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510(k) Data Aggregation
(210 days)
TINA-QUANT ALBUMIN GEN.2
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.
-
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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(134 days)
TINA-QUANT ALBUMIN GEN 2
The Tina-quant Albumin Gen. 2 assay is an immunoturbidimetric assay intended for the quantitative determination of albumin in serum, plasma, urine, and CSF on Roche/Hitachi cobas c systems. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.
The Tina-quant Albumin Gen. 2 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, serum, plasma and CSF on Roche/Hitachi cobas c systems.
Here's an analysis of the acceptance criteria and the studies performed, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents separate substantial equivalence comparisons for the urine, serum/plasma, and CSF applications of the Tina-quant Albumin Gen. 2 assay against predicate devices. The "acceptance criteria" are implied by the measured performance parameters, as they are being compared to the predicate device and found to be substantially equivalent.
Table 1: Urine Application Performance Comparison
| Feature | Acceptance Criteria (Predicate: Hitachi Microalbumin Urine Assay - K932950) | Reported Device Performance (Tina-quant Albumin Gen. 2 - Urine Application) |
|---|---|---|
| Precision | ||
| Within-run (mg/L) | Mean = 9.0, SD = 0.29, CV = 3.2% | Mean = 30.7, SD = 0.2, CV = 0.8% |
| Mean = 22.1, SD = 0.30, CV = 1.4% | Mean = 108, SD = 1, CV = 0.7% | |
| Mean = 81.1, SD = 0.67, CV = 0.8% | Mean = 14.3, SD = 0.2, CV = 1.6% | |
| Mean = 252 mg/L, SD = 4, CV = 1.6% | ||
| Total (mg/L) | Mean = 9.0, SD = 0.92, CV = 10.1% | Mean = 31.2, SD = 0.5, CV = 1.7% |
| Mean = 22.1, SD = 1.15, CV = 5.2% | Mean = 105, SD = 1, CV = 1.2% | |
| Mean = 81.1, SD = 0.78, CV = 1.0% | Mean = 13.6, SD = 0.4, CV = 2.8% | |
| Mean = 60.6, SD = 1.4, CV = 2.3% | ||
| Analytical Sensitivity | Lower Detection Limit = 3 mg/L | LoB = 2 mg/L, LoD = 3 mg/L, LoQ = 12 mg/L |
| Analytical Specificity | No interference from 18 common drugs | No interference at common therapeutic concentrations |
| No unflagged high-dose hook effect up to 40000 mg/L | ||
| Interferences | Criterion: Recovery within ± 10% | |
| Icterus | No significant interference up to 25 mg/dL | No significant interference up to I index of 50 (approx. 50 mg/dL conjugated bilirubin) |
| Hemolysis | Hemoglobin levels >300 mg/dL cause significant positive interference | No significant interference up to H index of 400 (approx. 400 mg/dL hemoglobin) |
| Lipemia | No significant interference up to an L index of 200 | No interference by acetone, ammonia chloride, calcium, creatinine, y-globulin, glucose, urea, uric acid, urobilinogen (specific concentrations given) |
| Method Comparison | Linear Regression: y = 1.028x - 4.13 mg/L, r = 0.999 | Passing Bablock: y = 1.023x + 3.64 mg/L, $\tau$ = 0.984 |
| (Predicate on Hitachi 917 analyzer) | (Tina-quant on c501 analyzer vs. Hitachi Microalbumin on Hitachi 917) |
Table 2: Serum/Plasma Application Performance Comparison
| Feature | Acceptance Criteria (Predicate: Behring N Antiserum to Human Albumin Assay - K972929) | Reported Device Performance (Tina-quant Albumin Gen. 2 - Serum/Plasma Application) |
|---|---|---|
| Precision | ||
| Intra-assay (g/L) | Mean: 46.5; CV: 4.3% | |
| Inter-assay (g/L) | Mean: 44.7; CV: 4.4% | |
| Repeatability (Within-run) (mg/L) | Not directly comparable, but predicate shows ~4% CV | Mean = 39.9, SD = 0.5, CV = 1.2% |
| Mean = 66.6, SD = 1.4, CV = 1.2% | ||
| Mean = 27.6, SD = 0.4, CV = 1.3% | ||
| Mean = 62.5 mg/L, SD = 0.9, CV = 1.5% | ||
| Intermediate Precision (Total) (mg/L) | Not directly comparable, but predicate shows ~4% CV | Mean = 42.3, SD = 0.9, CV = 2.0% |
| Mean = 70.5, SD = 1.6, CV = 2.2% | ||
| Mean = 7.78, SD = 0.74, CV = 9.5% | ||
| Mean = 36.2, SD = 0.7, CV = 2.1% | ||
| Analytical Sensitivity | Established by lower limit of reference curve, depends on protein concentrations | LoB = 1 g/dL, LoD = 2 g/dL, LoQ = 3 g/dL |
| Analytical Specificity | No interference from commonly used drugs is known. | No interference at common therapeutic concentrations |
| Interferences | Turbidity and particles may interfere. Bovine serum albumin may disturb. | Criterion: Recovery within ± 10% |
| Icterus | Not specified in detail, but general interference noted. | No significant interference up to I index of 60 (approx. 60 mg/dL conjugated bilirubin) |
| Hemolysis | Not specified in detail, but general interference noted. | No significant interference up to H index of 1000 (approx. 1000 mg/dL hemoglobin) |
| Lipemia | Not specified in detail, but general interference noted. | No significant interference up to L index of 1500 (approx. 1500 mg/dL intralipid) |
| Rheumatoid factors | Not specified. | ≤ 1200 IU/mL do not interfere. |
| Method Comparison | Predicate calibrates by serial dilutions | Passing Bablock: y = -0.1320 + 0.9600x, $\tau$ = 0.919 |
| Linear Regression (provided): y = -0.0095 + 0.9572x, r = 0.993 | ||
| (Tina-quant on c501 analyzer vs. nephelometric Albumin test) | (Tina-quant on c501 analyzer vs. nephelometric Albumin test) |
Table 3: CSF Application Performance Comparison
| Feature | Acceptance Criteria (Predicate: Behring N Antiserum to Human Albumin Assay - K972929) | Reported Device Performance (Tina-quant Albumin Gen. 2 - CSF Application) |
|---|---|---|
