(37 days)
C3 reagent, when used in conjunction with SYNCHRON LX® Systems and Calibrator 1, is intended for quantitative determination of Complement C3 concentration in human serum or plasma by rate turbidimetry.
C4 reagent, when used in conjunction with SYNCHRON LX® Systems and Calibrator 1, is intended for quantitative determination of Complement C4 concentration in human serum or plasma by turbidimetry.
The Beckman Coulter SYNCHRON LX® Systems Calibrator 1 (CAL 1), used in conjunction with SYNCHRON LX reagents, is intended for the calibration of the immunoprotein tests on SYNCHRON LX Systems.
The SYNCHRON LX® C3 and C4 Reagents are designed for optimal performance on the SYNCHRON LX® Systems. The reagent kit contains two 100-test cartridges that are packaged separately from the associated calibrators. The LX CAL 1 kit contains four 3 mL - bottles.
This is a 510(k) premarket notification for in vitro diagnostic devices. These submissions typically do not contain detailed acceptance criteria and study designs in the same way that studies for AI/ML-based medical devices or devices undergoing clinical trials might. Instead, they focus on demonstrating substantial equivalence to a predicate device through performance data.
Based on the provided text, here's an analysis of the "acceptance criteria" and "study" information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a set of predefined thresholds that the device must meet. Instead, it presents performance data (method comparison, imprecision, and anticoagulant studies) to demonstrate the device's characteristics and its equivalence to the predicate.
Here's an attempt to structure the provided performance data, inferring the underlying objectives:
| Performance Metric | Inferred Acceptance Criteria (Implicit) | Reported Device Performance (SYNCHRON LX) |
|---|---|---|
| Method Comparison (C3) | Slope approximately 1.0, Intercept approximately 0, r (correlation) close to 1.0, Confidence Intervals indicating precision around these values, demonstrating equivalence to IMMAGE C3 Reagent. | Slope: 1.025 (Confidence: 0.023) |
| Intercept: 2.307 (Confidence: 2.783) | ||
| r: 0.992 | ||
| n: 134 samples (compared to IMMAGE C3 Reagent) | ||
| Method Comparison (C4) | Slope approximately 1.0, Intercept approximately 0, r (correlation) close to 1.0, Confidence Intervals indicating precision around these values, demonstrating equivalence to IMMAGE C4 Reagent. | Slope: 1.001 (Confidence: 0.027) |
| Intercept: 0.938 (Confidence: 0.717) | ||
| r: 0.985 | ||
| n: 160 samples (compared to IMMAGE C4 Reagent) | ||
| C3 Imprecision (Within-Run) | Low % C.V. (Coefficient of Variation) indicating good repeatability. | Serum Control 1: Mean 55.6 mg/dL, SD 0.97, % C.V. 1.75 |
| Serum Control 2: Mean 170.8 mg/dL, SD 2.20, % C.V. 1.29 | ||
| Serum Control 3: Mean 237.4 mg/dL, SD 2.27, % C.V. 0.96 | ||
| Serum Pool 1: Mean 28.9 mg/dL, SD 0.49, % C.V. 1.71 | ||
| C3 Imprecision (Total) | Low % C.V. indicating good reproducibility. | Serum Control 1: Mean 55.6 mg/dL, SD 1.21, % C.V. 2.19 |
| Serum Control 2: Mean 170.8 mg/dL, SD 2.44, % C.V. 1.43 | ||
| Serum Control 3: Mean 237.4 mg/dL, SD 2.92, % C.V. 1.23 | ||
| Serum Pool 1: Mean 28.9 mg/dL, SD 0.57, % C.V. 1.98 | ||
| C4 Imprecision (Within-Run) | Low % C.V. indicating good repeatability. | Serum Control 1: Mean 25.1 mg/dL, SD 0.40, % C.V. 1.59 |
| Serum Control 2: Mean 38.0 mg/dL, SD 0.50, % C.V. 1.32 | ||
| Serum Control 3: Mean 50.1 mg/dL, SD 0.85, % C.V. 1.70 | ||
| Serum Pool 1: Mean 9.5 mg/dL, SD 0.23, % C.V. 2.37 | ||
| Serum Pool 2: Mean 70.3 mg/dL, SD 1.07, % C.V. 1.53 | ||
| C4 Imprecision (Total) | Low % C.V. indicating good reproducibility. | Serum Control 1: Mean 25.1 mg/dL, SD 0.46, % C.V. 1.82 |
| Serum Control 2: Mean 38.0 mg/dL, SD 0.64, % C.V. 1.68 | ||
| Serum Control 3: Mean 50.1 mg/dL, SD 1.09, % C.V. 2.17 | ||
| Serum Pool 1: Mean 9.5 mg/dL, SD 0.29, % C.V. 3.09 | ||
