K963538 · Sigma Diagnostics, Inc. · JFL · Oct 11, 1996 · Clinical Chemistry
Device Facts
Record ID
K963538
Device Name
SIGMA DIAGNOSTICS CO2ALKALINE BUFFER
Applicant
Sigma Diagnostics, Inc.
Product Code
JFL · Clinical Chemistry
Decision Date
Oct 11, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 862.1160
Device Class
Class 2
Indications for Use
The Sigma Diagnostics CO₂ Alkaline Buffer, Procedure Number C7683, is used to measure carbon dioxide concentrations in serum or plasma on the SYNCHRON CX®3 System.
Device Story
Reagent buffer for in vitro diagnostic measurement of CO₂ in serum/plasma; used on SYNCHRON CX®3 System. Principle: enzymatic/chemical reaction to quantify bicarbonate/dissolved CO₂. Used in clinical laboratory settings by trained technicians. Output: quantitative CO₂ concentration (mmol/L). Clinicians use results to assess acid-base balance and electrolyte status, aiding diagnosis of metabolic/respiratory disorders.
Clinical Evidence
Bench testing only. Comparison study with 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 buffer for automated clinical chemistry analyzer. Operates via colorimetric/enzymatic reaction principle on SYNCHRON CX®3 System. Linear range: 5.0-40.0 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 Alkaline Buffer Kit (Part No. 443320)
Submission Summary (Full Text)
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OCT 11 1996
K963538
510(K) NOTIFICATION
Sigma Diagnostics
545 South Ewing Avenue
St. Louis, MO 63103
CX®3 CO₂ Alkaline Buffer
Procedure Number C7683
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 Alkaline Buffer, Procedure Number C7683, are demonstrated by its substantial equivalency to Beckman CO₂ Alkaline Buffer Kit, Part No. 443320. Both CO₂ alkaline buffers 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
