ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH

K051646 · Pointe Scientific, Inc., · JGS · Oct 7, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051646
• Device Name: ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH
• Applicant: Pointe Scientific, Inc.,
• Product Code: JGS · Clinical Chemistry
• Decision Date: Oct 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1665
• Device Class: Class 2

Indications for Use

This product is to be used for the quantitative determination of Electrolytes (Sodium, Potassium and Chloride) in human serum. The determination of Electrolytes is most commonly performed for the diagnosis and treatment of diseases causing an electrolyte imbalance. Sodium determinations are offen used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addisons disease and a number of other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte imbalance in the diagnosis and treatment of diseases characterized by low and high potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Device Story

Pointe Scientific ISE reagents (Diluent, 1N KCl, Internal Reference, Standards) are aqueous solutions used with Roche Hitachi 917 analyzers. Device utilizes potentiometry to measure electromotive force changes between measuring and reference electrodes upon sample introduction. Changes in ionic concentration relative to internal reference standards allow calculation of Sodium, Potassium, and Chloride levels. Used in clinical laboratories by technicians to support diagnosis and treatment of electrolyte-related disorders. Output is quantitative electrolyte concentration, aiding clinical decision-making regarding patient metabolic status.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reagent system for ion-selective electrode (ISE) analysis. Includes ISE Diluent, 1N KCL, Internal Reference, and ISE standards (Low and High). Classified as a chloride test system under 21 CFR 862.1170 (Product Codes: CGZ, CEM, JGS).

Indications for Use

Indicated for quantitative determination of sodium, potassium, and chloride in human serum to diagnose and treat electrolyte imbalances, including aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, cystic fibrosis, and diabetic acidosis.

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.

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
k051646

B. Purpose for Submission:
This is a new submission for the clearance of ISE reagents.

C. Measurand:
Chloride, Potassium, and Sodium

D. Type of Test:
Ion Specific Electrode

E. Applicant:
Pointe Scientific, Inc.

F. Proprietary and Established Names:
ISE Diluent
1N KCl
Internal Reference and ISE Standards Low and High

G. Regulatory Information:
1. Regulation section:
21CFR Sec.-862.1170-Chloride test system.
21 CFR Sec.-862.1600-Potassium test system.
21 CFR Sec.-862.1665-Sodium test system.
2. Classification:
Class II
3. Product code:
CGZ - Electrode, Ion-Specific, Chloride
CEM - Electrode, Ion-Specific, Potassium
JGS - Electrode, Ion-Specific, Sodium
4. Panel:
Chemistry (75)

H. Intended Use:
1. Intended use(s):
Claims use in serum, plasma and urine.
2. Indication(s) for use:
This product is to be used for the quantitative determination of Electrolytes (Sodium, Potassium and Chloride) in human serum. The determination of Electrolytes is most commonly performed for the diagnosis and treatment of diseases causing an electrolyte imbalance. Sodium determinations are often used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addisons disease and a number of other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte imbalance in the diagnosis and treatment of diseases characterized by low and high potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

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3. Special conditions for use statement(s):
None

4. Special instrument requirements:
Roche Hitachi 917 analyzer

I. Device Description:
The ISE Diluent, ISE Internal Reference and 1N KCL are aqueous solutions containing an anti-microbial agent at known ionic concentration.

J. Substantial Equivalence Information:
1. Predicate device name(s):
Roche Hitachi 917 analyzer with ISE
2. Predicate 510(k) number(s):
k953239
3. Comparison with predicate:

| Contents | Roche (before reconstitution) | Pointe Scientific |
| --- | --- | --- |
| ISE Diluent: | | |
| Boric Acid | 650 mmol/L | Borate Buffer |
| Nonreactive Ingredient | preservative | anti-microbial 0.05% |
| 1N KCL: | | |
| Potassium Chloride mol/L | 1 mol/L | 1 |
| Nonreactive Ingredient | Preservative | anti-microbial 0.01% |
| Internal Reference: | | |
| Boric Acid | 650 mmol/L | Borate Buffer |
| Sodium Chloride | 32.3 mmol/L | 3.2 mmol/L |
| Sodium Bicarbonate | 12.9 mmol/L | 1.3 mmol/L |
| Potassium Phosphate | 1.6 mmol/L | 0.15mmol/L |
| Nonreactive Ingredient | preservative | anti-microbial 0.05% |
| | Thermo ALKO | Pointe Scientific |
| ISE Standard LOW | | |
| Sodium | 120 mmol/L | 120 mmol/L |
| Potassium | 3.0 mmol/L | 3.0 mmol/L |
| Chloride | 80.0 mmol/L | 80.0 mmol/L |
| ISE Standard HIGH | | |
| Sodium | 160 mmol/L | 160 mmol/L |
| Potassium | 7.0 mmol/L | 7.0 mmol/L |
| Chloride | 120.0 mmol/L | 120.0 mmol/L |

