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510(k) Data Aggregation
(35 days)
REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE
The Revised C-Reactive Protein (RCRP) Flex™ reagent cartridge for the Dimension® clinical chemistry system is an in vitro diagnostic device intended to quantitatively measure Creactive protein in human serum and plasma. Measurements of C-reactive protein are used in the evaluation of the amount of injury to body tissues.
The RCRP method is based on a particle enhanced turbidmetric immunoassay (PETIA) technique. Latex particles coated with antibody to C-Reactive Protein aggregate in the presence of C-Reactive Protein in the sample. The increase in turbidity which accompanies aggregation is proportional to the C-Reactive Protein concentration. The concentration is determined by means of a mathematical function.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Quantitative equivalence to predicate device (N Latex CRP mono assay): | Correlation coefficient: 0.998 |
| - High correlation coefficient (R-value close to 1) | Slope: 0.95 |
| - Slope close to 1 | Intercept: -0.13 mg/L [-1.3 mg/L] |
| Qualitative equivalence to predicate device (N Latex CRP mono assay): | |
| - Ability to measure C-Reactive Protein in human serum and plasma. | Same sample types (serum and plasma) as the predicate device. |
| - Intended Use aligned with the predicate device (implied, as substantial equivalence is claimed based on this comparison study). | Intended Use: "quantitatively measure C-Reactive Protein in human serum and plasma." This aligns with the C-Reactive Protein Test System classification, implying similar intended use to the predicate. |
| - Robustness of measurement through a recognized immunoassay technique. | Utilizes a "particle enhanced turbidimetric immunoassay (PETIA) technique," which is a recognized method for such measurements, though different from the predicate's "particle agglutination immunonephelometry." The performance demonstrates this technique is equivalent for the stated purpose. |
| Safety and Effectiveness: (General regulatory requirement, not specific numerical criteria given for this device in the document snippet) | The FDA's 510(k) clearance explicitly states: "We have determined the device is substantially equivalent... You may, therefore, market the device, subject to the general controls provisions of the Act." This implies the device meets the general requirements for safety and effectiveness for its intended use through substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 221 clinical patient samples.
- Data Provenance: Retrospective, as indicated by "clinical patient samples." The country of origin is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- The document does not provide information regarding experts establishing ground truth for the test set. The study compares the performance of the new device against a legally marketed predicate device (N Latex CRP mono assay), assuming the predicate device's measurements constitute the "ground truth" or reference for establishing equivalence.
4. Adjudication Method for the Test Set
- No adjudication method is described. The study is a direct comparison between two measurement devices rather than an interpretation of results by multiple human readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
- No MRMC comparative effectiveness study was done. This study focuses on device performance equivalence, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, a standalone study was done. The RCRP Flex™ reagent cartridge is a fully automated in-vitro diagnostic device. The performance data (correlation, slope, intercept) demonstrate its standalone analytical performance compared to the predicate device, without human intervention in the measurement process itself.
7. Type of Ground Truth Used
- The "ground truth" for this study was established using the measurements from the predicate device, the N Latex CRP mono assay (K962523). The study aims to show that the new device's measurements are substantially equivalent to those of a previously cleared device.
8. Sample Size for the Training Set
- The document does not specify a training set sample size. This type of immunoassay device (particle enhanced turbidimetric immunoassay) typically relies on chemical and biological principles for its operation and calibration curves, rather than machine learning models that require distinct training sets. Calibration would be performed during manufacturing and potentially by users, but the "training set" concept as used in AI/ML is not applicable here.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there's no mention of a traditional "training set" in the context of an AI/ML algorithm. The calibration of the device (if applicable) would typically be established using reference materials with known concentrations of C-Reactive Protein, but this is not detailed in the provided summary.
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