Stat Profile Prime ES Comp Plus Analyzer System

K191365 · Nova Biomedical Corporation · JGS · Jul 19, 2019 · Clinical Chemistry

Device Facts

• Record ID: K191365
• Device Name: Stat Profile Prime ES Comp Plus Analyzer System
• Applicant: Nova Biomedical Corporation
• Product Code: JGS · Clinical Chemistry
• Decision Date: Jul 19, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1665
• Device Class: Class 2

Indications for Use

The Stat Profile Prime ES Comp Plus Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of sodium, potassium, and chloride in heparinized venous whole blood, plasma and serum. Sodium measurement is used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison’s disease, dehydration, or diseases involving electrolyte imbalance. Potassium measurement is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels. Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Device Story

Stat Profile Prime ES Comp Plus Analyzer is a microprocessor-based, benchtop blood electrolyte analyzer for clinical laboratory use. It accepts lithium heparinized whole blood, serum, or plasma samples (100 µL minimum) via syringes, open tubes, or small cups. The device utilizes ion-selective electrode (ISE) technology to measure Na+, K+, and Cl-. It features an onboard Quality Management System (QMS) for electronic monitoring and supports optional barcode scanning. Calibration and sampling are fully automated. The system detects installed sensor cards (Basic Electrolyte or Full Electrolyte) to configure test menus. Results are displayed on an integrated touch screen and printed via an onboard thermal printer. Healthcare professionals use the quantitative electrolyte data to diagnose and monitor metabolic and electrolyte disorders, directly informing clinical decisions regarding patient fluid and electrolyte management.

Clinical Evidence

Bench testing only. Precision/reproducibility evaluated per CLSI EP05-A3 (n=20 replicates, 20-day run-to-run). Linearity evaluated per CLSI EP06-A. Interference testing per CLSI EP07-A3. Method comparison study performed against predicate (K110648) using >150 whole blood and >100 serum/plasma samples per analyte; results showed high correlation (r² > 0.99) across claimed measuring ranges.

Technological Characteristics

Microprocessor-based analyzer using ion-selective electrode (ISE) technology for Na+, K+, and Cl- measurement. Features a 5.7" VGA color touch display, internal 1D/2D barcode scanner, and thermal printer. Uses a peristaltic pump with TPE (Pharmed BPT) tubing. Includes an analog front end with amperometric/potentiometric amplifiers, air detection, and temperature control. Operates on lithium heparinized samples. System is configured via interchangeable sensor cards.

Indications for Use

Indicated for use by healthcare professionals in clinical laboratory settings for quantitative determination of sodium, potassium, and chloride in heparinized venous whole blood, plasma, and serum. Used for diagnosis/treatment of electrolyte/metabolic disorders including aldosteronism, diabetes insipidus, adrenal hypertension, Addison’s disease, dehydration, 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.

Predicate Devices

• Nova Stat Profile pHOx Ultra Blood Gas Analyzer System (k110648)

Submission Summary (Full Text)

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Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY AND INSTRUMENT

## I Background Information:

A 510(k) Number
K191365

B Applicant
Nova Biomedical Corporation

C Proprietary and Established Names
Stat Profile Prime ES Comp Plus Analyzer System

D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JGS | Class II | 21 CFR 862.1665 - Sodium Test System | CH - Clinical Chemistry |
| CEM | Class II | 21 CFR 862.1600 - Potassium test system | CH - Clinical Chemistry |
| CGZ | Class II | 21 CFR 862.1170 - Chloride test system | CH - Clinical Chemistry |
| JJE | Class I | 21 CFR 862.2160 - Discrete photometric chemistry analyzer for clinical use | CH - Clinical Chemistry |

## II Submission/Device Overview:

A Purpose for Submission:
New Device

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B Measurand:
Sodium, Potassium and Chloride

C Type of Test:
Quantitative, potentiometric, ion selective electrode technology.

III Intended Use/Indications for Use:

A Intended Use(s):
See Indications for Use below.

B Indication(s) for Use:
The Stat Profile Prime ES Comp Plus Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of sodium, potassium, and chloride in heparinized venous whole blood, plasma and serum. Sodium measurement is used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison’s disease, dehydration, or diseases involving electrolyte imbalance.

Potassium measurement is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.

Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
Not for Point-of-care use

D Special Instrument Requirements:
Stat Profile Prime ES Comp Plus Analyzer System

IV Device/System Characteristics:

A Device Description:
The Stat Profile Prime ES Comp Plus Analyzer System is designed to be used in a clinical laboratory setting. The analyzer consists of, sensor cartridges, calibrator packs, ampuled quality control materials (external controls) and thermal paper for an onboard printer. Specimens are identified by scanning a barcode or by manually entering the information via the touchscreen.

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The Stat Profile Prime ES Comp Plus Analyzer has slots to accommodate two sensor cartridges (primary and auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed.

## B Principle of Operation:

The sodium, potassium, and chloride parameters are measured by an ion-selective electrode (ISE) that selectively measures the activity of ionic species. When the ISE comes in contact with a sample, a potential is developed. This potential is proportional to the logarithm of the ionic activity and is measured versus a reference electrode, as described by the Nernst equation.

## C Instrument Description Information:

| Modes of Operation | Yes | No |
| --- | --- | --- |
| Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? | ☑ | ☐ |
| Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? | ☑ | ☐ |
| Software | | |
| FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types. | ☑ | ☐ |

1. Instrument Name:

Stat Profile Prime ES Comp Plus Analyzer System

2. Specimen Identification:

Specimen may be identified by scanning a barcode or by manually entering the information via the touchscreen.

3. Specimen Sampling and Handling:

Lithium heparinized venous whole blood from syringes and open blood collection tubes or containers can be aspirated by positioning the sample over a probe. Plasma and serum samples from open containers can be sampled over a probe or using the tray mode.

4. Calibration:

The Analyzer has an automated calibrator which is used to perform a 2-point calibration 30 minutes after being powered on and regularly thereafter to maintain optimal Sensor Card and air detector performance. Then a 1-point calibration is performed at regular intervals to monitor the Sensor Card’s performance between each 2-point calibration.

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5. Quality Control:

The sponsor recommends that controls be assayed daily and/or after performing system maintenance. The frequency of controls should correspond to laboratory guidelines and follow federal, state and local guidelines.

V Substantial Equivalence Information:

A Predicate Device Name(s):

Nova Stat Profile pHOx Ultra Blood Gas Analyzer System

B Predicate 510(k) Number(s):

k110648

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K191365 | K110648 |
| --- | --- | --- |
| Device Trade Name | Stat Profile Prime ES Comp Plus Analyzer System | Nova Stat Profile pHOx Ultra Analyzer System |
| General Device Characteristic Similarities | | |
| Intended Use/Indications for Use | For the quantitative determination of sodium, potassium, and chloride, in heparinized venous whole blood, plasma and serum. | Same |
| Measuring range – Na | 80-200 mmol/L | Same |
| Measuring range – K | 1.0-20.0 mmol/L | Same |
| Measuring range – CL | 50-200 mmol/L | Same |
| Measuring Principle | Ion selective electrode | Same |
| General Device Characteristic Differences | | |
| Sample Volume | 100 μL | 60-210 μL dependent on selected test panel |
| Touch Screen | 5.7" VGA full color display with LED backlight and integrated touch panel | 12.1" LCD, 1024x768 pixel, Resistive Touch |
| Bar Code Scanner | Internal Integrated 1D/2D | External (optional) 1D |

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VI Standards/Guidance Documents Referenced:

- CLSI EP05-A3: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Third Edition.
- CSLI EP06-A Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline.
- CLSI EP07-A3 Interference Testing in Clinical Chemistry; Approved Guideline - Third Edition.
- CLSI EP17-A Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline.
- EP25-A: Evaluation of In Vitro Diagnostic Reagents; Approved Guideline.

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:

Within-Run Precision:

The study was performed following the CLSI EP05-A3 guideline. Within-Run and between-analyzer precision study were performed using two levels of quality control materials, whole blood, serum and lithium heparin plasma samples, on three Stat Profile Prime ES Comp Plus Analyzers. Each sample was tested in one run in replicates of 20 on each of the three analyzers. The results of one representative analyzer are summarized in the table below:

Within-run precision using External Quality samples:

| Parameter | n=20 | Control Level 1 | Control Level 2 |
| --- | --- | --- | --- |
| Sodium (mmol/L) | Mean | 147.5 | 118.9 |
| | SD | 0.2 | 0.5 |
| | %CV | 0.2 | 0.4 |
| Potassium (mmol/L) | Mean | 3.67 | 6.34 |
| | SD | 0.0 | 0.02 |
| | %CV | 0.1 | 0.3 |
| Chloride(mmol/L) | Mean | 107.0 | 86.4 |
| | SD | 0.3 | 0.5 |
| | %CV | 0.3 | 0.6 |

