Search Results
Found 1 results
510(k) Data Aggregation
(95 days)
CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH
Cystatin C is intended for quantitative in-vitro diagnostic determination of Cystatin C in human serum or Li-heparin plasma and EDTA plasma by turbidimetry using T60 Clinical Chemistry Analyzers.
Cystatin C measurements in serum and plasma are used as an aid in the diagnosis and treatment of renal diseases.
Cystatin C Calibrator is intended for in vitro diagnostic use on T60 analyzer. Cystatin C Calibrator is used as a calibrator for quantification of Cystatin C in serum and plasma by immunoturbidimetry using methods defined by Thermo Electron Oy.
Cystatin C Control is intended for in vitro diagnostic use on T60 analyzer. Cystatin C Control is used as a quality control to monitor precision of the Cystatin C test using methods defined by Thermo Electron Oy.
Cystatin C Control High is intended for in vitro diagnostic use on T60 analyzer. Cystatin C Control High is used as a quality control serum to monitor precision of the Cystatin C test using methods defined by Thermo Electron Oy.
Not Found
The provided text describes the 510(k) summary for the Thermo Electron Oy CYSTATIN C diagnostic kit. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing a specific study to meet acceptance criteria for a novel device. However, some performance characteristics are reported that can be considered as addressing acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria are not explicitly stated for individual metrics. Instead, the approach is to demonstrate comparability to a legally marketed predicate device (Dako Cystatin C reagent). The document outlines several performance characteristics, and the implicit acceptance criterion is that the new device's performance should be similar or equivalent to the predicate device.
| Performance Attribute | Acceptance Criteria (Implicit - based on predicate) | Reported New Device Performance (Thermo Electron Oy CYSTATIN C) |
|---|---|---|
| Intended Use | Quantitative determination of Cystatin C in human serum, heparinized plasma, and EDTA plasma by turbidimetry and nephelometry; aid in diagnosis and treatment of renal diseases. | Quantitative determination of Cystatin C in human serum, Li-heparin plasma, and EDTA plasma on T60 analyzer; aid in diagnosis and treatment of renal diseases. |
| Assay Protocol | Particle enhanced immunoturbidimetric | Particle enhanced immunoturbidimetric |
| Traceability/Standardization | Traceability to pure recombinant Cystatin C preparation by dry mass determination. | Traceability to pure recombinant Cystatin C preparation by dry mass determination. |
| Sample Type | Human serum, heparinized plasma, EDTA plasma | Human serum, Li-heparin plasma, EDTA plasma |
| Reagent Storage | Store at 2°C - 8°C. | Store at 2°C - 8°C. |
| Expected Values | Individuals 1-50 years: 0.55-1.15 mg/L; >50 years: 0.63-1.44 mg/L | Individuals 1-50 years: 0.55-1.15 mg/L; >50 years: 0.63-1.44 mg/L |
| Measuring Range | ~0.4-7.5 mg/L | 0.44 - 7.0 mg/L |
| Precision (Within run, CV%) | Predicate provides total CV% ranges from 2.1% to 5.9% | Level 0.70 mg/L: 1.4%; Level 1.49 mg/L: 2.6%; Cystatin C Control: 2.7%; Cystatin C High Control: 1.2% |
| Precision (Between run, CV%) | Predicate provides total CV% ranges from 2.1% to 5.9% | Level 0.70 mg/L: 1.5%; Level 1.49 mg/L: 0.4%; Cystatin C Control: 3.1%; Cystatin C High Control: 0.8% |
| Precision (Total, CV%) | Predicate provides total CV% ranges from 2.1% to 5.9% | Level 0.70 mg/L: 2.3%; Level 1.49 mg/L: 2.6%; Cystatin C Control: 4.2%; Cystatin C High Control: 1.6% |
| Method Comparison (Correlation with Predicate) | High correlation (e.g., r ≥ 0.98), slope close to 1, intercept close to 0. | $y = 0.94x + 0.091$, $r = 0.9988$ (Range 0.21 to 6.58 mg/L, n = 54) |
| Interferences (Lipemia) | No interference up to 1500 mg/dL triglycerides. | No interference up to 800 mg/dL Intralipid™; No interference up to 1500 mg/dL triglycerides. |
| Interferences (Hemoglobin) | No interference up to 1000 mg/dL. | No interference up to 1000 mg/dL. |
| Interferences (Bilirubin, conjugated) | No interference up to 60 mg/dL. | No interference up to 58.5 mg/dL. |
| Interferences (Bilirubin, unconjugated) | No interference up to 60 mg/dL. | No interference up to 58.5 mg/dL. |
| Interferences (Rheumatoid factor) | No interference up to 1200 IU/mL. | No interference was found up to (value truncated in document). |
2. Sample size used for the test set and the data provenance
- Method Comparison:
n = 54samples were used for the method comparison study with the predicate device. - Precision: The sample sizes for the precision studies (within-run, between-run, total) are not explicitly stated, but results are given for specific "Levels" (e.g., 0.70 mg/L, 1.49 mg/L) and "Controls" (Cystatin C Control, Cystatin C High Control). Typically, precision studies involve running multiple replicates of these samples over several days/runs.
- Interference: No specific sample size is given for interference studies, but it's implied that studies were performed to determine the interference limits for various substances.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the submitter's address is Finland, the studies were likely conducted there or in collaboration with Finnish institutions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For an in vitro diagnostic device like this, "ground truth" would typically refer to the true concentration of Cystatin C in the samples. This is usually established through highly accurate reference methods or certified reference materials, not by expert consensus in the same way an imaging device might use radiologists. The document mentions traceability to "a pure recombinant Cystatin C preparation, where the Cystatin C concentration was established by dry mass determination," which serves as the ultimate reference for ground truth in this context.
4. Adjudication method for the test set
This information is not applicable/not provided. Adjudication methods (like 2+1 or 3+1) are typically used in studies involving subjective interpretation (e.g., medical imaging) where human experts determine a "ground truth" or categorize findings. For a quantitative diagnostic like Cystatin C measurement, the ground truth is established analytically (e.g., precise reference methods, dry mass determination).
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 is not applicable. The device is an in vitro diagnostic assay kit for measuring Cystatin C concentration, not an AI-assisted diagnostic tool that involves human readers or interpretation of complex, multi-case scenarios.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this is a standalone device (algorithm only). The "algorithm" here refers to the immunoassay method itself and the T60 analyzer's processing of samples to yield a quantitative result. There is no human-in-the-loop performance component in the direct measurement process; the device outputs a quantitative value.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the Cystatin C calibrator and potentially other samples is established by traceability to a pure recombinant Cystatin C preparation, with its concentration determined by dry mass determination. This is a highly precise analytical method, serving as the "true" concentration for calibration and validation.
8. The sample size for the training set
This information is not provided. The document describes a traditional immunoassay, not a machine learning model, so the concept of a "training set" for an algorithm in the AI sense is not directly applicable. However, analytical studies for establishing assay parameters (e.g., linearity, sensitivity, specificity) would involve a range of samples and controls, but these are not explicitly termed a "training set" here.
9. How the ground truth for the training set was established
As noted above, a "training set" in the AI sense is not directly applicable. However, the ground truth for calibrators and control materials used in developing and validating the assay would be established through traceability to pure recombinant Cystatin C preparation with concentration determined by dry mass determination, as mentioned for the overall assay's standardization.
Ask a specific question about this device
Page 1 of 1