i-STAT CHEM8+ cartridge with the i-STAT 1 System

K183688 · Abbott Point of Care, Inc. · JGS · Feb 7, 2020 · Clinical Chemistry

Device Facts

• Record ID: K183688
• Device Name: i-STAT CHEM8+ cartridge with the i-STAT 1 System
• Applicant: Abbott Point of Care, Inc.
• Product Code: JGS · Clinical Chemistry
• Decision Date: Feb 7, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1665
• Device Class: Class 2

Intended Use

The i-STAT CHEM8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of sodium, potassium, chloride and blood urea nitrogen in arterial or venous whole blood in point of care or clinical laboratory settings. Sodium measurements are used for monitoring electrolyte imbalances. Potassium measurements are used in the diagnosis and monitoring of diseases and clinical conditions that manifest high and low potassium levels. Chloride measurements are primarily used in the diagnosis, monitoring, and treatment of electrolyte and metabolic disorders including, but not limited to, cystic fibrosis, diabetic acidosis, and hydration disorders. Blood urea nitrogen measurements are used for the diagnosis, monitoring, and treatment of certain renal and metabolic diseases.

Device Story

i-STAT CHEM8+ cartridge is a single-use, disposable, microfabricated silicon chip-based sensor system used with the i-STAT 1 handheld analyzer. It processes 65 μL of arterial or venous whole blood. The system utilizes ion-selective electrodes (potentiometric method) to measure potential differences between the sample and a calibrant solution. The analyzer calculates analyte concentrations using the Nernst equation. Designed for use by trained medical professionals in point-of-care or clinical laboratory settings. The device provides quantitative results for sodium, potassium, chloride, and BUN, enabling rapid assessment of electrolyte imbalances and renal function to support clinical decision-making.

Clinical Evidence

Bench testing only. Precision studies (internal and point-of-care) evaluated repeatability and reproducibility across multiple sites and analyzers. Linearity was confirmed using polynomial regression. Interference studies identified specific concentration limits for substances like lithium bromide, sodium thiosulfate, and triglycerides. Method comparison studies against the predicate device (N=177-188) showed strong correlation (r=0.92-0.99) across the reportable ranges.

Technological Characteristics

Microfabricated thin-film ion-selective electrodes on a silicon chip. Potentiometric sensing principle. Handheld analyzer with disposable cartridge containing fluid channels, pouch, and waste chamber. Traceable to NIST SRM 956 (Na, K, Cl) and NIST SRM 909 (BUN).

Indications for Use

Indicated for in vitro quantification of sodium, potassium, chloride, and blood urea nitrogen in arterial or venous whole blood for patients requiring electrolyte or renal function monitoring in point-of-care or clinical laboratory settings.

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

• SYNCHRON Systems Sodium Reagent on UniCel DxC 600/800 SYNCHRON Clinical System (K042291)
• SYNCHRON Systems Potassium Reagent on UniCel DxC 600/800 SYNCHRON Clinical System (K042291)
• SYNCHRON Systems Chloride Reagent on UniCel DxC 600/800 SYNCHRON Clinical System (K042291)
• SYNCHRON Systems BUN Reagent on UniCel DxC 600/800 SYNCHRON Clinical System (K042291)

Submission Summary (Full Text)

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

February 7, 2020

Abbott Point of Care Inc. Susan Tibedo Director, Regulatory Affairs 400 College Road East Princeton, NJ 08540

Re: K183688

Trade/Device Name: i-STAT CHEM8+ cartridge with the i-STAT 1 System Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium Test System Regulatory Class: Class II Product Code: JGS, CDS, CEM, CGZ Dated: January 9, 2020 Received: January 10, 2020

Dear Susan Tibedo:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Kellie Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K183688

Device Name

i-STAT CHEM8+ cartridge with the i-STAT 1 System

#### Indications for Use (Describe)

The i-STAT CHEM8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of sodium, potassium, chloride and blood urea nitrogen in arterial or venous whole blood in point of care or clinical laboratory settings.

Sodium measurements are used for monitoring electrolyte imbalances.

Potassium measurements are used in the diagnosis and monitoring of diseases and clinical conditions that manifest high and low potassium levels.

Chloride measurements are primarily used in the diagnosis, monitoring, and treatment of electrolyte and metabolic disorders including, but not limited to, cystic fibrosis, diabetic acidosis, and hydration disorders.

Blood urea nitrogen measurements are used for the diagnosis, monitoring, and treatment of certain renal and metabolic diseases.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary

The information in this 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

| 1. Submitter Information | |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Owner | Abbott Point of Care Inc.<br>400 College Road East<br>Princeton, NJ 08540 |
| Contact | Primary: Susan Tibedo<br>Director Regulatory Affairs<br>[e-mail]<br>Phone: [phone]<br><br>Secondary: Maria Figueroa<br>Manager Regulatory Affairs<br>[e-mail]<br>Phone: [phone] |
| Date Prepared | February 5, 2020 |
| 510(k) Number | k183688 |

# 2. Device Information

| Proprietary Name | i-STAT CHEM8+ cartridge with i-STAT 1 System |
|------------------|----------------------------------------------|
| Common Name | Chemistry test, analyzer, handheld |

| Product<br>code | Device Classification<br>name | Regulation<br>Number | Class | Panel |
|-----------------|-------------------------------------------|----------------------|-------|--------------------|
| JGS | Electrode, Ion Specific,<br>Sodium | 862.1665 | II | Clinical Chemistry |
| CEM | Electrode, Ion Specific,<br>Potassium | 862.1600 | II | Clinical Chemistry |
| CGZ | Electrode, Ion Specific<br>Chloride | 862.1170 | II | Clinical Chemistry |
| CDS | Electrode, Ion Specific,<br>Urea Nitrogen | 862.1770 | II | Clinical Chemistry |

