(23 days)
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.
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 provided text describes the performance of the Sigma Diagnostics Electrolyte Reference Reagent (Procedure Number E3891) in comparison to the Beckman Electrolyte Reference Reagent Kit (Part No. 443315) on the SYNCHRON CX®3 System. The study aims to demonstrate substantial equivalence.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as defined thresholds for correlation coefficients or regression equations. Instead, it presents the achieved performance metrics as evidence of substantial equivalence to the predicate device. The implied acceptance is that the correlation and regression fall within an acceptable range for a substantially equivalent device. Similarly, for precision, the stated %CVs are the achieved performance, implying these are considered acceptable.
| Metric (Analyte, Sample Type) | Reported Sigma Diagnostics Performance | Implied Acceptance Criteria (relative to predicate) |
|---|---|---|
| Correlation Coefficient | ||
| Sodium (Serum) | 0.963 | High correlation (implied >~0.95 given the values) |
| Potassium (Serum) | 0.999 | High correlation |
| Chloride (Serum) | 0.973 | High correlation |
| Total CO2 (Serum) | 0.992 | High correlation |
| Sodium (Urine) | 0.997 | High correlation |
| Potassium (Urine) | 0.998 | High correlation |
| Chloride (Urine) | 0.997 | High correlation |
| Chloride (CSF) | 0.891 | High correlation (lower but still presented as acceptable) |
| Regression Equation (y = Sigma, x = Beckman) | ||
| Sodium (Serum) | y = 0.90x + 13.48 | Slope close to 1, intercept close to 0 (indicating good agreement) |
| Potassium (Serum) | y = 0.98x + 0.08 | Slope close to 1, intercept close to 0 |
| Chloride (Serum) | y = 0.91x + 10.52 | Slope close to 1, intercept close to 0 |
| Total CO2 (Serum) | y = 0.95x + 1.54 | Slope close to 1, intercept close to 0 |
| Sodium (Urine) | y = 0.95x - 0.10 | Slope close to 1, intercept close to 0 |
| Potassium (Urine) | y = 0.97x + 0.49 | Slope close to 1, intercept close to 0 |
| Chloride (Urine) | y = 0.97x + 2.06 | Slope close to 1, intercept close to 0 |
| Chloride (CSF) | y = 0.98x + 4.00 | Slope close to 1, intercept close to 0 |
| Precision (%CV) | ||
| Sodium (Serum) | < 1.1% (within-run & total) | Low %CV (implied acceptable precision) |
| Sodium (Urine) | < 1.2% (within-run & total) | Low %CV |
| Potassium (Serum) | < 1.0% (within-run & total) | Low %CV |
| Potassium (Urine) | < 1.6% (within-run & total) | Low %CV |
| Chloride (Serum) | < 1.3% (within-run & total) | Low %CV |
| Chloride (Urine) | < 1.9% (within-run & total) | Low %CV |
| Chloride (CSF) | < 1.8% (within-run & total) | Low %CV |
| Linearity Range (mmol/L) | ||
| Sodium (Serum) | 100.0 - 200.0 | Wide appropriate range |
| Sodium (Urine) | 10 - 200 | Wide appropriate range |
| Potassium (Serum) | 1.00 - 15.00 | Wide appropriate range |
| Potassium (Urine) | 2 - 200 | Wide appropriate range |
| Chloride (Serum) | 50.0 - 200.0 | Wide appropriate range |
| Chloride (Urine) | 15 - 300 | Wide appropriate range |
| Chloride (CSF) | 50 - 200 | Wide appropriate range |
| Total CO2 (Serum) | 5.0 - 40.0 | Wide appropriate range |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for the comparison studies. It refers to "comparison studies" and "serum samples," "urine samples," and "CSF samples" in a general sense, but no numerical count is provided.
The data provenance is also not explicitly stated. It's presented as data obtained in "comparison studies" without mentioning the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission, it would likely be prospective data collected specifically for the submission, but this is not confirmed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not applicable to this type of device and study. The "ground truth" here is the measurement obtained by the predicate device (Beckman Electrolyte Reference Reagent Kit), not an expert interpretation. This is a direct analytical comparison.
4. Adjudication Method for the Test Set:
This information is not applicable. There is no "adjudication" in the sense of resolving discrepancies between human readers or between a device and human readers. The comparison is between two analytical devices.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. This document describes an in-vitro diagnostic (IVD) device for measuring electrolytes, not an AI-assisted diagnostic imaging or interpretation system that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the study described is essentially a standalone performance evaluation of the Sigma Diagnostics Electrolyte Reference Reagent. It's comparing the device's measurements directly against those of a predicate device, without human intervention in the measurement process itself.
7. The type of ground truth used:
The "ground truth" in this context is the measurements provided by the predicate device, the Beckman Electrolyte Reference Reagent Kit, Part No. 443315, on the SYNCHRON CX®3 System. The study's purpose is to show consistency with this established method.
8. The Sample Size for the Training Set:
This information is not applicable. The device is a chemical reagent kit used for analytical measurement, not a machine learning model that requires a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the same reason as point 8.
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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 |
§ 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.