SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)

K171476 · Awareness Technology, Inc. · JGS · Feb 27, 2018 · Clinical Chemistry

Device Facts

• Record ID: K171476
• Device Name: SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)
• Applicant: Awareness Technology, Inc.
• Product Code: JGS · Clinical Chemistry
• Decision Date: Feb 27, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1665
• Device Class: Class 2

Intended Use

The SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) is an in vitro device intended to be used for the measurement of ionized Sodium (Na+), Potassium (K+), and Chloride (Cl-) in serum and lithium heparin venous whole blood samples. The measurements are to be conducted by a trained professional in a clinical laboratory. For in-vitro diagnostic use only. The SelectaLyte Sodium (Na+) assay is intended to measure sodium. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. The SelectaLyte Potassium (K+) assay is intended to measure potassium. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. The SelectaLyte Chloride (Cl-) assays is intended to measure chloride. Measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Device Story

SelectaLyte Electrolyte Analyzer (Model 3910) is an automated, microprocessor-controlled, in vitro diagnostic device for measuring Na+, K+, and Cl- in serum and lithium heparin venous whole blood. It utilizes ion-selective electrode (ISE) technology; sodium electrode uses a sodium-sensitive glass tube; potassium electrode uses neutral carrier ionophore membranes; chloride electrode uses a covalently bound ionophore. The device performs automatic 1-point calibration per measurement and 2-point calibration every 4 hours using a reagent pack. It features an interactive LCD touch screen, patient data storage, and thermal printer output. Operated by trained laboratory professionals in clinical settings, the device provides quantitative electrolyte results to assist in the diagnosis and management of electrolyte imbalances and metabolic disorders. It does not contact the patient.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP05-A2 (N=80 for serum, N=40 for whole blood). Linearity confirmed per CLSI EP06-A. Interference testing per CLSI EP07-A2 identified specific interferents (e.g., hemolysis, sodium bromide, sodium iodide). Method comparison (N=100 per matrix) against predicate showed strong correlation (r² > 0.98 for all analytes).

Technological Characteristics

Ion selective electrode (ISE) technology. Sodium electrode: glass tube; Potassium electrode: neutral carrier ionophore membranes; Chloride electrode: covalently bound ionophore. Reference: Ag/AgCl electrode. Dimensions: 85 μL sample volume. Connectivity: Standalone, manual specimen entry. Software: Microprocessor-controlled, moderate level of concern.

Indications for Use

Indicated for trained clinical laboratory professionals to measure ionized Sodium, Potassium, and Chloride in serum and lithium heparin venous whole blood for monitoring electrolyte balance and diagnosing/treating related metabolic, renal, and cardiovascular 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

• AVL 9180 Electrolyte Analyzer (k961458)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

February 27, 2018

Awareness Technology, Inc. Steve Andrus Quality Assurance Manager 1935 SW Martin Hwy Palm City, FL 34990

Re: K171476

Trade/Device Name: SelectaLvte Electrolyte Analyzer (Na+, K+, Cl-) Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium test system Regulatory Class: Class II Product Code: JGS, CEM, CGZ, JJE Dated: December 29, 2017 Received: January 18, 2018

Dear Steve Andrus:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR

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Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Kellie B. Kelm -S

for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) k171476

Device Name

SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)

## Indications for Use (Describe)

The SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) is an in vitro device intended to be used for the measurement of ionized Sodium (Na+), Potassium (K+), and Chloride (Cl-) in serum and lithium heparin venous whole blood samples. The measurements are to be conducted by a trained professional in a clinical laboratory. For in-vitro diagnostic use only.

