SIGMA DIAGNOSTICS GLUCOSE REAGENT

K963535 · Sigma Diagnostics, Inc. · CGA · Jan 17, 1997 · Clinical Chemistry

Device Facts

• Record ID: K963535
• Device Name: SIGMA DIAGNOSTICS GLUCOSE REAGENT
• Applicant: Sigma Diagnostics, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Jan 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The diagnosis of disorders associated with abnormal carbohydrate metabolisms depends in part on the measurement of glucose. The most significant of these diseases is diabetes mellitus, which is characterized by abnormally high concentrations of glucose in physiological fluids. Increased glucose concentration also occurs during hyperactivity of endocrine glands such as the thyroid and the adrenal. Hypoglycemia is a condition characterized by low glucose levels that can result from a variety of conditions such as insulin overdose, liver diseases, and hypopituitarism. Glucose determinations, therefore, are useful for detection and management of diabetes mellitus, and for investigation of hypoglycemic conditions.

Device Story

Reagent kit for quantitative glucose measurement; utilizes modified polarographic oxygen sensor to record oxygen consumption; operates on SYNCHRON CX3 System; used in clinical laboratory settings by trained personnel; input: serum, plasma, urine, or CSF samples; output: glucose concentration values; assists clinicians in diagnosing/managing diabetes mellitus and hypoglycemia; provides diagnostic data for endocrine disorder investigation.

Clinical Evidence

Bench testing only. Comparison studies performed on serum, urine, and CSF samples. Serum: r=0.997, y=1.01x-1.73, CV < 2.0%. Urine: r=0.976, y=0.97x-2.68, CV < 3.8%. CSF: r=0.981, y=1.02x-2.95, CV < 2.3%. Linearity established up to 900 mg/dL using ORDAC function.

Technological Characteristics

Modified polarographic oxygen sensor methodology; measures oxygen consumption; compatible with SYNCHRON CX3 System; linear range up to 900 mg/dL via ORDAC function.

Indications for Use

Indicated for quantitative measurement of glucose in serum, plasma, urine, or CSF to aid in the detection and management of diabetes mellitus and investigation of hypoglycemic conditions in patients suspected of carbohydrate metabolism disorders.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Beckman Glucose Reagent Kit, Part No. 443355

Submission Summary (Full Text)

{0}

JAN 17 1997
K963535

510(K) NOTIFICATION

Sigma Diagnostics
545 South Ewing Avenue
St. Louis, MO 63103

CX®3 Glucose Reagent
Procedure Number G4903
August 31, 1996

SUMMARY OF SAFETY AND EFFECTIVENESS

The diagnosis of disorders associated with abnormal carbohydrate metabolisms depends in part on the measurement of glucose. The most significant of these diseases is diabetes mellitus, which is characterized by abnormally high concentrations of glucose in physiological fluids. Increased glucose concentration also occurs during hyperactivity of endocrine glands such as the thyroid and the adrenal. Hypoglycemia is a condition characterized by low glucose levels that can result from a variety of conditions such as insulin overdose, liver diseases, and hypopituitarism.¹ Glucose determinations, therefore, are useful for detection and management of diabetes mellitus, and for investigation of hypoglycemic conditions.

Quantitative measurement of glucose by means of a modified polarographic oxygen sensor for recording oxygen consumption was introduced in 1969 by A. Kadish, et al.² The Sigma Diagnostics Glucose Reagent is formulated to use this methodology on the SYNCHRON CX®3 System.

The safety and effectiveness of Sigma Diagnostics Glucose Reagent, Procedure Number G4903, are demonstrated by its substantial equivalency to Beckman Glucose Reagent Kit, Part No. 443355. Both glucose reagents are used to measure glucose concentrations in serum, plasma, urine, or CSF on the SYNCHRON CX®3 System, and the reaction principles for both reagents are identical. In comparison studies, a correlation coefficient of 0.997 and a regression equation of y = 1.01x - 1.73 was obtained with serum samples; a correlation coefficient of 0.976 and a regression equation of y = 0.97x - 2.68 was obtained with urine samples; and a correlation coefficient of 0.981 and a regression equation of y = 1.02x - 2.95 was obtained with CSF samples. With-in run precision and total precision demonstrated % CV’s of less than 2.0 % on serum samples; less than 3.8 % on urine samples; and less than 2.3 % on CSF samples. The Sigma Diagnostics Glucose Reagent has been determined to be linear to 900 mg/dL using the ORDAC function on the SYNCHRON CX®3 System.

REFERENCES:

1. Searcy RL: Diagnostic Biochemistry. McGraw Hill, New York, 1969, pp 460-464
2. Kadish A, et al: J Clin Chem 14(2):16, 1968

2