K963541 · Sigma Diagnostics, Inc. · JFL · Oct 24, 1996 · Clinical Chemistry
Device Facts
Record ID
K963541
Device Name
SIGMA DIAGNOSTICS CO2 ACID REAGENT
Applicant
Sigma Diagnostics, Inc.
Product Code
JFL · Clinical Chemistry
Decision Date
Oct 24, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 862.1160
Device Class
Class 2
Indications for Use
The Sigma Diagnostics CO₂ Acid Reagent, Procedure Number C7558, is intended for the quantitative determination of carbon dioxide in serum or plasma on the SYNCHRON CX®3 System.
Device Story
Reagent kit for quantitative measurement of CO₂ in serum or plasma; used on SYNCHRON CX®3 System. Principle involves chemical reaction to measure dissolved CO₂ and bicarbonate anion. Used in clinical laboratory settings by technicians. Output is CO₂ concentration (mmol/L) used by physicians to assess acid-base balance and electrolyte status. Benefits include diagnostic support for metabolic/respiratory disorders.
Clinical Evidence
Bench testing only. Comparison study of Sigma Diagnostics reagent vs. predicate using serum samples yielded correlation coefficient of 0.992 and regression equation y = 0.95x + 1.54. Precision testing (within-run and total) showed %CV < 6.5%. Linearity established from 5.0 to 40.0 mmol/L.
Technological Characteristics
Chemical reagent for CO₂ determination. Operates via enzymatic/chemical reaction principle on SYNCHRON CX®3 automated analyzer. Linear range: 5.0 to 40.0 mmol/L.
Indications for Use
Indicated for the determination of plasma CO₂ content as part of an electrolyte profile to assess metabolic or respiratory acidosis or alkalosis in patients with conditions such as diabetes mellitus, glomerulonephritis, pyloric obstruction, or diarrhea.
Regulatory Classification
Identification
A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
Predicate Devices
Beckman CO₂ Acid Reagent Kit, Part No. 443330
Submission Summary (Full Text)
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OCT 24 1996
K963541
510(K) NOTIFICATION
Sigma Diagnostics
545 South Ewing Avenue
St. Louis, MO 63103
CX®3 CO₂ Acid Reagent
Procedure Number C7558
August 31, 1996
# SUMMARY OF SAFETY AND EFFECTIVENESS
Carbon dioxide (CO₂) in serum or plasma exists primarily as dissolved CO₂ and bicarbonate anion (HCO₃⁻).¹ The CO₂ content is decreased in metabolic acidosis and respiratory alkalosis, whereas the level is increased in metabolic alkalosis and respiratory acidosis.² In pathologic conditions such as in diabetes mellitus, glomerulonephritis, pyloric obstruction, or diarrhea, acidosis or alkalosis can be anticipated.³ Therefore, determination of plasma CO₂ content as part of an electrolyte profile helps establish whether, and to what degree, the anticipated change has occurred in the above patients.
The safety and effectiveness of Sigma Diagnostics CO₂ Acid Reagent, Procedure Number C7558, are demonstrated by its substantial equivalency to Beckman CO₂ Acid Reagent Kit, Part No. 443330. Both CO₂ acid reagents are used to measure carbon dioxide concentrations in serum or plasma on the SYNCHRON CX®3 System, and the reaction principles for both are identical. In comparison studies, a correlation coefficient of 0.992 and a regression equation of y = 0.95x + 1.54 was obtained with serum samples. With-in run precision and total precision on serum samples demonstrated %CV’s of less than 6.5%. The Sigma Diagnostics CO₂ Alkaline Buffer has been determined to be linear from 5.0 to 40.0 mmol/L on the SYNCHRON CX®3 System.
## REFERENCES
1. Clinical Chemistry, LA Kaplan, AJ Pesce, Editors, CV Mosby Company, St. Louis (MO) 1989
2. Hydrogen Ion Concentration in Body Fluids. IN Contarow and Trumper Clinical Biochemistry, 7th ed., AL Latner, Editor, Saunders, Philadelphia, 1975, p 399
3. Tietz, NW, Prudent EL, Siggaard-Anderson O: Electrolytes, Blood Gases, and Acid-Base Balance. IN Textbook of Clinical Chemistry, NW Tietz, Editor, Saunders, Philadelphia, 1986, p 1188