The SelectaLyte Sodium (Na+) assay is intended to measure sodium. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

The SelectaLyte Potassium (K+) assay is intended to measure potassium. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

The SelectaLyte Chloride (Cl-) assays is intended to measure chloride. Measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="border: 1px solid black; padding: 0px 2px;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="border: 1px solid black; padding: 0px 2px;"></span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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#### 5 510(k)171476 Summary

| Applicant: | Awareness Technology<br>1935 SW Martin Highway<br>Palm City, FL 34990 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Steve Andrus<br>Quality Assurance Manager<br>Phone: [phone] ext. 220<br>Fax: [phone]<br>Email: [e-mail] |
| Date of Preparation: | 02/22/2018 |
| Trade Name:<br>Common Name: | SelectaLyte™ Electrolyte Analyzer (Na+, K+, Cl-)<br>Ion-specific electrolyte analyzer for sodium, potassium and chloride |

| Product Nomenclature | Class | Product Code | Regulation Number | Review Panel |
|---------------------------------------------------------------------|-------|--------------|-------------------|--------------------|
| Electrode, Ion-Specific,<br>Sodium | II | JGS | 862.1665 | Clinical Chemistry |
| Electrode, Ion-Specific,<br>Potassium | II | CEM | 862.1600 | Clinical Chemistry |
| Electrode, Ion-Specific,<br>Chloride | II | CGZ | 862.1170 | Clinical Chemistry |
| Analyzer, Chemistry<br>(Photometric, Discrete),<br>For Clinical Use | I | JJE | 862.2160 | Clinical Chemistry |

# Substantial Equivalence

Awareness Technology is claiming substantial equivalence to the predicate device, AVL 9180 Electrolyte Analyzer, 510(k) number K961458.

# Description

The SelectaLyte™ Electrolyte Analyzer (Na*, K*, Cl) is an automated, microprocessor-controlled electrolyte analyzer for measurement of Sodium (Na*), and Chloride (Cl`) in serum, whole blood and QC aqueous solutions. The SelectaLyte™ Electrolyte Analyzer (Na*, K*, Cl') utilizes ion selective electrodes (ISE) to measure test samples, and display the results automatically. The instrument features automatic and on-demand calibration, patient data storage, and interactive LCD touch screen.

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## Indications of Use

The Selectalyte™ Electrolyte Analyzer (Na+, K+, Cl-) is an in vitro device intended to be used for the measurement of ionized Sodium (Na+), Potassium (K+), and Chloride (Cl-) in serum and lithium heparin venous whole blood samples. The measurements are to be conducted by a trained professional in a clinical laboratory.

For in vitro diagnostic use only.

The SelectaLyte Sodium (Na+) assay is intended to measure sodium. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

The SelectaLyte Potassium (K+) assay is intended to measure potassium. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

The SelectaLyte Chloride (Cl-) assays is intended to measure chloride. Measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

# Principles of Measurement

The principles of measurement used in the SelectaLyte™ Electrolyte Analyzer (Na*, K*, Cl'), Model 3910 are identical to the principles existing in the electrolyte analyzer to which substantial equivalence is claimed.

The SelectaLyte™ Electrolyte Analyzer (Na*, K*, Cl`) measures sodium, potassium, and chloride in dialysate using ion selective electrode technology. The sodium electrode contains a glass tube, specially formulated to be sensitive to sodium ions. The potassium electrode incorporates neutral carrier ionophore membranes which are highly selective for their respective ions. The chloride electrode contains an ionophore covalently bound to a substrate which is sensitively charged ins. The potential of each electrode is measured relative to a fixed, stable reference established by a silver/silver chloride electrode in concentrated salt solution. The measured potential varies with the concentration of the ion sensed by the electrode.

# Calibration

The SelectaLyte™ Electrolyte Analyzer (Na*, K`, Cl`), Model 3910 preforms a 2-point calibration every 4 hours and by request with a known fluid from the SelectaLyte™ Reagent Pack. A 1-point calibration is preformed automatically during each measurement.

