(23 days)
Beckman Electrolyte Reference Reagent Kit, Part No. 443315
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No
The summary describes a chemical reagent used with a laboratory analyzer and does not mention any AI or ML components.
No.
This device is an in-vitro diagnostic reagent used to measure analyte concentrations in biological samples, not to treat or cure a disease.
No.
The device is a reference reagent used to measure concentrations in biological fluids, which are inputs to diagnostic systems. It is not itself a diagnostic device that interprets results to diagnose or rule out a disease.
No
The device description explicitly states the use of "ion selective electrodes" and "rate of pH change," which are hardware components used in the SYNCHRON CX®3 System for measuring analytes. The device is a reagent kit used with a specific hardware system, not a standalone software product.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the reagent is used to measure concentrations of various analytes (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 to perform these measurements (ion selective electrodes and rate of pH change), which are analytical techniques applied to biological samples.
- Performance Studies: The document includes performance data such as correlation coefficients, regression equations, and precision (%CV) obtained from testing the reagent with biological samples. This type of data is characteristic of the evaluation of an IVD.
- Reference Device: The mention of a reference device (Beckman Electrolyte Reference Reagent Kit) further indicates that this is a product intended for use in a laboratory setting for diagnostic purposes, as it is being compared to an existing IVD.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. This description clearly aligns with the purpose and function of the Sigma Diagnostics Electrolyte Reference Reagent.
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Intended Use / Indications for Use
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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 determining 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison studies were performed:
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
Within-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.
Within-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.
Within-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 Reference Reagent 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 (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Beckman Electrolyte Reference Reagent Kit, Part No. 443315
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.
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510(K) NOTIFICATION
Sigma Diagnostics 545 South Ewing Avenue St. Louis, MO 63103
CX 3 Electrolye Reference Reagent Procedure Number E3891 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 CO2 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 determining carbon dioxide on the SYNCHRON CX®3 System.
The safety and effectiveness of Sigma Diagnostics Electrolyte Reference Reagent, Procedure Number E3891, are demonstrated by its substantial equivalency to Beckman Electrolyte Reference Reagent Kit, Part No. 443315. Both electrolyte reference reagents 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 |
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510(K) NOTIFICATION
Sigma Diagnostics 545 South Ewing Avenue St. Louis, MO 63103
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 Reference Reagent 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 |