(37 days)
Beckman Calcium Reagent Kit, Part No. 450890
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No
The summary describes a chemical reagent kit for measuring calcium levels, with performance metrics related to correlation, precision, and linearity, which are typical for laboratory assays and do not indicate the use of AI/ML.
No
The device is a reagent kit used for diagnostic testing (measuring calcium levels in serum and urine), not for treating a condition.
Yes.
The device's performance studies involve correlation coefficients and regression equations for serum and urine samples, as well as precision measurements, indicating that it is designed to measure calcium levels in biological samples, which is a diagnostic function.
No
The summary describes a reagent kit used with a laboratory analyzer, not a software-only medical device.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Performance Studies: The description of performance studies focuses on analytical performance metrics like correlation coefficients, regression equations, and precision (%CV) using serum and urine samples. These are typical evaluations for IVD reagents used to measure analytes in biological fluids.
- Predicate Device: The predicate device listed is a "Beckman Calcium Reagent Kit." Reagent kits used for measuring substances in biological samples are classic examples of IVDs.
- Lack of other information: While the "Intended Use / Indications for Use" is not found, the nature of the performance studies and the predicate device strongly suggest the device is a reagent intended for in vitro diagnostic testing.
The absence of information about imaging, AI/ML, anatomical sites, or patient age ranges further supports the conclusion that this is a laboratory-based diagnostic test rather than an imaging or AI-driven medical device.
N/A
Intended Use / Indications for Use
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.
Product codes
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Device Description
The arsenazoIII method is a relatively new single reagent method. 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratory
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Beckman Calcium Reagent Kit, Part No. 450890
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
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
1
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.