SIGMA DIAGNOSTICS CALICIUM REAGENT

K963536 · Sigma Diagnostics, Inc. · CJY · Oct 10, 1996 · Clinical Chemistry

Device Facts

• Record ID: K963536
• Device Name: SIGMA DIAGNOSTICS CALICIUM REAGENT
• Applicant: Sigma Diagnostics, Inc.
• Product Code: CJY · Clinical Chemistry
• Decision Date: Oct 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1145
• Device Class: Class 2

Intended Use

The Sigma Diagnostics Calcium Reagent, Procedure Number C7183, is intended for the quantitative determination of calcium in serum, plasma, or urine on the SYNCHRON CX®3 System.

Device Story

In vitro diagnostic reagent for quantitative calcium measurement; utilizes arsenazo III method; designed for use on SYNCHRON CX®3 System. Input: serum, plasma, or urine samples. Process: chemical reaction with reagent; sample blanking on analyzer to enhance specificity; eliminates magnesium interference. Output: calcium concentration values. Used in clinical laboratories by technicians/pathologists. Results assist clinicians in diagnosing calcium-related metabolic disorders and monitoring bone/kidney function.

Clinical Evidence

Bench testing only. Comparison study against predicate using serum and urine samples. Serum: correlation coefficient 0.982, regression y=0.95x+0.54. Urine: correlation coefficient 0.996, regression y=1.02x-0.15. Precision: within-run and total precision %CV < 2.4% (serum) and < 1.5% (urine). Linearity established up to 15.5 mg/dL.

Technological Characteristics

Arsenazo III colorimetric reagent; single-reagent system. Designed for automated analysis on SYNCHRON CX®3 System. Features sample blanking to minimize magnesium interference. Linear range up to 15.5 mg/dL.

Indications for Use

Indicated for the quantitative measurement of calcium in serum, plasma, or urine to assist in the diagnosis and monitoring of diseases associated with hypercalcemia (e.g., primary hyperthyroidism, malignancy) and hypocalcemia (e.g., hypoparathyroidism, vitamin D deficiency, rickets, intestinal malabsorption).

Regulatory Classification

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).

Predicate Devices

• Beckman Calcium Reagent Kit (Part No. 450890)

Submission Summary (Full Text)

{0}

K963536

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}

K963536

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

1. Textbook of Clinical Chemistry, N Tietz, Editor, WB Saunders, Co, Philadelphia, PA, 1986
2. Schmitz J, et al: Clin Chem 32: 1198, 1986