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510(k) Data Aggregation
(333 days)
RCRP Flex reagent cartridge
The C-Reactive Protein Extended Range (RCRP) method used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of CRP in human serum and plasma (lithium heparin). Measurement of C-Reactive Protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.
The RCRP method is based on a particle enhanced turbidimetric immunoassay (PETIA) technique. Synthetic particles coated with antibody to C-Reactive Protein (AbPR) 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.
This document describes the RCRP Flex® reagent cartridge, an in vitro diagnostic test for the quantitative determination of C-Reactive Protein (CRP) in human serum and plasma. The submission is a special 510(k) for a modified device, primarily due to an update in traceability from IFCC CRM 470 to ERM-DA474/IFCC reference material and a change in the analytical measurement range (AMR).
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and observed performance are provided for the method comparison studies.
| Attribute | Acceptance Criteria | Reported Device Performance (Modified RCRP vs. Predicate RCRP) | Pass/Fail | Reported Device Performance (RCRP Dimension RXL vs. N High Sensitivity CRP) | Pass/Fail |
|---|---|---|---|---|---|
| Slope | $1.00 \pm 0.1$ | 0.99 | Pass | 0.95 | Pass |
| y-intercept | $0.0 \pm 2.0$ mg/L | -0.5 mg/L | Pass | -1.6 mg/L | Pass |
| Correlation Coefficient (r) | $\geq 0.9600$ | 1.000 | Pass | 0.997 | Pass |
Detection Capability (LoB, LoD, LoQ)
| Specimen Type | Detection Capability | Acceptance Criteria | Result (mg/L / mg/dL) |
|---|---|---|---|
| Serum and Lithium Heparin Plasma | LoB | ≤ LoD | 0.6 mg/L (0.06 mg/dL) |
| LoD | ≤ LoQ | 1.0 mg/L (0.10 mg/dL) | |
| LoQ | ≤ 5.0 mg/L | 5.0 mg/L (0.50 mg/dL) |
Interference
| Endogenous Substance Tested | Endogenous Substance Concentration | Analyte Concentration | Acceptance Criteria (Bias) | Bias (%) |
|---|---|---|---|---|
| Hemoglobin (hemolysate) | [500 mg/dL] 5.0 g/L | [11.6 mg/L] 1.16 mg/dL | Bias exceeding 10% is interference | 0% |
| Bilirubin (Unconjugated) | [40 mg/dL] 684 µmol/L | [11.7 mg/L] 1.17 mg/dL | Bias exceeding 10% is interference | 2% |
| Lipemia (Intralipid) | [250 mg/dL] 2.5 g/L | [11.8 mg/L] 1.18 mg/dL | Bias exceeding 10% is interference | -9% |
| Lipemia (Triglyceride Fraction) | [750 mg/dL] 7.5 g/L | [11.1 mg/L] 1.11 mg/dL | Bias exceeding 10% is interference | -7% |
2. Sample Sample Size Used for the Test Set and Data Provenance
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Method Comparison – Modified RCRP assay vs Predicate RCRP assay:
- Sample Size: 132 individual human native serum samples.
- Data Provenance: Samples were obtained from "specimen vendors". The country of origin is not specified, nor is whether the data is retrospective or prospective.
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Method Comparison - RCRP assay on Dimension RXL system vs N High Sensitivity CRP on the BN™ System:
- Sample Size: 171 for the overall comparison (5.3 to 241.3 mg/L) and 39 for the narrower range (5.3 to 20.2 mg/L).
- Data Provenance: This study involved "re-analyzed historical IFU data." The original provenance (country, retrospective/prospective) of this historical data is not specified.
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Linearity Testing: Not specified, but generally involves a set of diluted samples or spiked matrix covering the analytical measurement range.
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Detection Capability (LoB, LoD, LoQ): Not specified.
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Precision:
- Sample Size: 6 serum samples, analyzed with N=10 replicates each day for 5 days (total of 50 replicates per sample level).
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Specimen Equivalency:
- Sample Size: 73 samples.
- Data Provenance: Not specified, but likely from specimen vendors similar to the method comparison.
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Interference:
- Sample Size: Not explicitly stated, but typically involves a control sample and test samples (with interferent) for assessment of bias.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes an in vitro diagnostic (IVD) test, specifically an immunoassay for C-Reactive Protein. The "ground truth" for such devices is typically established through a reference method or known concentrations of certified reference materials, not through expert consensus or interpretation in the same way an imaging AI might.
- No human experts (e.g., radiologists) were used to establish ground truth for this type of device. The assessment is based on measured concentrations against established reference standards.
4. Adjudication Method for the Test Set
Not applicable. As described above, the ground truth for an IVD device like this is based on quantitative measurements and reference materials, not subjective interpretations requiring adjudication.
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
Not applicable. This is an in vitro diagnostic assay, not an AI-powered image analysis or diagnostic assist device that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This device is a standalone algorithm/reagent system designed for automated quantitative measurement on a clinical chemistry system. Its performance is evaluated intrinsically through various analytical studies (method comparison, linearity, precision, detection capability, interference) without human-in-the-loop performance influencing the measurement itself. The results are then interpreted by clinicians.
7. The Type of Ground Truth Used
The ground truth for this device is based on:
- Reference Materials: For standardization, the device is traceable to ERM-DA474/IFCC reference material (and previously IFCC CRM 470). These are internationally recognized certified reference materials for CRP.
- Comparative Methods: The performance is benchmarked against a predicate RCRP assay and the N High Sensitivity CRP on the BN™ System. These are established laboratory methods.
- Clinical Laboratory Standards (CLSI): The studies follow guidelines from CLSI, which define how to robustly evaluate analytical performance parameters like precision, linearity, and detection limits.
8. The Sample Size for the Training Set
This document does not describe a machine learning or AI model that requires a distinct "training set" in the conventional sense. The device is a chemical reagent and assay system. Its "training" or development would involve extensive experimentation and optimization during the R&D phase to ensure reagent stability, reaction kinetics, and signal transduction are robust and accurate. This is not typically quantified as a "training set size" like in AI/ML contexts.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/ML device with a defined training set and ground truth in that context. The "ground truth" for the development of such an assay would be through rigorous chemical and biological characterization, using known concentrations of analytes, reference materials, and established analytical chemistry principles.
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(104 days)
RCRP FLEX REAGENT CARTRIDGE
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(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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