Within-run precision using whole blood samples:

| Sodium (mmol/L) (n=20) | | | |
| --- | --- | --- | --- |
| Sample | Mean | SD | %CV |
| Sample 1 | 120.7 | 0.1 | 0.1 |
| Sample 2 | 146.8 | 0.3 | 0.2 |
| Sample 3 | 169.1 | 0.3 | 0.2 |

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| Potassium (mmol/L) (n=20) | | | |
| --- | --- | --- | --- |
| Sample | Mean | SD | %CV |
| Sample 1 | 2.39 | 0.01 | 0.2 |
| Sample 2 | 4.07 | 0.02 | 0.6 |
| Sample 3 | 8.23 | 0.03 | 0.4 |
| Chloride (mmol/L) (n=20) | | | |
| --- | --- | --- | --- |
| Sample | Mean | SD | %CV |
| Sample 1 | 74.9 | 0.2 | 0.2 |
| Sample 2 | 106.5 | 0.2 | 0.2 |
| Sample 3 | 158.8 | 0.6 | 0.4 |

Within-run precision using lithium heparin plasma samples

| Sodium (mmol/L) (n=20) | | | |
| --- | --- | --- | --- |
| Sample | Mean | SD | %CV |
| Sample 1 | 122.7 | 0.2 | 0.2 |
| Sample 2 | 142.6 | 0.2 | 0.1 |
| Sample 3 | 160.8 | 0.1 | 0.1 |
| Potassium (mmol/L) (n=20) | | | |
| --- | --- | --- | --- |
| Sample | Mean | SD | %CV |
| Sample 1 | 2.65 | 0.01 | 0.5 |
| Sample 2 | 4.24 | 0.01 | 0.2 |
| Sample 3 | 6.62 | 0.00 | 0.1 |
| Chloride (mmol/L) (n=20) | | | |
| --- | --- | --- | --- |
| Sample | Mean | SD | %CV |
| Sample 1 | 75.7 | 0.4 | 0.5 |
| Sample 2 | 107.9 | 0.1 | 0.1 |
| Sample 3 | 151.1 | 0.1 | 0.1 |

Within-run precision using serum samples

| Sodium (mmol/L) (n=20) | | | |
| --- | --- | --- | --- |
| Sample | Mean | SD | %CV |
| Sample 1 | 120.1 | 0.2 | 0.2 |
| Sample 2 | 145.7 | 0.2 | 0.1 |
| Sample 3 | 164.8 | 0.5 | 0.3 |
| Potassium (mmol/L) (n=20) | | | |
| --- | --- | --- | --- |
| Sample | Mean | SD | %CV |
| Sample 1 | 2.44 | 0.02 | 0.8 |
| Sample 2 | 4.61 | 0.01 | 0.1 |
| Sample 3 | 6.86 | 0.05 | 0.8 |

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| Chloride (mmol/L) (n=20) | | | |
| --- | --- | --- | --- |
| Sample | Mean | SD | %CV |
| Sample 1 | 74.6 | 0.3 | 0.4 |
| Sample 2 | 110.4 | 0.2 | 0.2 |
| Sample 3 | 146.3 | 0.5 | 0.3 |

Run-to run precision:

Run-to-run precision was assessed by analyzing QC samples, each sample was tested in duplicate per run, 2 runs per day, using 3 analyzers over 20 days. The summary results for the three analyte test systems are shown below:

Run-to run precision using External QC samples:

| Sodium | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Sample | Pooled mean | N | Within run | | Total imprecision | |
| | | | SD | %CV | SD | %CV |
| QC level 1 | 146.9 | 240 | 0.4 | 0.3 | 0.7 | 0.5 |
| QC level 2 | 119.8 | 240 | 0.3 | 0.3 | 0.4 | 0.3 |
| Potassium | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Sample | Pooled mean | N | Within run | | Total imprecision | |
| | | | SD | %CV | SD | %CV |
| QC level 1 | 3.62 | 240 | 0.01 | 0.3 | 0.03 | 0.8 |
| QC level 2 | 6.27 | 240 | 0.01 | 0.2 | 0.03 | 0.5 |
| Chloride | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Sample | Pooled mean | N | Within run | | Total imprecision | |
| | | | SD | %CV | SD | %CV |
| QC level 1 | 106.3 | 240 | 0.4 | 0.4 | 0.6 | 0.6 |
| QC level 2 | 85.9 | 240 | 0.4 | 0.5 | 0.8 | 0.9 |