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| Model | SelectaLyte | AVL |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Awareness Technology Inc. | Roche Diagnostic AVL 9180 |
| Technology | Ion Selective Electrode | Ion Selective Electrode |
| Intended Use | The SelectaLyte Electrolyte Analyzer<br>(Na+, K+, Cl-) is designed for clinical<br>laboratory use by laboratory<br>professionals to assess the levels of<br>Sodium, Potassium, and Chloride<br>found in serum and lithium heparin<br>venous whole blood. The analysis is<br>performed in-vitro, and neither the<br>analyzer nor any of its components<br>come in contact with the patient. The<br>instrument should be used in<br>laboratories that routinely conform to<br>government regulations or<br>accreditation requirements for quality.<br>On each day of use, analyze the<br>SelectaLyte™ Quality Control Kit Tri<br>Level at least once. | The AVL 9180 Electrolyte<br>Analyzer is intended to be used<br>for the measurement of sodium,<br>potassium, chloride, ionized<br>calcium and lithium in whole<br>blood, serum or plasma, urine,<br>dialysate solutions, or QC<br>materials as appropriate by<br>minimally trained personnel<br>qualified to preform and to<br>report these values in a clinical<br>laboratory setting. These<br>analytes are commonly used in<br>the diagnosis and management<br>of patients with a broad range of<br>renal, metabolic and<br>cardiovascular disorders and, as<br>such, have come to be among<br>those which are considered by<br>the American Association of<br>Clinical Chemistry to have a<br>potential of being life |
| Electrolytes Measured | Sodium (Na+), Potassium (K+), and<br>Chloride (Cl-) | threatening if left uncontrolled.<br>Sodium (Na+), Potassium (K+),<br>Chloride (Cl-), Lithium(Li+),<br>Calcium(Ca2+) |
| Samples Type Measured | Serum and lithium heparin venous<br>whole blood | Whole blood, serum or plasma,<br>urine, dialysate solutions, or QC<br>materials |
| Sample Volume | 85 µL | 95 µL |
| Sample Detection Sensor | Yes | No |
| SE Sample Measurement<br>Range for all Types | Na+: 40 - 205 mmol/L<br>K+: 1.5 – 15.0 mmol/L<br>Cl-: 50 - 200 mmol/L | Na+: 40 - 205 mmol/L<br>K+: 1.5 – 15.0 mmol/L<br>Cl-: 50 - 200 mmol/L |
| Model | SelectaLyte | AVL |
| Reagent Pack | Cal Standard: 650mL<br>SLOPE Standard: 125mL<br>Reference Solution: 125 mL<br>Waste bag | Standard A 350 mL<br>Standard B 85 mL<br>Reference Solution 85 mL<br>Waste bag |
| Results Storage | Sample Results: 200<br>QC Results: 270 | Sample Results: 200<br>QC Results: 35 |
| Display | Interactive touch screen 8.9cm<br>(3.5") LCD, color graphic display | 32 character, 2 line display |
| Output | Thermal printer with graphic<br>capability, 29-character width.<br>USB Memory Stick | Thermal paper<br>32 character, 2-line<br>alphanumeric display |
| Power Requirements: | 100-240VAC, 50/60Hz 55W<br>maximum | 100-115 - VAC 50-60 Hz, 0.8 A |

# Predicate Comparison

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# Predicate Comparison Continued

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## Precision Study

In accordance with CLSI EP05-A2 precision evaluation of within-run (Sr), between-run (Srr), and within-lab (ST) precision was determined using two machines and multiple users for 2 runs per day over the duration of 20 days for each matrix.

| The procision recults for Sodium | | |
|----------------------------------|--|--|

| Pooled<br>Human<br>Serum | N | Mean<br>(mmol/L) | Within Run | | Run to Run | | Within Lab | |
|--------------------------|----|------------------|----------------|-----------|----------------|-----------|----------------|-----------|
| | | | SD<br>(mmol/L) | CV<br>(%) | SD<br>(mmol/L) | CV<br>(%) | SD<br>(mmol/L) | CV<br>(%) |
| (Level 1) | 80 | 95.2 | 0.27 | 0.29% | 0.53 | 0.55% | 0.78 | 0.82% |
| (Level 2) | 80 | 134.7 | 0.33 | 0.25% | 0.59 | 0.44% | 0.72 | 0.54% |
| (Level 3) | 80 | 178.8 | 0.28 | 0.16% | 1.38 | 0.77% | 1.51 | 0.84% |