| Serum Pool 2: Mean 70.3 mg/dL, SD 1.34, % C.V. 1.91 | ||
| C3 Anticoagulant Study | Y ≈ X, r close to 1.0, demonstrating minimal interference from specified anticoagulants. | Lithium Heparin: Y = 0.966X + 0.28; r = 0.985 |
| Sodium Heparin: Y = 0.979X - 0.95; r = 0.979 | ||
| EDTA: Y = 0.855X + 5.27; r = 0.988 | ||
| C4 Anticoagulant Study | Y ≈ X, r close to 1.0, demonstrating minimal interference from specified anticoagulants. | Lithium Heparin: Y = 0.899X + 1.21; r = 0.978 |
| Sodium Heparin: Y = 0.900X + 0.76; r = 0.992 | ||
| EDTA: Y = 0.967X + 0.34; r = 0.985 |
2. Sample Size for the Test Set and Data Provenance:
- Method Comparison:
- C3 Reagent: n = 134 samples
- C4 Reagent: n = 160 samples
- Imprecision Studies:
- For each sample type (Serum Controls, Serum Pools) in both C3 and C4, N = 80 measurements were performed (this seems to combine within-run and total imprecision measurements, implying 80 distinct runs/samples for each data point).
- Anticoagulant Studies: The number of samples for each anticoagulant type is not explicitly stated, but Deming Regression Analysis was performed.
- Data Provenance: Not explicitly mentioned (e.g., country of origin). The studies appear to be prospective in nature, as they involve testing the new device against a predicate or evaluating its performance characteristics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
This type of information is not applicable to this submission. This device is an in vitro diagnostic (IVD) reagent for quantitative measurement of C3 and C4 proteins in human serum or plasma. The "ground truth" here is the actual concentration of these proteins, as measured by a established, legally marketed predicate device (Beckman IMMAGE C3 and C4 Reagents) or by control materials with known values. There are no human "experts" establishing a subjective "ground truth" for the test set of an IVD.
4. Adjudication Method for the Test Set:
Not applicable. As the "ground truth" is based on quantitative measurements by a predicate device or control materials, there is no need for human 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 submission is for an IVD reagent and calibrator, not an AI/ML-based diagnostic imaging or detection system that involves human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a standalone diagnostic test in the sense that its performance is evaluated directly through its ability to accurately measure analyte concentrations. It doesn't involve a human-in-the-loop for interpretation beyond standard laboratory procedures for running the assay and reviewing results. It's essentially an "algorithm only" in that the chemical reactions and optical detection on the SYNCHRON LX System constitute its operational mechanism.
7. The type of ground truth used:
The ground truth for the performance studies is established by:
- Predicate Method: For method comparison studies, the results obtained from the new SYNCHRON LX C3/C4 Reagents are compared to those obtained from the legally marketed Beckman IMMAGE C3/C4 Reagents. The IMMAGE system (nephelometry) serves as the reference method.
- Known Control Values: For imprecision studies, commercial Serum Control materials with established target values are used, along with Serum Pools. These controls inherently have known or very well-characterized concentrations, which act as the ground truth for evaluating variability.
8. The sample size for the training set:
Not applicable. This submission is for a traditional IVD reagent, not an AI/ML device that requires a training set. The "development" of the reagent relies on chemical formulation and optimization, not machine learning from a data set.
9. How the ground truth for the training set was established:
Not applicable. (See point 8).
§ 866.5240 Complement components immunological test system.
(a)
Identification. A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.(b)
Classification. Class II (performance standards).