(80 days)
Stratus® CS Acute Care™ CardioPhase® hsCRP TestPak: The Stratus® CS Acute Care™ CardioPhase® hsCRP assay is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in lithium and sodium heparin plasma. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, is observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. High sensitivity CRP (hsCRP) measurements may be used as an independent risk marker for the identification of individuals at risk for future cardiovascular disease. Measurements of hsCRP, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.
Stratus® CS Acute Care™ CardioPhase® hsCRP CalPak: The Stratus® CS Acute Care™ CardioPhase® high sensitivity CRP Calibrator, is an in vitro diagnostic product intended to be used for calibration of the Acute Care™ CardioPhase® method on the Stratus® CS analyzer.
Stratus® CS Acute Care™ CardioPhase® hsCRP DilPak: The Stratus® CS Acute Care™ CardioPhase® high sensitivity CRP Dilution Pak, is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ CardioPhase® TestPak, for the measurement of samples with elevated levels of C-reactive protein.
The Stratus® CS Acute Care™ CardioPhase® hsCRP method is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Stratus® CS Acute™ Care CardioPhase® hsCRP device:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Metric | Predicate Device (Dade Behring CardioPhase® hsCRP on BN™ System) | Test Device (Stratus® CS Acute™ Care CardioPhase® hsCRP) Performance |
|---|---|---|---|
| Method Comparison (Regression Analysis) | Slope (0-50 mg/L) | N/A (Standard for comparison) | 0.952 |
| Intercept (0-50 mg/L) | N/A (Standard for comparison) | 0.098 | |
| Correlation Coefficient (0-50 mg/L) | N/A (Standard for comparison) | 0.999 | |
| Slope (0-10 mg/L) | N/A (Standard for comparison) | 0.997 | |
| Intercept (0-10 mg/L) | N/A (Standard for comparison) | 0.047 | |
| Correlation Coefficient (0-10 mg/L) | N/A (Standard for comparison) | 0.995 | |
| Slope (0-5 mg/L) | N/A (Standard for comparison) | 1.002 | |
| Intercept (0-5 mg/L) | N/A (Standard for comparison) | 0.042 | |
| Correlation Coefficient (0-5 mg/L) | N/A (Standard for comparison) | 0.994 |
Study Details:
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Sample size used for the test set and the data provenance:
- Sample Size: 154 plasma samples.
- Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective nature. However, it is a method comparison study using patient samples, which are typically retrospective or collected prospectively for validation purposes. Given the nature of a 510(k) submission for substantial equivalence to a legally marketed device, these are likely clinical samples run on both systems.
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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 summary. For this type of in vitro diagnostic device (quantitative assay), the "ground truth" is typically the measurement obtained from the predicate device itself, or a validated reference method against which both the predicate and new device are compared. Expert consensus in the traditional sense (e.g., radiologist review) is not applicable here.
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Adjudication method for the test set:
- This information is not applicable for this type of quantitative assay comparison. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., image readings) where disagreement between multiple readers needs to be resolved. In this case, the comparison is quantitative, comparing numerical results from two different assay systems.
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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:
- No, an MRMC comparative effectiveness study was not done. This is an in vitro diagnostic device (an assay for C-reactive protein) and does not involve human readers interpreting AI outputs. The "device" itself is an analytical instrument and reagents.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit. The study evaluates the performance of the "algorithm" (the Stratus® CS Acute™ Care CardioPhase® hsCRP assay) by comparing its quantitative results to a predicate device. This is a standalone evaluation of the analytical performance of the automated assay system, without human interpretation as part of the core measurement.
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The type of ground truth used:
- The "ground truth" for this study is the measurement obtained from the legally marketed predicate device, the Dade Behring CardioPhase® hsCRP assay, performed on the BN™ System. The study aims to demonstrate that the new device produces results substantially equivalent to an already accepted method.
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The sample size for the training set:
- This information is not provided in the summary. For a non-AI based assay like this, there isn't typically a "training set" in the machine learning sense. Assay development involves optimizing reagents and protocols, and validation studies (like the one reported) are performed once development is complete.
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How the ground truth for the training set was established:
- This information is not applicable as there is no mention of a "training set" in the context of an AI/machine learning algorithm. For traditional IVDs, assay development and internal validation would precede the formal comparison study.
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).