(23 days)
443325
Not Found
No
The description focuses on ion-selective electrodes and rate of pH change, which are traditional analytical methods, and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
The device is used to measure the concentrations of certain substances in bodily fluids for diagnostic purposes, not to treat a disease or condition. Its function is analytical (measurement), not therapeutic (treatment).
Yes
Explanation: The device measures concentrations of various substances in biological samples (serum, plasma, urine, CSF), which are used for diagnostic purposes by identifying and quantifying biomarkers.
No
The device description explicitly states it uses "ion selective electrodes" and measures "rate of pH change," which are hardware components of the SYNCHRON CX 3 System, not purely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the electrolyte buffers are used to measure concentrations of various substances (sodium, chloride, potassium, carbon dioxide) in biological samples (serum, plasma, urine, CSF). This is a core function of an in vitro diagnostic device.
- Device Description: The description details the method used (ion selective electrodes and rate of pH change) to perform these measurements on a specific system (SYNCHRON CX 3 System). This further confirms its role in analyzing biological samples outside of the body.
- Performance Studies: The summary of performance studies describes evaluations of the device's accuracy and precision in measuring these analytes in biological samples. This type of testing is standard for IVD devices.
- Predicate Device: The mention of a predicate device (Beckman Electrolyte Buffer Kit) which is also an IVD, strongly suggests that this device falls into the same category.
Therefore, based on the provided information, this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The safety and effectiveness of Sigma Diagnostics Electrolyte Buffer, Procedure Number E3766, are demonstrated by its substantial equivalency to Beckman Electrolyte Buffer Kit, Part No. 443325. Both electrolyte buffers are used to measure sodium, chloride, potassium, and carbon dioxide concentrations in serum or plasma, sodium, potassium, and chloride concentrations in urine, and chloride concentrations in CSF on the SYNCHRON CX 3 System, and the reaction principles for both reagents are identical.
Product codes
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Device Description
The Sigma Diagnostics methods use ion selective electrodes for determining sodium, potassium, and chloride and rate of pH change for determing carbon dioxide on the SYNCHRON CX 3 System.
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
In comparison studies, the following data was obtained:
| Serum Analyte | Correlation Coefficient | Regression equation |
|---|---|---|
| Sodium | 0.963 | y = 0.90x + 13.48 |
| Potassium | 0.999 | y = 0.98x + 0.08 |
| Chloride | 0.973 | y = 0.91x + 10.52 |
| Total CO₂ | 0.992 | y = 0.95x + 1.54 |
| Urine Analyte | Correlation Coefficient | Regression equation |
|---|---|---|
| Sodium | 0.997 | y = 0.95x - 0.10 |
| Potassium | 0.998 | y = 0.97x + 0.49 |
| Chloride | 0.997 | y = 0.97x + 2.06 |
| CSF Analyte | Correlation Coefficient | Regression equation |
|---|---|---|
| Chloride | 0.891 | y = 0.98x + 4.00 |
With-in run precision and total precision for sodium demonstrated %CV's of less than 1.1 % on serum samples and less than 1.2 % on urine samples. With-in run precision and total precision for potassium demonstrated %CV's of less than 1.0 % on serum samples and less than 1.6 % on urine samples. With-in run precision and total precision for chloride demonstrated %CV's of less than 1.3 % on serum samples, less than 1.9 % on urine samples, and less than 1.8 % on CSF samples. The Sigma Diagnostics Electrolyte Buffer has been determined to be linear to the following limits on the SYNCHRON CX 3 System:
| Analyte | Serum (mmol/L) | Urine (mmol/L) | CSF (mmol/L) |
|---|---|---|---|
| Sodium | 100.0 - 200.0 | 10 - 200 | NA |
| Potassium | 1.00 - 15.00 | 2 - 200 | NA |
| Chloride | 50.0 - 200.0 | 15 - 300 | 50 - 200 |
| Total CO2 | 5.0 - 40.0 | NA | NA |
Key Metrics
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Predicate Device(s)
Beckman Electrolyte Buffer Kit, Part No. 443325
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
SEP 2 7 1996
510(K) NOTIFICATION
Sigma Diagnostics 545 South Ewing Avenue St. Louis, MO 63103
CX®3 Electrolyte Buffer Procedure Number E3766 August 31, 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
Increased sodium levels are seen in congestive heart failure, nephrosis, hyperlipidemia and hyperglycemia. Decreased levels can be observed with excessive sweating and vomiting, with different types of diabetes, and with use of diuretic drugs.
