AI component that would require a separate "human-in-the-loop" study.
7. The Type of Ground Truth Used:
- Method Comparison: The "ground truth" for the method comparison study is implicitly the measurement obtained from the predicate device (Tina-quant Albumin Gen. 2 - cobas c 501 assay, K101203). The study compares the new device's results against the predicate device's results.
- Precision: Ground truth is established by the known concentrations of control or spiked samples used in the precision studies.
- Analytical Sensitivity: Ground truth for LoB, LoD, and LoQ is determined through statistical analysis of blank and low-concentration samples.
- Analytical Specificity and Interferences: Ground truth is established by known concentrations of interfering substances added to samples, and observing the recovery of the albumin measurement.
8. The Sample Size for the Training Set:
This information is not provided and is not applicable in the context of this device. The Tina-quant Albumin Gen. 2 Assay is a chemical/immunological assay, not a machine learning or AI-based device that requires a "training set." The assay relies on established chemical reactions and optical detection, not an algorithm that learns from data.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the reasons stated in point 8.
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