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510(k) Data Aggregation
(73 days)
High Sensitivity Cardiac C-Reactive Protein (CCRP) reagent, when used in conjunction with IMMAGE® 800 Immunochemistry Systems and Calibrator 5 Plus, is intended for the quantitative determination of C-Reactive protein in human serum or plasma by rate turbidimetry.
Measurement of C-Reactive protein (CRP) aids in evaluation of stress, trauma, infection, inflammation, surgery, and associated diseases. Cardiac CRP assays are indicated for use as an aid in the identification and stratification of individuals at risk for future cardiovascular disease. When used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, CRP may be useful as an independent marker of prognosis for recurrent events in patients with stable coronary disease or acute coronary syndrome.
CAL 5 Plus (Calibrator 5 Plus), when used in conjunction with Beckman Coulter reagents, is intended for use on IMMAGE® Immunochemistry Systems for the calibration of Anti-Streptolysin O (ASO), C-Reactive Protein (CRP) and Rheumatoid Factor (RF).
High Sensitivity Cardiac C-Reactive Protein (CCRP) reagent is intended for the quantitative determination of C-Reactive protein in human serum or plasma by rate turbidimetry. The IMMAGE® 800 Immunochemistry Systems CCRP reagent is based on the highly sensitive Near Infrared Particle Immunoassay rate methodology. An anti-CRP antibody-coated particle binds to CRP in the patient sample resulting in the formation of insoluble aggregates causing turbidity. The rate of aggregate formation is directly proportional to the concentration of CRP in the sample.
CAL 5 Plus (Calibrator 5 Plus) is a frozen liquid serum matrix intended for use on IMMAGE® Immunochemistry Systems for the calibration of Anti-Streptolysin O (ASO), C-Reactive Protein (CRP) and Rheumatoid Factor (RF).
Here's a breakdown of the acceptance criteria and study information for the Immage® 800 Immunochemistry Systems High Sensitivity Cardiac C-Reactive Protein (CCRP) Reagent, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative format for method comparison, linearity, or imprecision (e.g., "slope must be between X and Y"). However, it presents the results of these studies, and the FDA's decision to grant substantial equivalence implies that these results met their internal criteria for acceptance.
For the purpose of this analysis, I will infer the implicit acceptance criteria from the context of standard analytical performance requirements for diagnostic devices and the successful outcome of the 510(k) submission.
| Performance Characteristic | Acceptance Criteria (Inferred) | Reported Device Performance (Immage® High Sensitivity Cardiac CCRP Reagent) |
|---|---|---|
| Method Comparison | ||
| Slope (vs. Predicate) | Close to 1.0 | 0.965 (0.2 to 60 mg/L) |
| 1.013 (0.2 to 10 mg/L) | ||
| Intercept (vs. Predicate) | Close to 0 | 0.334 (0.2 to 60 mg/L) |
| -0.026 (0.2 to 10 mg/L) | ||
| R (Correlation Coefficient) | Close to 1.0 | 0.9962 (0.2 to 60 mg/L) |
| 0.9939 (0.2 to 10 mg/L) | ||
| Imprecision (Within-Run) | %CV typically < 5-10% | Level 1: 2.8% (Mean 0.807 mg/dL) |
| Level 2: 3.0% (Mean 13.56 mg/dL) | ||
| Level 3: 3.3% (Mean 51.538 mg/dL) | ||
| Imprecision (Total) | %CV typically < 5-10% | Level 1: 3.5% (Mean 0.807 mg/dL) |
| Level 2: 3.1% (Mean 13.56 mg/dL) | ||
| Level 3: 4.3% (Mean 51.538 mg/dL) | ||
| Stability (Calibrator) | At least 24 months | Predicted 32-33 months (based on accelerated studies) |
| Linearity | Device should demonstrate linearity across its stated analytical range (0.2 to 60.0 mg/L, extended to 1440.0 mg/L). | No specific data presented in the summary, but implied to be acceptable for 510(k) submission. Documentation notes "linearity experiments" were performed. |
Note: The "acceptance criteria" are inferred based on typical industry standards for analytical performance. The document itself states that "The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence... Equivalence is demonstrated through method comparison, stability, linearity, and imprecision experiments." This indicates the reported performance met the internal criteria for FDA clearance.
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison Test Set:
- N: 157 samples (for range 0.2 to 60 mg/L) and 98 samples (for range 0.2 to 10 mg/L).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, given it's a clinical diagnostic test, samples would typically be from human serum or plasma. It's common for such studies to use a combination of prospective patient samples and spiked samples to cover the analytical range. The document refers to "the patient sample," suggesting clinical samples were used.
- Imprecision Test Set:
- N: 80 replicates per level (three levels tested).
- Data Provenance: Not explicitly stated. These would typically be internal quality control materials or pooled patient samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This device is a diagnostic reagent for quantitative measurement of a biomarker (CRP). The "ground truth" for quantitative assays is established by reference methods or established predicate devices, not by expert consensus in the way image-based or clinical diagnostic (e.g., physician-interpreted) devices use experts.
- The "ground truth" for the method comparison study was the results obtained from the Dade Behring CardioPhase hsCRP predicate device.
4. Adjudication Method for the Test Set
- Not Applicable. As described above, this is a quantitative measurement device, not one requiring human interpretation and subsequent adjudication of discrepancies. The comparison is statistical against a predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is not relevant for this type of in vitro diagnostic device (reagent for quantitative measurement). MRMC studies are used for devices that involve human interpretation of images or other data, often to assess the impact of AI assistance on diagnostic accuracy.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes. This is a standalone performance study. The Immage® High Sensitivity Cardiac CCRP Reagent, when used with the IMMAGE® 800 Immunochemistry Systems, directly provides a quantitative result. There is no human interpretation of raw data or "human-in-the-loop" decision-making that modifies the final reported CRP concentration from the device. The reported values are the output of the algorithm/reagent system itself.
7. Type of Ground Truth Used
- Predicate Device Results (Comparative Ground Truth): For the method comparison, the "ground truth" was effectively the results obtained from the legally marketed Dade Behring CardioPhase hsCRP predicate device. The goal was to show substantial equivalence, meaning the new device's results correlate highly and agree well with the predicate.
- Quantitative Analytical Targets: For imprecision and linearity studies, the "ground truth" would be established concentrations in quality control materials or spiked samples.
8. Sample Size for the Training Set
- Not explicitly stated in the summary. This document is a 510(k) summary, which focuses on validation data rather than detailed development or training data. For a reagent (chemical/immunological assay), the "training set" doesn't typically refer to a data set for machine learning in the same way it would for an AI algorithm. Instead, it would refer to the samples and experiments used during the assay development and optimization phase to establish reagents, reaction conditions, and calibration curve parameters. This detailed development data is not usually included in a 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
- Not explicitly stated in the summary. Similar to point 8, the "ground truth" for developing and optimizing an analytical reagent would involve:
- Known concentrations: Using reference materials or gravimetrically prepared standards with known CRP concentrations.
- Comparison to existing methods: Benchmarking against established reference methods or predicate devices during development to refine the assay's performance and ensure it meets desired analytical characteristics (sensitivity, specificity, dynamic range).
This process is part of the extensive R&D phase that precedes the formal validation studies presented in the 510(k) submission.
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