(43 days)
The Calcium assay is used for the quantitation of calcium in human serum, plasma, or urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany (intermittent muscular contractions or spasms).
Calcium is an in vitro diagnostic assay for the quantitative determination of calcium in human serum, plasma, or urine. The Calcium assay is a clinical chemistry assay in which arsenazo-III dye reacts with calcium in an acid solution to form a blue-purple complex. The color developed is measured at 600 nm and is proportional to the calcium concentration in the sample.
The provided text describes the 510(k) summary for the Abbott Laboratories Calcium assay, comparing its performance to the Boehringer Mannheim Calcium assay on the Hitachi 717 Analyzer.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by showing "acceptable correlation" and "substantially equivalent" performance to the predicate device. The performance metrics reported are correlation coefficient, slope, Y-intercept (for method comparison), and total %CV (for precision).
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (Serum) | Reported Device Performance (Urine) |
|---|---|---|---|
| Method Comparison | "Acceptable correlation" to predicate device | ||
| Correlation Coefficient | High (close to 1) | 0.9771 | 0.9987 |
| Slope | Close to 1.0 | 1.011 | 1.039 |
| Y-intercept | Close to 0 | 0.456 mg/dL | 0.048 mg/dL |
| Precision (Total %CV) | Low (indicating good reproducibility) | Level 1: 1.7%, Level 2: 1.1% | Level 1: 1.4%, Level 2: 1.0% |
| Linearity | Covered the expected clinical range | Up to 27.24 mg/dL | Up to 30.8 mg/dL |
| Limit of Quantitation | Sufficiently low for clinical sensitivity | 0.03 mg/dL | 0.03 mg/dL |
2. Sample Size and Data Provenance
- Sample Size: The document does not explicitly state the specific number of samples (e.g., patient samples) used in the method comparison or precision studies. It mentions "two levels of control material" for precision studies.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts and Qualifications
This information is not provided in the given text. This type of information is typically not included in a 510(k) summary for an in vitro diagnostic assay, as the "ground truth" for quantitative assays is based on established reference methods and laboratory measurements, not expert consensus on interpretations.
4. Adjudication Method
This information is not provided in the given text, and is not applicable to an in vitro diagnostic assay where ground truth is established by quantitative measurement against a reference method or predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices or other diagnostic tools where human interpretation is a key component, not for in vitro diagnostic assays.
6. Standalone Performance
The studies described are primarily standalone performance studies, demonstrating the algorithm's (assay's) performance characteristics (correlation, precision, linearity, sensitivity) against a predicate device and reference standards. The "assay" itself is the "algorithm" in this context. There is no human-in-the-loop component mentioned in these performance evaluations.
7. Type of Ground Truth Used
The ground truth for the test set was established by the predicate device (Boehringer Mannheim Calcium assay on the Hitachi 717 Analyzer) and reference standards for precision, linearity, and limit of quantitation. For quantitative assays like this, the "ground truth" is the accurately measured concentration of the analyte.
8. Sample Size for the Training Set
This information is not provided. For a traditional in vitro diagnostic chemical assay, the concept of a "training set" as understood in machine learning is not directly applicable. The assay itself is based on chemical reactions and optical measurements, not on a machine learning model trained on a dataset. Development and calibration might involve numerous samples, but it's not typically referred to as a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is generally not applicable to this type of device. The "ground truth" for developing and calibrating such an assay would be based on precise chemical standards and established methodologies to ensure accurate measurement of calcium concentrations.
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.