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K. Standard/Guidance Document Referenced (if applicable):
CLSI Document EP5-T2
CLSI Document EP7-P

L. Test Principle:
The measurement of these constituents (Cl, K, Na) are based on Potentiometry, which is the measurement of the change in the “electromotive force” between the measuring electrode and a reference electrode. The internal reference standard maintains a constant ionic concentration between the two electrodes. The introduction of a sample will change this concentration affecting the “electromotive force,” this difference is then used to calculate the unknown, based on known standards that are used during the calibration of the ISE analytes.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:
Within Day Precision
Day to Day Precision

Sample I (n=20), units = mmol/L
Sample I (n=20), units = mmol/L

| | Mean | S.D. | C.V.% | | Mean | S.D. | C.V.% |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Sodium | 147 | 1.07 | 0.728 | Sodium | 142 | 1.700 | 1.197 |
| Potassium | 4.7 | 0.031 | 0.660 | Potassium | 4.4 | 0.076 | 1.727 |
| Chloride | 110 | 0.98 | 0.891 | Chloride | 106 | 1.442 | 1.360 |

Sample II (n=20), units = mmol/L
Sample II (n=20), units = mmol/L

| | Mean | S.D. | C.V.% | | Mean | S.D. | C.V.% |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Sodium | 159 | 0.47 | 0.296 | Sodium | 158 | 2.700 | 1.709 |
| Potassium | 7.7 | 0.020 | 0.260 | Potassium | 7.5 | 0.151 | 2.013 |
| Chloride | 120 | 0.37 | 0.308 | Chloride | 119 | 1.842 | 1.548 |

b. Linearity/assay reportable range:
The assay range for this reagent product was determined by running commercially available Linearity standards. The Pointe Scientific ISE solutions demonstrate that they meet their linearity claims. The assay ranges are listed below.

Sodium: 80 – 180 mmol/L
Potassium: 1.5 – 10.0 mmol/L
Chloride: 45 – 140 mmol/L

c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Subject of k963734 calibrators were cleared under k963734. Controls are not the subject of this review.

d. Detection limit:
Not Applicable

e. Analytical specificity:
Interference by bilirubin, triglyceride and hemoglobin was investigated by the following modification of the recommended preparation and testing protocols in CLSI document EP7-P. Bilirubin to 30 mg/dl, Triglyceride to 1000mg/dl

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and Hemoglobin to 400 mg/dl were each demonstrated not to interfere in the ISE assays. (Less than 10.0%)

f. Assay cut-off:
Not Applicable

2. Comparison studies:
a. Method comparison with predicate device:
A comparison study was performed at Pointe Scientific investigating the relationship between values determined using the Roche Diagnostics ISE solutions, and values determined using the Pointe Scientific, Inc. ISE solutions. Pointe ISE solutions were calibrated with Thermo ALKO Standards manufactured for Pointe. This study was performed on actual patient specimens supplied by a local medical institution (Detroit Medical Ctr.). The study was performed on a Roche Diagnostics Hitachi 917 chemistry analyzer and gave the following correlation data.

| Analyte Name | Correlation Coefficient | Regression Equation |
| --- | --- | --- |
| Sodium | 0.995 | y = 0.952x + 7.29 |
| Chloride | 0.993 | y = 0.928x + 7.79 |
| Potassium | 0.998 | y = 0.996x + 0.039 |

This study was performed using 110 samples ranging from 104 to 177 for Sodium, 2.0-9.7 for Potassium and 97-145 for Chloride. These results indicate acceptable agreement between these methods on routine patient specimens encountered by the laboratory.

b. Matrix comparison:
The claim is for serum only.

3. Clinical studies:
a. Clinical Sensitivity:
Not Applicable
b. Clinical specificity:
Not Applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not Applicable

4. Clinical cut-off:
Not Applicable

5. Expected values/Reference range:
The sponsor has provided reference ranges based on recommendations in the published literature.

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.