Increased potassium levels can be due to renal failure and decrease mineralocorticoid activity such as in Addison's disease. Decreased potassium levels can be caused by renal and adrenal conditions with metabolic alkalosis or acidosis.
Increased chloride levels may be due to hyperparathyroidism. Low levels may be due to Addison's disease, intestinal obstruction, rickettsial disease and Waterhouse-Friderichsen Syndrome.
The CO, content is decreased in metabolic acidosis and respiratory alkalosis, whereas the level is increased in metabolic alkalosis and respiratory acidosis.
The Sigma Diagnostics methods use ion selective electrodes for determining sodium, potassium, and chloride and rate of pH change for determing carbon dioxide on the SYNCHRON CX 3 System.
The safety and effectiveness of Sigma Diagnostics Electrolyte Buffer, Procedure Number E3766, are demonstrated by its substantial equivalency to Beckman Electrolyte Buffer Kit, Part No. 443325. Both electrolyte buffers are used to measure sodium, chloride, potassium, and carbon dioxide concentrations in serum or plasma, sodium, potassium, and chloride concentrations in urine, and chloride concentrations in CSF on the SYNCHRON CX 3 System, and the reaction principles for both reagents are identical. In comparison studies, the following data was obtained:
| Serum Analyte | Correlation Coefficient | Regression equation |
|---|---|---|
| Sodium | 0.963 | y = 0.90x + 13.48 |
| Potassium | 0.999 | y = 0.98x + 0.08 |
| Chloride | 0.973 | y = 0.91x + 10.52 |
| Total CO₂ | 0.992 | y = 0.95x + 1.54 |
| Urine Analyte | Correlation Coefficient | Regression equation |
| Sodium | 0.997 | y = 0.95x - 0.10 |
| Potassium | 0.998 | y = 0.97x + 0.49 |
| Chloride | 0.997 | y = 0.97x + 2.06 |
1
510(K) NOTIFICATION
Sigma Diagnostics 545 South Ewing Avenue St. Louis, MO 63103
CX®3 Electrolyte Buffer Procedure Number E3766 August 31, 1996
SUMMARY OF SAFETY AND EFFECTIVENESS(cont.)
| CSF Analyte | Correlation Coefficient | Regression equation |
|---|---|---|
| Chloride | 0.891 | $y = 0.98x + 4.00$ |
With-in run precision and total precision for sodium demonstrated %CV's of less than 1.1 % on serum samples and less than 1.2 % on urine samples. With-in run precision and total precision for potassium demonstrated %CV's of less than 1.0 % on serum samples and less than 1.6 % on urine samples. With-in run precision and total precision for chloride demonstrated %CV's of less than 1.3 % on serum samples, less than 1.9 % on urine samples, and less than 1.8 % on CSF samples. The Sigma Diagnostics Electrolyte Buffer has been determined to be linear to the following limits on the SYNCHRON CX 3 System:
| Analyte | Serum (mmol/L) | Urine (mmol/L) | CSF (mmol/L) |
|---|---|---|---|
| Sodium | 100.0 - 200.0 | 10 - 200 | NA |
| Potassium | 1.00 - 15.00 | 2 - 200 | NA |
| Chloride | 50.0 - 200.0 | 15 - 300 | 50 - 200 |
| Total CO2 | 5.0 - 40.0 | NA | NA |