### The precision results for Potassium

| Pooled<br>Human<br>Serum | N | Mean<br>(mmol/L) | Within Run | | Run to Run | | Within Lab | |
|--------------------------|----|------------------|----------------|-----------|----------------|-----------|----------------|-----------|
| | | | SD<br>(mmol/L) | CV<br>(%) | SD<br>(mmol/L) | CV<br>(%) | SD<br>(mmol/L) | CV<br>(%) |
| (Level 1) | 80 | 2.77 | 0.02 | 0.64% | 0.01 | 0.43% | 0.02 | 0.79% |
| (Level 2) | 80 | 4.01 | 0.02 | 0.52% | 0.02 | 0.51% | 0.03 | 0.78% |
| (Level 3) | 80 | 6.59 | 0.02 | 0.24% | 0.06 | 0.90% | 0.06 | 0.97% |

#### The precision results for Chloride

| Pooled<br>Human<br>Serum | N | Mean<br>(mmol/L) | Within Run | | Run to Run | | Within Lab | |
|--------------------------|----|------------------|----------------|-----------|----------------|-----------|----------------|-----------|
| | | | SD<br>(mmol/L) | CV<br>(%) | SD<br>(mmol/L) | CV<br>(%) | SD<br>(mmol/L) | CV<br>(%) |
| (Level 1) | 80 | 63.2 | 0.29 | 0.46% | 0.30 | 0.48% | 0.58 | 0.91% |
| (Level 2) | 80 | 90.1 | 0.31 | 0.34% | 0.62 | 0.69% | 0.74 | 0.82% |
| (Level 3) | 80 | 114.4 | 0.30 | 0.26% | 0.98 | 0.86% | 1.06 | 0.93% |

Precision values for whole blood reported from testing with calibrations every consecutive replicates of 10 to total 40 replicates for each sample.

| Human<br>Whole<br>Blood | N | Mean<br>(mmol/L) | Within Run | | Within Lab | |
|-------------------------|----|------------------|------------------|-------|------------------|-------|
| (Level 1) | 40 | 98.9 | 0.69<br>(mmol/L) | 0.70% | 0.42<br>(mmol/L) | 0.43% |
| (Level 2) | 40 | 136.8 | 0.58<br>(mmol/L) | 0.42% | 0.32<br>(mmol/L) | 0.24% |
| (Level 3) | 40 | 161.0 | 0.35<br>(mmol/L) | 0.22% | 0.23<br>(mmol/L) | 0.14% |

#### The precision results for Sodium

#### The precision results for Potassium

| Pooled<br>Human<br>Serum | N | Mean<br>(mmol/L) | Within Run | | Within Lab | |
|--------------------------|----|------------------|----------------|-----------|----------------|-----------|
| | | | SD<br>(mmol/L) | CV<br>(%) | SD<br>(mmol/L) | CV<br>(%) |
| (Level 1) | 40 | 2.14 | 0.03 | 1.33% | 0.03 | 1.27% |
| (Level 2) | 40 | 3.29 | 0.07 | 2.03% | 0.07 | 2.07% |
| (Level 3) | 40 | 7.78 | 0.06 | 0.79% | 0.08 | 1.07% |

#### The precision results for Chloride

| Human<br>Whole<br>Blood | N | Mean<br>(mmol/L) | Within Run | | Within Lab | |
|-------------------------|----|------------------|----------------|-----------|----------------|-----------|
| | | | SD<br>(mmol/L) | CV<br>(%) | SD<br>(mmol/L) | CV<br>(%) |
| (Level 1) | 40 | 69.5 | 0.88 | 1.26% | 0.57 | 0.81% |
| (Level 2) | 40 | 104.4 | 0.95 | 0.91% | 0.52 | 0.50% |
| (Level 3) | 40 | 129.9 | 0.70 | 0.54% | 0.53 | 0.40% |

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## Linearity Study

In accordance with CLSI EP06-A equally spaced intermediate concentration samples were prepared accurately by proportionately mixing high and low concentration pools. 4 replicates were read at each level. The testing duration for each analyte was processed on the same day. Acceptable performance criteria by CLIA 88 in 42 CFR 493-931 Routine Chemistry.

