(31 days)
The SYNCHRON® Systems C-Reactive Protein (CRP) Reagent , in conjunction with the SYNCHRON CX® CRP Calibrator Set, is intended for the quantitative determination of C-reactive protein concentration in serum or plasma.
The SYNCHRON Systems C-Reactive Protein (CRP) Reagent is designed for optimal performance on Beckman's SYNCHRON® Systems. It is intended for use in the quantitative determination of human C-reactive protein by rate nephelometry.
The SYNCHRON® Systems C-Reactive Protein (CRP) Reagent is a device for the quantitative determination of C-reactive protein in serum or plasma. The device was submitted for 510(k) clearance and found substantially equivalent to the IMMAGE™ Immunochemistry System C-Reactive Protein (CRP) Reagent (K963061).
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state "acceptance criteria" for each performance metric, but it does present performance data that would have been evaluated against internal or regulatory thresholds for substantial equivalence. The "Reported Device Performance" column reflects the results provided.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Method Comparison (vs. IMMAGE System CRP Reagent) | The regression analysis of SYNCHRON CRP vs. IMMAGE CRP should demonstrate good correlation and agreement, ideally close to a regression line of Y = 1.0X + 0.0 with a high correlation coefficient (r). | Not explicitly stated, but the summary states "The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution." No specific regression equation or correlation coefficient is provided for the method comparison directly. |
| Serum vs. Plasma Correlation | Strong correlation (high 'r' value) and close agreement (slope near 1, intercept near 0) between serum and plasma samples with various anticoagulants. | Lithium Heparin: Y = 1.042X - 0.45; r = 0.977 |
| Sodium Heparin: Y = 0.994X - 0.07; r = 0.989 | ||
| EDTA: Y = 0.992X - 0.20; r = 0.967 | ||
| Within-Run Imprecision (Low Level) | Low Coefficient of Variation (%CV) | Level 1 (1.03 IU/mL): 4.46% CV |
| Within-Run Imprecision (Medium Level) | Low Coefficient of Variation (%CV) | Level 2 (4.06 IU/mL): 1.58% CV |
| Within-Run Imprecision (High Level) | Low Coefficient of Variation (%CV) | Level 3 (7.09 IU/mL): 1.14% CV |
| Total Imprecision (Low Level) | Low Coefficient of Variation (%CV) | Level 1 (1.03 IU/mL): 5.49% CV |
| Total Imprecision (Medium Level) | Low Coefficient of Variation (%CV) | Level 2 (4.06 IU/mL): 4.49% CV |
| Total Imprecision (High Level) | Low Coefficient of Variation (%CV) | Level 3 (7.09 IU/mL): 3.56% CV |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Method Comparison: The document states "145 SUSSAFE SERVACETRY SERVED SERIE CONFECT STARE", but this appears to be garbled text. The table header "Method Comparison for CRP Reagent" suggests a comparison was performed, but the specific number of samples for this comparison is not clearly legible.
- Sample Size for Serum vs Plasma Study: The regression data provided for serum vs. plasma does not explicitly state the number of samples used for each anticoagulant study.
- Sample Size for Imprecision Study:
- Within-Run Imprecision: 80 replicates (N=80) for each of the three levels tested.
- Total Imprecision: 80 replicates (N=80) for each of the three levels tested.
- Data Provenance: Not explicitly stated. Given that Beckman Instruments, Inc. is located in Brea, California, USA, and the submission is to the FDA, it is highly probable that the data was generated in the USA. The studies are prospective as they were conducted to support the 510(k) submission for the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This device is a quantitative clinical chemistry reagent. The "ground truth" for such devices is typically established through a reference method or a predicate device, rather than expert human interpretation in the same way an imaging device might use radiologists. For the method comparison, the predicate device (IMMAGE™ Immunochemistry System C-Reactive Protein (CRP) Reagent) served as the reference for comparison.
Therefore, the concept of "number of experts" and "qualifications of experts" for establishing ground truth in this context is not applicable. The "ground truth" is based on the analytical results of established laboratory methods.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (like 2+1 or 3+1) is typically relevant for studies where human readers or interpreters make subjective assessments, such as interpreting medical images or clinical observations. Since this is an in-vitro diagnostic device providing a quantitative measurement, and the ground truth is established by a reference method or predicate device performance, an adjudication method for the test set is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is primarily for devices that assist human interpretation (e.g., AI for radiology), where the effect of the AI on human reader performance is measured. The SYNCHRON Systems C-Reactive Protein (CRP) Reagent is an automated in-vitro diagnostic assay for direct quantitative measurement.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was done
Yes, the performance data presented (Method Comparison, Serum vs. Plasma Study, and Imprecision) represents the standalone performance of the SYNCHRON® Systems C-Reactive Protein (CRP) Reagent without human-in-the-loop assistance for interpretation. The device itself performs the measurement.
7. The Type of Ground Truth Used
The ground truth used for the performance studies is based on:
- Comparison to a Predicate Device: For method comparison, the results generated by the predicate IMMAGE™ Immunochemistry System C-Reactive Protein (CRP) Reagent would serve as the comparative ground truth.
- Analytical Measurement: For imprecision, the ground truth is the inherent analytical measurement of the C-reactive protein in the samples by the device itself.
- Reference Standards: While not explicitly mentioned, it is typical for such studies to use quality control materials and calibrators traceable to international reference standards to ensure accuracy.
8. The Sample Size for the Training Set
This submission describes an in-vitro diagnostic reagent, not a machine learning or AI algorithm in the modern sense that typically involves "training sets." Therefore, the concept of a "training set" does not apply to this device. The development of such a reagent involves chemical formulation, optimization, and characterization, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
As stated above, the concept of a "training set" does not apply here, so the establishment of ground truth for a training set is not applicable.
§ 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).