(37 days)
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No
The summary describes a chemical reagent kit for measuring carbon dioxide, not a software or hardware device that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or any other indicators of AI/ML technology.
No
Explanation: The device is intended to measure carbon dioxide concentrations, which is a diagnostic function, not a therapeutic one. It provides information for diagnosis but does not treat or prevent a disease.
Yes
The device is used to measure carbon dioxide concentrations in serum or plasma, which provides information about a patient's physiological state and can aid in diagnosis.
No
The device description explicitly states "CO2 Alkaline Buffer, Procedure Number C7683", which is a chemical reagent, 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 is "to measure carbon dioxide concentrations in serum or plasma". This clearly indicates that the device is used to examine specimens derived from the human body (serum or plasma) to provide information for diagnostic purposes (measuring carbon dioxide concentrations).
- Device Description: The device is described as "CO2 Alkaline Buffer". This is a reagent used in a laboratory setting to perform a test on a biological sample.
- Performance Studies: The description includes performance data like correlation coefficients, regression equations, precision (%CV), and linearity. These are typical metrics used to evaluate the performance of an IVD device.
- Predicate Device: The mention of a "Predicate Device(s)" which is another "CO2 Alkaline Buffer Kit" further confirms that this device falls under the category of IVDs, as predicate devices are used for comparison in regulatory submissions for IVDs.
All these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
Carbon dioxide (CO2) in serum or plasma exists primarily as dissolved CO2 and bicarbonate anion (HCO2). The CO2 content is decreased in metabolic acidosis and respiratory alkalosis, whereas the level is increased in metabolic alkalosis and respiratory acidosis. In pathologic conditions such as in diabetes mellitus, glomerulonephritis, pyloric obstruction, or diarrhea, acidosis or alkalosis can be anticipated. 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
No
Mentions AI, DNN, or ML
No
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
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 CO, Alkaline Buffer has been determined to be linear from 5.0 to 40.0 mmol/L on the SYNCHRON CX 3 System.
Key Metrics
correlation coefficient of 0.992, regression equation of y = 0.95x + 1.54, %CV's of less than 6.5 %, linear from 5.0 to 40.0 mmol/L
Predicate Device(s)
Beckman CO2 Alkaline Buffer Kit, Part No. 443320
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 11 1996
510(K) NOTIFICATION
Sigma Diagnostics 545 South Ewing Avenue St. Louis, MO 63103
CX 3 CO, 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 (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 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 CO, 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