| Linearity Summary Matrix: Serum | | | | | | |
|-----------------------------------|----------------|--------|-----------|----------------------------|--------------------------|------------------------------|
| Analyte | # of<br>Levels | Slope | Intercept | Correlation<br>Coefficient | Tested Range<br>(mmol/L) | Reportable Range<br>(mmol/L) |
| Sodium | 10 | 0.9878 | -3.8077 | 0.9988 | 35.9-203.5 | 40-205 |
| Potassium | 11 | 1.0103 | -0.1360 | 0.9999 | 1.26-19.62 | 1.5-15.0 |
| Chloride | 11 | 0.9990 | -1.3194 | 0.9999 | 30.1-202.3 | 50-200 |

Linearity Summary | Matrix: Serum

#### Linearity Summary | Matrix: Whole Blood

| Analyte | # of<br>Levels | Slope | Intercept | Correlation<br>Coefficient | Tested Range<br>(mmol/L) | Reportable Range<br>(mmol/L) |
|-----------|----------------|--------|-----------|----------------------------|--------------------------|------------------------------|
| Sodium | 11 | 1.0064 | -4.2822 | 0.9995 | 33-217.5 | 40-205 |
| Potassium | 11 | 1.0083 | -0.4117 | 0.9993 | 1.45-18.49 | 1.5-15.0 |
| Chloride | 10 | 1.0003 | 0.3451 | 1.0000 | 33.4-214.6 | 50-200 |

## Method Correlation Study

In accordance with CLSI EPO9-A2 Method comparison to the predicate device was performed with each matrix for each analyte. 10% of the samples were spiked or diluted to fully span the claimed measuring ranges.

#### Method Correlation Summary Data

| Method Correlation Summary Data | | | | | | Matix: Serum | |
|---------------------------------|-----|-------|-----------|--------|------|--------------------------|------------------------------|
| Analyte | N | Slope | Intercept | R^2 | Syx | Tested Range<br>(mmol/L) | Reportable Range<br>(mmol/L) |
| Sodium | 100 | 0.971 | 2.794 | 0.9869 | 2.37 | 43.3-194.2 | 40-205 |
| Potassium | 100 | 1.014 | -0.165 | 0.9959 | 2.37 | 1.51-14.72 | 1.5-15.0 |
| Chloride | 100 | 0.950 | 6.143 | 0.9854 | 2.36 | 55-192.6 | 50-200 |

Matix: Whole Blood

| Analyte | N | Slope | Intercept | R^2 | Syx | Tested Range<br>(mmol/L) | Reportable Range<br>(mmol/L) |
|-----------|-----|-------|-----------|--------|------|--------------------------|------------------------------|
| Sodium | 100 | 1.002 | -1.600 | 0.9865 | 1.91 | 43.3-204.6 | 40-205 |
| Potassium | 100 | 1.028 | -0.205 | 0.9946 | 1.91 | 1.58-14.84 | 1.5-15.0 |
| Chloride | 100 | 0.953 | 4.923 | 0.9806 | 1.88 | 53-192.2 | 50-200 |

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## Interference Study

In accordance with CLSI EP07-A2 The interference study is an evaluation of the effects of potentially interfering substances to decrease medically significant error within the laboratory and identify potential hazards. Interferent substances were chosen that have the potential to interfere with analytes (sodium, potassium, chloride) as reference and Drug Interference and Drug Effects in Clinical Chemistry E5 by Tryding. Each interferent was tested higher than the therapeutic concentration of the relevant drug; then evaluated to show the degree of interference.

