(37 days)
The concentration of calcium is determined by the balance between absorption in the intestine and excretion in the kidneys and by exchanges between plasma, extracellular fluid and tissues including bone. Diseases associated with hypercalcemia include primary hyperthyroidism and hypercalcemia of malignancy. Hypocalcemia is associated with hypoparathyroidism and pseudohypoparathyroidism, vitamin D deficiency, hereditary vitamin D dependency, rickets types I and II, and intestinal malabsorption.1 Many methods exist for determining calcium. The o-cresophthalein complexone method remains popular in the clinical laboratory because performing it is fast and easy. The arsenazoIII method is a relatively new single reagent method. It is rapidly gaining popularity because it is even easier to use and has virtually no magnesium interference even at levels as high as 20 mg/dL.2 Further modifications to the method, in conjunction with sample blanking on the SYNCHRON CX 3 System, have resulted in a rapid calcium test with increased specificity. Both calcium reagents are used to measure calcium concentrations in serum, plasma, or urine on the SYNCHRON CX 3 System, and the reaction principles for both are identical.
Not Found
This is a 510(k) summary for a reagent, not an AI-powered diagnostic device. Therefore, many of the requested fields related to AI/ML device evaluation, such as sample sizes for test and training sets, expert ground truth, adjudication methods, and MRMC studies, are not applicable.
Here's an analysis based on the provided text, focusing on the equivalence study performed for this reagent:
Acceptance Criteria and Device Performance:
The primary acceptance criteria for the Sigma Diagnostics CX®-3 Calcium Reagent are demonstrated by its substantial equivalency to the Beckman Calcium Reagent Kit. This equivalency is assessed through correlation and precision studies.
| Acceptance Criteria (Implied by Equivalence Study) | Reported Device Performance (Sigma Diagnostics CX®-3 Calcium Reagent) |
|---|---|
| Correlation with Predicate Device (Beckman Calcium Reagent Kit): | |
| - Serum samples: High correlation coefficient (ideally close to 1) | - Serum samples: 0.982 |
| - Serum samples: Regression equation indicative of close agreement (slope near 1, intercept near 0) | - Serum samples: y = 0.95x + 0.54 |
| - Urine samples: High correlation coefficient (ideally close to 1) | - Urine samples: 0.996 |
| - Urine samples: Regression equation indicative of close agreement (slope near 1, intercept near 0) | - Urine samples: y = 1.02x - 0.15 |
| Precision (Within-run and Total): | |
| - Serum samples: Low %CV (indicating high precision) | - Serum samples: < 2.4 %CV |
| - Urine samples: Low %CV (indicating high precision) | - Urine samples: < 1.5 %CV |
| Linearity: (Indicates range over which the assay reliably measures calcium concentrations) | - Linear to 15.5 mg/dL |
Study Details:
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a specific number of samples. The text mentions "serum samples" and "urine samples" in general terms for the comparison studies.
- Data Provenance: Not specified (e.g., country of origin). The study is retrospective in the sense that it compares results from existing clinical samples, but the exact nature of the sample collection isn't detailed.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a chemical reagent study, not an imaging or diagnostic AI study requiring expert review of results to establish ground truth. The "ground truth" is established by the accepted reference method (the predicate device) and the accuracy of the lab instruments.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for a chemical reagent equivalence study.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an MRMC study. It's a comparison of two chemical reagents.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a reagent for a lab instrument, not an algorithm.
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The type of ground truth used: The "ground truth" in this context is the results obtained from the predicate device (Beckman Calcium Reagent Kit). The study aims to show that the new reagent produces results that are statistically equivalent to the established predicate. The principles of both reagents are stated to be identical.
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The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established: Not applicable.
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510(k) NOTIFICATION
Sigma Diagnostics 545 South Ewing Avenue St. Louis, MO 63103
CX®-3 Calcium Reagent Procedure No. C7183 August 30, 1996
OCT 10 1996
ATTACHMENT 1
Summary of Safety and Effectiveness
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510(K) NOTIFICATION
Sigma Diagnostics 545 South Ewing Avenue St. Louis, MO 63103
CX®3 Calcium Reagent Procedure Number C7183 August 31, 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
The concentration of calcium is determined by the balance between absorption in the intestine and excretion in the kidneys and by exchanges between plasma, extracellular fluid and tissues including bone. Diseases associated with hypercalcemia include primary hyperthyroidism and hypercalcemia of malignancy. Hypocalcemia is associated with hypoparathyroidism and pseudohypoparathyroidism, vitamin D deficiency, hereditary vitamin D dependency, rickets types I and II, and intestinal malabsorption.1
Many methods exist for determining calcium. The o-cresophthalein complexone method remains popular in the clinical laboratory because performing it is fast and easy.
The arsenazoIII method is a relatively new single reagent method. It is rapidly gaining popularity because it is even easier to use and has virtually no magnesium interference even at levels as high as 20 mg/dL.2 Further modifications to the method, in conjunction with sample blanking on the SYNCHRON CX 3 System, have resulted in a rapid calcium test with increased specificity.
The safety and effectiveness of Sigma Diagnostics Calcium Reagent, Procedure Number C7183, are demonstrated by its substantial equivalency to Beckman Calcium Reagent Kit, Part No. 450890. Both calcium reagents are used to measure calcium concentrations in serum, plasma, or urine on the SYNCHRON CX 3 System, and the reaction principles for both are identical. In comparison studies, a correlation coefficient of 0.982 and a regression equation of y = 0.95x + 0.54 was obtained with serum samples; and a correlation coefficient of 0.996 and a regression equation of y = 1.02x - 0.15 was obtained with urine samples. With-in run precision and total precision demonstrated %CV's of less than 2.4 % on serum samples and less than 1.5 % on urine samples. The Sigma Diagnostics Calcium Reagent has been determined to be linear to 15.5 mg/dL on the SYNCHRON CX 3 System.
REFERENCES
- Textbook of Clinical Chemistry, N Tietz, Editor, WB Saunders, Co, Philadelphia, PA, 1 . 1986
- Schmitz J, et al: Clin Chem 32: 1198, 1986 2.
§ 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.