Run-to-run imprecision using whole blood, serum and plasma samples:

To assess run-to-run precision whole blood, lithium heparin plasma and serum samples, triplicate analysis was performed using each of the three sample matrices in ten separate runs on three analyzers for a total of 30 measurements. The systems were recalibrated before each triplicate run. Samples were analyzed on three analyzers. The results from one representative analyzer are summarized in the tables below:

Precision results for Sodium, Potassium and Chloride Matrix: whole blood:

| Parameter | N=30 | Sample 1 | Sample 2 | Sample 3 |
| --- | --- | --- | --- | --- |
| Sodium (mmol/L) | Mean | 122.0 | 144.7 | 162.9 |
| | SD | 0.3 | 0.2 | 0.3 |
| | %CV | 0.3 | 0.1 | 0.2 |
| Potassium (mmol/L) | Mean | 2.54 | 3.58 | 6.81 |
| | SD | 0.04 | 0.01 | 0.04 |
| | %CV | 1.5 | 0.4 | 0.6 |

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| Parameter | N=30 | Sample 1 | Sample 2 | Sample 3 |
| --- | --- | --- | --- | --- |
| Chloride (mmol/L) | Mean | 77.5 | 106.9 | 148.5 |
| | SD | 0.6 | 0.1 | 0.3 |
| | %CV | 0.8 | 0.1 | 0.2 |

Precision results for Sodium, Potassium and Chloride Matrix: Plasma

| Parameter | N=30 | Sample 1 | Sample 2 | Sample 3 |
| --- | --- | --- | --- | --- |
| Sodium (mmol/L) | Mean | 119.3 | 143.9 | 162.5 |
| | SD | 0.5 | 0.2 | 0.6 |
| | %CV | 0.4 | 0.2 | 0.4 |
| Potassium (mmol/L) | Mean | 2.63 | 4.03 | 6.43 |
| | SD | 0.02 | 0.01 | 0.04 |
| | %CV | 0.8 | 0.2 | 0.7 |
| Chloride (mmol/L) | Mean | 66.4 | 106.9 | 153.4 |
| | SD | 05 | 0.2 | 0.5 |
| | %CV | 0.7 | 0.2 | 0.3 |

Precision results for Sodium, Potassium and Chloride Matrix: Serum

| Parameter | N=30 | Sample 1 | Sample 2 | Sample 3 |
| --- | --- | --- | --- | --- |
| Sodium (mmol/L) | Mean | 119.5 | 140.5 | 162.3 |
| | SD | 0.4 | 0.4 | 0.3 |
| | %CV | 0.3 | 0.3 | 0.2 |
| Potassium (mmol/L) | Mean | 2.62 | 4.35 | 6.86 |
| | SD | 0.03 | 0.01 | 0.01 |
| | %CV | 1.2 | 0.3 | 0.2 |
| Chloride (mmol/L) | Mean | 64.4 | 105.0 | 158.0 |
| | SD | 0.5 | 0.3 | 0.5 |
| | %CV | 0.8 | 0.3 | 0.3 |

2. Linearity:

The linearity studies were performed following the CLSI EP6-A guideline. The studies were performed on three analyzers using lithium heparinized venous whole blood, plasma and serum. Low and high concentration pools were mixed and serial dilution samples (N=10 or 11) were prepared and tested in triplicate. The results from each candidate analyzer for each parameter were compared to expected values. All three analyzers yielded similar results. The results of the least squares linear regression analysis from one representative analyzer are summarized below:

Lithium heparin whole blood:

| Analyte | Claimed Measuring Range (mmol/L) | Sample Range Tested (mmol/L) | Slope | Intercept | r |
| --- | --- | --- | --- | --- | --- |
| Sodium | 80 - 200 | 73.4 - 213.9 | 0.9975 | 0.8170 | 0.9998 |
| Potassium | 1.0 - 20.0 | 0.86 - 24.08 | 1.0079 | -0.0642 | 0.9997 |
| Chloride | 50 - 200 | 48.8 - 203.7 | 1.0027 | -0.7042 | 0.9999 |

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Lithium heparin plasma:

| Analyte | Claimed Measuring Range (mmol/L) | Sample Range Tested (mmol/L) | Slope | Intercept | r |
| --- | --- | --- | --- | --- | --- |
| Sodium | 80 - 200 | 73.9 - 207.3 | 1.0118 | -1.6007 | 0.9999 |
| Potassium | 1.0 - 20.0 | 0.95 - 22.23 | 1.0064 | -0.1220 | 0.9999 |
| Chloride | 50 - 200 | 45.9 - 206.9 | 1.0018 | 0.0538 | 0.9999 |