The highest concentration of each interferent that did not show interference for the serum sodium, potassium, and chloride assays is shown in the table below.

| Analyte | Interferent | Highest concentration tested that did<br>not show significant interference |
|-----------------|----------------------|----------------------------------------------------------------------------|
| Serum Sodium | Bilirubin Conjugate | 1000.0 mg/dL |
| | Cholesterol | 503.1 mg/dL |
| | Hemoglobin | 200.0 mg/dL |
| | Isoniazid | 4.0 mg/dL |
| | Lithium Acetate | 21.1 mg/dL |
| | Magnesium Acetate | 213.6 mg/dL |
| | Metronidazole | 12.0 mg/dL |
| Serum Potassium | Bilirubin Conjugate | 1000.0 mg/dL |
| | Cholesterol | 503.1 mg/dL |
| | Hemoglobin | 200.0 mg/dL |
| | Isoniazid | 4.0 mg/dL |
| | Lithium Acetate | 21.1 mg/dL |
| | Magnesium Acetate | 213.6 mg/dL |
| | Metronidazole | 12.0 mg/dL |
| | Sodium Fluoride | 0.33 mg/dL |
| | Sodium Heparin | 3000.0 U/L |
| | Sodium Iodide* | 5.6 mg/dL |
| | Triglycerides | 2364.3 mg/dL |
| | Vancomycin | 10.3 mg/dL |
| Serum Chloride | Acetylcysteine | 166.5 mg/dL |
| | Acetylsalicylic Acid | 65.2 mg/dL |
| | Ampicillin | 5.3 mg/dL |
| | Bilirubin Conjugate | 1000.0 mg/dL |
| | Cefoxitin | 69.5 mg/dL |
| | Cholesterol | 200.0 mg/dL |
| | Doxycycline | 3.2 mg/dL |
| | EDTA | 0.13 mg/dL |
| | Hemoglobin | 200.0 mg/dL |
| | Ibuprofen | 55.4 mg/dL |
| | Isoniazid | 4.0 mg/dL |
| | Lithium Acetate | 21.1 mg/dL |
| | Magnesium Acetate | 213.6 mg/dL |
| | Metronidazole | 12.0 mg/dL |
| | Paracetamol | 20.0 mg/dL |

## Interference Effect Summary Data

*Continued Interference

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| Analyte | Interferent | Highest concentration tested that did<br>not show significant interference |
|----------------|-----------------------|----------------------------------------------------------------------------|
| Serum Chloride | pH (High) | ~8.0 |
| | Potassium Thiocyanate | 25.1 mg/dL |
| | Rifampicin | 6.4 mg/dL |
| | Sodium Bicarbonate | 294.0 mg/dL |
| | Sodium Bromide* | 24.1 mg/dL |
| | Sodium Fluoride | 0.33 mg/dL |
| | Sodium Heparin | 3000.0 U/L |
| | Sodium Iodide | 5.6 mg/dL |
| | Triglycerides | 2364.3 mg/dL |
| | Vancomycin | 10.3 mg/dL |

## Interference Effect Summary Data

*Continued Interference

## Serum Interference Observations

Cholesterol showed interference with Chloride assay at concentrations 503 mg/dL, 251 mg/dL with a bias greater than 3.4mmol/L.

Potassium Thiocyanate showed interference with Chloride assay at concentrations 66.9 mg/dL, 33.4 mg/dL, with a bias greater than 4.3mmol/L.

Sodium Bromide showed interference with Chloride assay at all concentrations tested with a bias greater than 4.5mmol/L.

Sodium Fluoride showed interference with Chloride and Potassium assays at concentration 0.44mg/dL with a bias of 12.4mmol/L for chloride and 0.64mmol/L for potassium.

Sodium Iodide showed interference with Chloride and Potassium assays at concentration 44.8mg/dL, 22.5 mg/dL, 11.2mg/dL, with a bias of 3.3mmol/L for chloride and continued interference for potassium with a bias greater than 0.24mmol/L.

