Who is the manufacturer of SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT?

Sigma Diagnostics, Inc. filed the 510(k) submission for SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT (K963542).

What is the FDA product code for SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT?

JGS. It is classified under 21 CFR 862.1665 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT

Q: What are the predicate devices for SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT?

Beckman Electrolyte Reference Reagent Kit (Part No. 443315).

K963542 · Sigma Diagnostics, Inc. · JGS · Sep 27, 1996 · Clinical Chemistry

Device Facts

Record ID	K963542
Device Name	SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT
Applicant	Sigma Diagnostics, Inc.
Product Code	JGS · Clinical Chemistry
Decision Date	Sep 27, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1665
Device Class	Class 2

Intended Use

The Sigma Diagnostics Electrolyte Reference Reagent is intended for use on the SYNCHRON CX®3 System 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.

Device Story

The Sigma Diagnostics Electrolyte Reference Reagent is a chemical reagent used on the SYNCHRON CX®3 System to facilitate the measurement of electrolytes (sodium, potassium, chloride) and CO2. The system utilizes ion-selective electrodes for sodium, potassium, and chloride detection, and a rate of pH change method for CO2 determination. The device is used in clinical laboratory settings by trained technicians. By providing quantitative concentration data for these analytes in serum, plasma, urine, and CSF, the reagent assists clinicians in diagnosing and monitoring metabolic and renal conditions, such as heart failure, diabetes, and acid-base disturbances. The output is a numerical concentration value used to inform clinical decision-making regarding patient fluid and electrolyte management.

Clinical Evidence

Bench testing only. Performance was validated through comparative studies against the predicate device. Correlation coefficients for serum analytes ranged from 0.963 to 0.999; urine analytes from 0.997 to 0.998; and CSF chloride was 0.891. Precision studies demonstrated within-run and total precision %CVs of <1.1% for serum sodium, <1.0% for serum potassium, and <1.3% for serum chloride. Linearity ranges were established for all analytes across serum, urine, and CSF matrices.

Technological Characteristics

Reagent for use with SYNCHRON CX®3 System. Sensing principle: ion-selective electrodes for Na, K, Cl; rate of pH change for CO2. System is a clinical chemistry analyzer. No specific materials of construction or software algorithm class provided.

Indications for Use

Indicated for the quantitative determination of sodium, potassium, chloride, and carbon dioxide in serum, plasma, urine, and CSF to assist in the diagnosis and monitoring of electrolyte imbalances associated with conditions such as congestive heart failure, nephrosis, renal failure, metabolic acidosis/alkalosis, and other adrenal or metabolic disorders.

Regulatory Classification

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.

Predicate Devices

Beckman Electrolyte Reference Reagent Kit (Part No. 443315)

Related Devices

K963540 — SIGMA DIAGNOSTICS ELECTROLYTE BUFFER · Sigma Diagnostics, Inc. · Sep 27, 1996
K040971 — GENCHEM ISE ELECTROLYTE REFERENCE · Genchem, Inc. · Dec 22, 2004
K992842 — HICHEM ISE ELECTROLYTE REFERENCE · Elan Holdings, Inc. · Nov 26, 1999
K052724 — TECO ISE REAGENT SET FOR CX SYSTEM · Teco Diagnostics · Dec 14, 2005
K040977 — GENCHEM ELECTROLYTE BUFFER · Genchem, Inc. · Dec 27, 2004

Submission Summary (Full Text)

{0} K963542 SEP 27 1996 # 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 | {1} 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(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 | 3