Serum:

| Analyte | Claimed Measuring Range (mmol/L) | Sample Range Tested (mmol/L) | Slope | Intercept | r |
| --- | --- | --- | --- | --- | --- |
| Sodium | 80 - 200 | 78.6 - 207.8 | 0.9914 | 0.3424 | 0.9998 |
| Potassium | 1.0 - 20.0 | 0.92 - 21.03 | 0.9930 | -0.0625 | 0.9989 |
| Chloride | 50 - 200 | 49.5 - 202.7 | 0.9809 | 1.6611 | 0.9999 |

The linear regression results support the claimed measuring ranges, as summarized in the tables above.

3. Analytical Specificity/Interference:

Interference studies were performed according to CLSI EP07-A3 guideline. The sponsor collected serum sample and plasma from donors. Samples were divided to create two separate pools one for control and the other for test samples. The potential interferents were tested at two analyte concentrations. If interference was identified, then a dose response was performed to determine the lowest concentration where the interfering substance may alter the results. For all analytes, the sponsor defined interference as $ > \pm 10\% $ bias from the test results when compared to the control sample. The sponsor determined the following substances did not cause interference at the concentrations listed below:

Sodium:

| Interferent | Highest concentration tested that did not cause significant interference |
| --- | --- |
| Acetoacetate | 2 mmol/L |
| Acetylsalicylic Acid | 3.62 mmol/L |
| Ammonium Chloride | 107μmol/L |
| Ascorbic Acid | 50 mg/dL |
| Benzalkonium Chloride | 10 mg/dL |
| Bilirubin (Conjugate) | 342 μmol/L |
| Calcium Chloride | 2 mmol/L |
| Dobutamine | 2 mg/dL |
| Hemoglobin | 2 g/dL |
| Ibuprofen | 2.4 mmol/L |
| Intralipid | 4000 mg/dL |
| Lithium Lactate | 6.6 mmol/L |
| Magnesium Chloride | 15 mmol/L |
| Potassium Chloride | 5 mmol/L |
| Salicylic Acid | 4.34 mmol/L |

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| Interferent | Highest concentration tested that did not cause significant interference |
| --- | --- |
| Sodium Thiocyanate | 6.8 mmol/L |
| Zinc Chloride | 1.3 mg/L |

Potassium:

| Interferent | Highest concentration tested that did not cause significant interference |
| --- | --- |
| Acetoacetate | 2 mmol/L |
| Acetylsalicylic Acid | 3.62 mmol/L |
| Ammonium Chloride | 107μmol/L |
| Ascorbic Acid | 50 mg/dL |
| Benzalkonium Chloride | 10 mg/dL |
| Bilirubin (Conjugate) | 342 μmol/L |
| Calcium Chloride | 2 mmol/L |
| Dobutamine | 2 mg/dL |
| Hemoglobin | 2 g/dL |
| Ibuprofen | 2.4 mmol/L |
| Intralipid | 4000 mg/dL |
| Lithium Lactate | 6.6 mmol/L |
| Magnesium Chloride | 15 mmol/L |
| Salicylic Acid | 4.34 mmol/L |
| Sodium Bromide | 37.5 mmol/L |
| Sodium Chloride | 10 mmol/L |
| Sodium Citrate | 12 mmol/L |
| Sodium Iodide | 2.99 mmol/L |
| Sodium Oxalate | 500 mg/dL |
| Sodium Perchlorate | 1 mmol/L |
| Sodium Thiocyanate | 6.8 mmol/L |
| Zinc Chloride | 1.3 mg/dL |

Chloride:

| Interferent | Highest concentration tested that did not cause significant interference |
| --- | --- |
| Acetoacetate | 2 mmol/L |
| Acetylsalicylic Acid | 3.62 mmol/L |
| Ammonium Chloride | 107μmol/L |
| Ascorbic Acid | 50 mg/dL |
| Benzalkonium Chloride | 10 mg/dL |
| Bilirubin (Conjugate) | 342 μmol/L |
| Dobutamine | 2 mg/dL |
| Hemoglobin | 2 g/dL |
| Ibuprofen | 2.4 mmol/L |
| Intralipid | 4000 mg/dL |
| Lithium Lactate | 6.6 mmol/L |
| Salicylic Acid | 4.34 mmol/L |
| Sodium Citrate | 12 mmol/L |