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The highest concentration of each interferent that did not show interference for the whole blood sodium, potassium, and chloride assays is shown in the table below.

| Analyte | Interferent | Highest concentration tested that did<br>not show significant interference |
|-----------------------|----------------------------------|----------------------------------------------------------------------------|
| Whole Blood Sodium | Acetone | 69.7 mg/dL |
| | Acetylsalicylic Acid | 59.1 mg/dL |
| | Benzalkonium Chloride | 0.67 mg/dL |
| | Bilirubin Conjugate | 1000.0 mg/dL |
| | Bilirubin, Total | 20.0 mg/dL |
| | Cholesterol | 503.1 mg/dL |
| | Creatinine | 5.0 mg/dL |
| | Ethanol | 399.9 mg/dL |
| | Hemoglobin | 200.0 mg/dL |
| | Potassium Thiocyanate | 66.9 mg/dL |
| | Salicylic Acid | 59.9 mg/dL |
| Whole Blood Potassium | Acetone | 69.7 mg/dL |
| | Acetylsalicylic Acid | 59.1 mg/dL |
| | Bilirubin Conjugate | 1000.0 mg/dL |
| | Bilirubin, Total | 10.0 mg/dL |
| | Cholesterol | 503.1 mg/dL |
| | Creatinine | 5.0 mg/dL |
| | Ethanol | 399.9 mg/dL |
| | Hemoglobin | 150.0 mg/dL |
| | Salicylic Acid | 15.0 mg/dL |
| | Sodium Bromide | 48.2 mg/dL |
| Whole Blood Chloride | Acetone | 69.7 mg/dL |
| | Acetylsalicylic Acid | 59.1 mg/dL |
| | Bilirubin Conjugate | 1000.0 mg/dL |
| | Bilirubin, Total | 20.0 mg/dL |
| | Cholesterol | 251.6 mg/dL |
| | Creatinine | 5.0 mg/dL |
| | Ethanol | 399.9 mg/dL |
| | Hemoglobin | 200.0 mg/dL |
| | Potassium Thiocyanate *8.4 mg/dL | |
| | Salicylic Acid | 45.0 mg/dL |
| | Sodium Bromide *24.1 mg/dL | |
| | Sodium Iodide | 11.3 mg/dL |

Interference Effect Summary Data

*Continued Interference

# Whole Blood Interference Observations

Bilirubin, Total showed interference with Potassium assay at concentrations 20 mg/dL, 15 mg/dL, with a bias greater than 0.22mmol/L.

Cholesterol showed interference with Chloride assay at concentrations 503 mg/dL, with a bias greater than 3.6mmol/L.

Hemoglobin showed interference with Potassium assay at concentrations 200 mg/dL, 377 mg/dL, 251 mg/dL with a bias greater than 0.27mmol/L.

{12}------------------------------------------------

# Whole Blood Interference Observations Continued

Potassium Thiocyanate showed interference with Chloride assay at all concentrations tested with a bias greater than 4.7mmol/L.

Salicylic Acid showed interference with Chloride assay at concentration 60 mg/dL with a bias greater than 8.5 and Potassium assay at concentrations 60 mg/dL, 29mg/dL, 22.5 mg/dL with a bias greater than 0.24mmol/L.

Sodium Bromide showed interference with Chloride assay at all concentrations tested with a bias greater than 22.1mmol/L and Potassium assay at concentrations 386 mg/dL, 93.5 mg/dL, 22.5 mg/dL with a bias greater than 0.32mmol/L.

Sodium lodide showed interference with Chloride assay at concentration 44.8mg/dL with a bias of 8.2mmol/L.

Avoid Hemolyzed samples for potassium. Hemolyzed samples may give incorrect elevated potassium.

# Reference Ranges

Concentration levels for each analyte represent medical decision levels as stated by Mosby's Diagnostic and Laboratory Test Reference 8ed. 2017 (See pages 260, 750, and 874 for additional information)

| Analyte | Reference Range (mmol/L) | |
|-----------|--------------------------|--|
| | Clinical Range | |
| Sodium | 136 - 145 | |
| Potassium | 3.5 - 5.0 | |
| Chloride | 98 - 106 | |

# Conclusions

Analysis of the comparative measurement presented in the 510(k) for this device, data collected for precision, linearity, and correlation demonstrates that the Selectalyte Analyzer (with Na *, K *, Cl ) is safe, effective and substantially equivalent to the predicate device to which it is compared.