| Precision | Not specified for CSF in predicate. | |
| Repeatability (Within-run) (mg/L) | Mean = 99.2, SD = 1.4, CV = 1.4% | |
| Mean = 174, SD = 3, CV = 1.7% | ||
| Mean = 383, SD = 4, CV = 1.0% | ||
| Mean = 454 mg/L, SD = 4, CV = 0.8% | ||
| Intermediate Precision (Total) (mg/L) | Mean = 91.0, SD = 2.9, CV = 3.2% | |
| Mean = 389, SD = 7, CV = 1.7% | ||
| Mean = 166, SD = 4, CV = 2.3% | ||
| Mean = 366, SD = 5, CV = 1.3% | ||
| Analytical Sensitivity | Established by lower limit of reference curve, depends on protein concentrations | LoB = 20 mg/L, LoD = 36 mg/L, LoQ = 95 mg/L |
| Analytical Specificity | No interference from commonly used drugs is known. | No interference at common therapeutic concentrations |
| Interferences | Not specified for CSF. | Criterion: Recovery within ± 10% |
| Hemolysis | No significant interference up to H index of 1000 (approx. 1000 mg/dL hemoglobin) | |
| Icterus | No significant interference up to I index 60 (approx. 600 mg/L conjugated and unconjugated bilirubin) | |
| High dose hook-effect | No false result without a flag up to 30000 mg/L albumin concentration | |
| Method Comparison | Predicate calibrates by serial dilutions. | Passing Bablock: y = 1.000x - 8.75 mg/L, $\tau$ = 0.936 |
| Linear Regression (provided): y = 0.991x + 0.301 mg/L, r = 0.992 | ||
| (Tina-quant on c501 analyzer vs. nephelometric Albumin test) | (Tina-quant on c501 analyzer vs. nephelometric Albumin test) |
2. Sample Size Used for the Test Set and Data Provenance
-
Urine Application Method Comparison:
- Sample Size: n = 125
- Provenance: Not explicitly stated (e.g., country of origin, prospective/retrospective). The comparison is between the Tina-quant Albumin Gen. 2 assay on the c501 analyzer and the Hitachi Microalbumin assay on the Hitachi 917 analyzer (K953239). The sample concentrations were between 12.3 and 386 mg/L.
-
Serum/Plasma Application Method Comparison:
- Sample Size: n = 77
- Provenance: Not explicitly stated. The comparison is between the Tina-quant Albumin Gen. 2 assay on the cobas c501 analyzer and a nephelometric Albumin test. The sample concentrations were between 5.70 and 100 g/L.
-
CSF Application Method Comparison:
- Sample Size: n = 85
- Provenance: Not explicitly stated. The comparison is between the Tina-quant Albumin Gen. 2 assay on the cobas c501 analyzer and a nephelometric Albumin test. The sample concentrations were between 115 and 2640 mg/L.
-
Precision, Sensitivity, Specificity, Interferences:
- The sample sizes for these internal studies are not explicitly mentioned in the provided text for each specific test, but they are implied to be sufficient for analytical validation. Provenance is also not explicitly stated.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
- The document describes an in-vitro diagnostic device for quantitative determination of albumin. The "ground truth" here is the actual albumin concentration in the samples, established by reference methods or predicate devices, rather than expert interpretation of images or other subjective data.
- Therefore, the concept of "experts" to establish a subjective ground truth (like radiologists for imaging) is not directly applicable to this type of analytical device. The references are to other cleared devices (predicate devices) or established analytical methods.
4. Adjudication Method for the Test Set
- As the device provides a quantitative measurement, and the "ground truth" is established by a reference method or predicate device performance, there is no mention of an "adjudication method" in the sense of reconciling differences between multiple human interpreters. This concept is typically relevant for subjective assessments (e.g., medical image interpretation).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This type of study is relevant for devices that assist human readers (e.g., AI in radiology). The Tina-quant Albumin Gen. 2 assay is a standalone diagnostic test performed by an automated analyzer, not an assistive technology for human interpreters.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- Yes, the performance data presented is for the standalone device (Tina-quant Albumin Gen. 2 assay on the Roche/Hitachi cobas c systems) without human intervention for the measurement itself. The results are quantitative values generated by the automated system. The accuracy is assessed by correlation with predicate devices/methods.
7. The Type of Ground Truth Used
- The ground truth for the performance studies (specifically method comparisons) was established by comparison to existing, legally marketed predicate devices or established nephelometric albumin tests. This implies that the predicate devices/methods themselves served as the reference standard for the "true" albumin values in the samples.
8. The Sample Size for the Training Set
- The document describes a 510(k) submission for substantial equivalence. This is for a conventional in-vitro diagnostic (IVD) assay, not a machine learning or AI-based device that typically involves "training sets." Therefore, the concept of a "training set" in the context of machine learning is not applicable here. The assay relies on established immunoturbidimetric principles, and performance is validated through analytical studies on test samples.
9. How the Ground Truth for the Training Set Was Established
- As explained in point 8, the concept of a "training set" is not applicable to this device submission.
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