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| Interferent | Highest concentration tested that did not cause significant interference |
| --- | --- |
| Sodium Oxalate | 500 mg/dL |
| Sodium Perchlorate | 1 mmol/L |

The sponsor has listed the following interfering substances as causing clinically significant effects on test results in whole blood, serum and plasma samples in the labeling:

| Parameter | Interferent | Interferent Observed at Concentrations Above: |
| --- | --- | --- |
| Chloride | Sodium Bromide | 2.3 mmol/L |
| | Sodium Iodide | 1.5 mmol/L |
| | Sodium Thiocyanate | 1.7 mmol/L |

4. Assay Reportable Range:

Reportable ranges for venous whole blood, plasma and serum:

| Analyte | Claimed Measuring Range (mmol/L) |
| --- | --- |
| Sodium | 80 - 200 |
| Potassium | 1.0 - 20.0 |
| Chloride | 50 - 200 |

5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

The sodium and chloride standards and reagents are traceable to NIST SRM 919a. The potassium standards and reagents are traceable to NIST SRM 918a.

6. Detection Limit:

The performance at the lower end of the measuring range for sodium, potassium, and chloride is supported by the linearity studies (see section VII.A.2 above).

7. Assay Cut-Off:

Not applicable.

8. Accuracy (Instrument):

Not applicable.

9. Carry-Over:

No applicable

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B Comparison Studies:

1. Method Comparison with Predicate Device:

A method comparison study was performed by testing a minimum of one hundred and fifty lithium heparin whole blood samples and a minimum of one hundred samples for serum and lithium heparin plasma on one Stat Profile Prime ES Comp Plus Analyzer (candidate device) and two Stat Profile pHOx Ultra Analyzers (predicate device) for each parameter. In order to cover the extreme ends of the claimed measuring range a limited number of specimens were spiked or diluted. The singlet result from each test analyzer was compared to the average of the results from the comparative method.

The linear regression analyses for the three electrolytes are summarized below:

Lithium heparin whole blood:

| Analyte | Slope | Intercept | r² | N | Range tested (mmol/L) |
| --- | --- | --- | --- | --- | --- |
| Sodium | 1.0093 | -1.2315 | 0.9951 | 191 | 80.2-199.7 |
| Potassium | 0.9988 | 0.0240 | 0.9995 | 189 | 1.70-18.78 |
| Chloride | 1.0056 | 0.4426 | 0.9958 | 191 | 59.1-193.2 |

Lithium heparin plasma:

| Analyte | Slope | Intercept | r² | N | Range tested (mmol/L) |
| --- | --- | --- | --- | --- | --- |
| Sodium | 0.9931 | 1.5744 | 0.9982 | 122 | 83.7-192.0 |
| Potassium | 1.0057 | 0.0177 | 0.9997 | 121 | 1.24-19.53 |
| Chloride | 1.0034 | 1.4280 | 0.9977 | 121 | 55.6-193.6 |

Serum:

| Analyte | Slope | Intercept | r² | N | Range tested (mmol/L) |
| --- | --- | --- | --- | --- | --- |
| Sodium | 1.0029 | -0.4950 | 0.9979 | 115 | 84.4-194.8 |
| Potassium | 1.0090 | -0.0050 | 0.9999 | 115 | 1.01-19.19 |
| Chloride | 1.0065 | 0.2906 | 0.9989 | 115 | 56.4 – 190.6 |

2. Matrix Comparison:

Not applicable. The performance of each test system with lithium heparin venous whole blood, lithium heparin plasma and serum was evaluated per the studies described in sections VII.A 1 to 5 and VII.B.1. Please see the performance studies above.

C Clinical Studies:

1. Clinical Sensitivity:

Not applicable.

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2. Clinical Specificity:

Not applicable.

3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):

Not applicable.

D Clinical Cut-Off:

Not applicable.

E Expected Values/Reference Range:

Reference range for sodium, potassium and chloride are cited from literature:
Sodium: 136-146 mmol/L
Potassium: 3.5-5.1 mmol/L
Chloride: 98-106 mmol/L

Reference:
Burtis, Carl A. and Ashwood, Edward R., ed. 1994. Tietz Textbook of Clinical
Chemistry. Philadelphia, PA: W. B. Saunders Co.

F Other Supportive Instrument Performance Characteristics Data:

Not applicable.

VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

IX Conclusion:

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

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