(55 days)
Sigma Diagnostics CX 3 Calibration Standard Level 1 is used to calibrate the Beckman SYNCHRON CX 3 System. This reagent is used for the quantitative determination of BUN/urea, calcium, and total carbon dioxide in serum or plasma; of creatinine, potassium, and sodium in serum, plasma, or urine; and of chloride and glucose in serum, plasma, urine, or cerebrospinal fluid. Calibration Standard Level 1 should be used with CX 3 Calibration Standard Level 2.
CX 3 Calibration Standard Level 1 contains the following analytes and other non-reactive components:
| ANALYTE | CONVENTIONAL UNITS | SI UNITS |
|---|---|---|
| Calcium | 10.0 mg/dL | 2.495 mmol/L |
| Chloride | 109 mmol/L | 109 mmol/L |
| Creatinine | 5.0 mg/dL | 442 umol/L |
| Glucose | 150 mg/dL | 8.34 mmol/L |
| Potassium | 4.0 mmol/L | 4.0 mmol/L |
| Sodium | 150 mmol/L | 150 mmol/L |
| Urea | 107 mg/dL | 17.8 mmol/L |
| BUN (Urea | ||
| Nitrogen) | 50 mg/dL | 17.8 mmol/L |
This 510(k) submission describes a calibration standard, not a medical device that performs diagnostic or screening tasks using an algorithm or AI. Therefore, most of the requested information regarding acceptance criteria, study design, expert ground truth, and AI performance metrics is not applicable to this type of product.
However, I can extract the relevant information regarding the "acceptance criteria" (which in this context refers to the intended values and the "study" demonstrating equivalence).
Here's a breakdown of the available information in the format requested, with clarifications for non-applicability:
1. A table of acceptance criteria and the reported device performance
For a calibration standard, the "acceptance criteria" are the target analyte concentrations it is designed to deliver. The "device performance" in this context refers to its intended use and its substantial equivalence to an existing product.
| Analyte | Acceptance Criteria (Target Value) - Conventional Units | Acceptance Criteria (Target Value) - SI Units | Reported Device Performance (Reference Standard Equivalence) |
|---|---|---|---|
| Calcium | 10.0 mg/dL | 2.495 mmol/L | Substantially equivalent to Beckman Calibration Standard 1 |
| Chloride | 109 mmol/L | 109 mmol/L | Substantially equivalent to Beckman Calibration Standard 1 |
| Creatinine | 5.0 mg/dL | 442 umol/L | Substantially equivalent to Beckman Calibration Standard 1 |
| Glucose | 150 mg/dL | 8.34 mmol/L | Substantially equivalent to Beckman Calibration Standard 1 |
| Potassium | 4.0 mmol/L | 4.0 mmol/L | Substantially equivalent to Beckman Calibration Standard 1 |
| Sodium | 150 mmol/L | 150 mmol/L | Substantially equivalent to Beckman Calibration Standard 1 |
| Urea | 107 mg/dL | 17.8 mmol/L | Substantially equivalent to Beckman Calibration Standard 1 |
| BUN (Urea Nitrogen) | 50 mg/dL | 17.8 mmol/L | Substantially equivalent to Beckman Calibration Standard 1 |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable in the context of an algorithm's test set. This product is a physical reagent. The "study" here is a demonstration of substantial equivalence, which would involve chemical analysis to confirm the concentrations and stability of the standard. The specific sample sizes and testing protocols for demonstrating equivalence are not detailed in this summary document but would be part of the full 510(k) submission.
- Data provenance: Not applicable. This is not a study involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "ground truth" for a test set in the sense of expert annotation for a calibration standard. The "ground truth" for a calibration standard is its precisely manufactured chemical composition, verified through analytical chemistry methods.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This refers to a process of resolving discrepancies in expert opinions on medical images or diagnoses, which is irrelevant for a calibration standard.
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 product is a calibration standard, not a diagnostic AI device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This product does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Chemical Composition. The "ground truth" for a calibration standard is its precisely controlled and measured chemical composition. It is manufactured to contain specific concentrations of analytes, which are then verified through analytical chemistry techniques, often traceable to reference materials.
8. The sample size for the training set
- Not applicable. This product does not involve a training set for an algorithm.
9. How the ground truth for the training set was established
- Not applicable. This product does not involve a training set for an algorithm.
Summary of the "Study" for this Calibration Standard:
The "study" referenced in this 510(k) summary is the demonstration of substantial equivalence to an existing legally marketed device, Beckman Calibration Standard 1 (Part No. 443360). This typically involves:
- Analytical Chemistry: Verifying that the Sigma Diagnostics CX 3 Calibration Standard, Level 1, contains the specified concentrations of analytes within acceptable limits.
- Performance Testing: Demonstrating that when used with the Beckman SYNCHRON CX 3 System, it functions equivalently to the predicate device for calibrating the quantitative determination of the listed analytes. This would likely involve testing on actual patient samples or control materials after calibration with both the new and predicate standards to show comparable results.
- Stability Studies: Ensuring the standard maintains its intended concentration over its declared shelf life.
The document states that the "safety and effectiveness... are demonstrated by its substantial equivalency to Beckman Calibration Standard 1, Part No. 443360." This is the core "study" and acceptance criterion for this type of submission.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.