(50 days)
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No
The summary describes a chemical reagent for a laboratory analyzer and does not mention any AI or ML components or functionalities.
No.
The device is a reagent used to measure carbon dioxide concentrations, which is a diagnostic function, not a therapeutic one.
Yes
The device is used to measure carbon dioxide concentrations in serum or plasma, which provides information about a patient's health status, making it a diagnostic tool.
No
The device description explicitly states "CO2 Acid Reagent, Procedure Number C7558," indicating a chemical reagent, which is a physical component, not software. The performance studies also describe chemical analysis results.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "Used to measure carbon dioxide concentrations in serum or plasma". Serum and plasma are biological samples taken from the human body.
- Device Description: It is a "CO2 Acid Reagent", which is a chemical substance used in a laboratory setting to perform a diagnostic test.
- Performance Studies: The document describes performance studies conducted on "serum samples", further confirming its use with biological specimens.
- Predicate Device: The predicate device is also a "CO2 Acid Reagent Kit", indicating it's a similar diagnostic product.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
Carbon dioxide (CO-) in serum or plasma exists primarily as dissolved CO2 and bicarbonate anion (HCO2).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.
Product codes
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Device Description
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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
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Intended User / Care Setting
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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 0.992 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1160 Bicarbonate/carbon dioxide test system.
(a)
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.(b)
Classification. Class II.
0
OCT 2 4 1996
510(K) NOTIFICATION
Sigma Diagnostics 545 South Ewing Avenue St. Louis, MO 63103
CX®3 CO, Acid Reagent Procedure Number C7558 August 31, 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
Carbon dioxide (CO-) in serum or plasma exists primarily as dissolved CO2 and bicarbonate anion (HCO2).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
- Clinical Chemistry, LA Kaplan, AJ Pesce, Editors, CV Mosby Company, St. Louis (MO) 1. 1989
- Hydrogen Ion Concentration in Body Fluids. IN Contarow and Trumper Clinical 2. Biochemistry, 7 th ed., AL Latner, Editor, Saunders, Philadelphia, 1975, p 399
- Tietz, NW, Prudent EL, Siggaard-Anderson O: Electrolytes, Blood Gases, and Acid-Base 3. Balance. IN Textbook of Clinical Chemistry, NW Tietz, Editor, Saunders, Philadelphia, 1986, p 1188