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# 3. Predicate Device

Proprietary Name SYNCHRON Systems Sodium Reagent on UniCel DxC 600/800 SYNCHRON Clinical System

> SYNCHRON Systems Potassium Reagent on UniCel DxC 600/800 SYNCHRON Clinical System

SYNCHRON Systems Chloride Reagent on UniCel DxC 600/800 SYNCHRON Clinical System

SYNCHRON Systems BUN Reagent on UniCel DxC 600/800 SYNCHRON Clinical System

#### 510(k) Number K042291

| Product<br>code | Device Classification<br>name | Regulation<br>Number | Class | Panel |
|-----------------|---------------------------------------|----------------------|-------|--------------------|
| JGS | Electrode, Ion Specific,<br>Sodium | 862.1665 | II | Clinical Chemistry |
| CEM | Electrode, Ion Specific,<br>Potassium | 862.1600 | II | Clinical Chemistry |
| CGZ | Electrode, Ion Specific<br>Chloride | 862.1170 | II | Clinical Chemistry |
| LFP | Conductivity Rate, Urea<br>Nitrogen | 862.1770 | II | Clinical Chemistry |

# 4. Device Description

The i-STAT CHEM8+ test cartridge contains test reagents to analyze whole blood at the point of care or in the clinical laboratory for sodium, potassium, chloride and blood urea nitrogen. The test is contained in a single-use, disposable cartridges require two to three drops of whole blood which are typically applied to the cartridge using a transfer device.

The i-STAT 1 Analyzer is a handheld, in vitro diagnostic analytical device designed to run only i-STAT test cartridges. The instrument interacts with the cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes).

The i-STAT 1 System is comprised of the i-STAT 1 analyzer, the i-STAT test cartridges and accessories (i-STAT 1 Downloader/Recharger, electronic simulator and portable printer). The system is designed for use by trained medical professionals at the patient point of care or in the clinical laboratory and is for prescription use only.

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# 5. Intended Use Statement

The i-STAT CHEM8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of sodium, potassium, chloride and blood urea nitrogen in arterial or venous whole blood in point of care or clinical laboratory settings.

Sodium measurements are used for monitoring electrolyte imbalances.

Potassium measurements are used in the diagnosis and monitoring of diseases and clinical conditions that manifest high and low potassium levels.

Chloride measurements are primarily used in the diagnosis, monitoring, and treatment of electrolyte and metabolic disorders including, but not limited to, cystic fibrosis, diabetic acidosis, and hydration disorders.

Blood urea nitrogen measurements are used for the diagnosis, monitoring, and treatment of certain renal and metabolic diseases.

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| Similarities and Differences: System (Test and Instrument) for Sodium | | |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature or<br>Characteristic | Predicate<br>SYNCHRON Systems Sodium<br>Reagent on UniCel DxC 600/800<br>SYNCHRON Clinical System<br>(K042291) | Candidate<br>Sodium Test with i-STAT 1<br>System |
| Intended Use | The sodium test systems are intended<br>for the quantitative determination of<br>sodium concentration in human<br>serum, plasma or urine.<br><br>Sodium measurements are used in the<br>diagnosis and treatment of<br>aldosteronism (excessive secretion of<br>hormone aldosterone), diabetes<br>insipidus, adrenal hypertension,<br>Addison's disease, dehydration,<br>inappropriate antidiuretic hormone<br>secretion, or other diseases involving<br>electrolyte imbalance. | The i-STAT CHEM8+ cartridge with<br>the i-STAT 1 System is intended for<br>use in the <i>in vitro</i> quantification of<br>sodium, potassium, chloride and blood<br>urea nitrogen in arterial or venous<br>whole blood in point of care or clinical<br>laboratory settings.<br><br>Sodium measurements are used for<br>monitoring electrolyte imbalances. |
| Reportable Range | 100-200 mmol/L (Serum or Plasma)<br>10-300 mmol/L (Urine) | Sodium: 100-180 mmol/L (mEq/L) |
| Sample Type | Serum, plasma, urine | Arterial or venous whole blood |
| Sample Volume | 0.5 mL (500 $ μ $ L) | 95 $ μ $ L |
| Preparation | Sample tubes prepared and then<br>processed within analyzer | Ready to Use |
| Traceability<br>Calibration | NIST SRM 919<br>Must be conducted every 24 hours and<br>with each new reagent | NIST SRM 956<br>1-point on-board contained within the<br>cartridge |
| Time to Test<br>(Sample Stability) | Serum or plasma: Within 8 hours at<br>room temperature, or up to 48 hours if<br>stored at +2°C to +8°C<br><br>Urine: Within 2 hours of collection | Heparinized samples: within 30<br>minutes of collection |
| Principle of<br>Measurement | Ion selective electrode | Ion selective electrode |
| Reagent Format | Reagent handling system, stored<br>within analyzer | Cartridge |
| Reagent Storage<br>and Stability | Room temperature | 2°C to 8°C (35-46°F) |
| Similarities and Differences: System (Test and Instrument) for Potassium | | |
| Feature or<br>Characteristic | Predicate<br>SYNCHRON Systems Potassium<br>Reagent on UniCel DxC 600/800<br>SYNCHRON Clinical System<br>(K042291) | Candidate<br>Potassium Test with i-STAT 1<br>System |
| Intended Use | The potassium test systems are<br>intended the quantitative<br>determination of potassium<br>concentration in human serum, plasma<br>or urine.<br><br>Potassium measurements are used in<br>the diagnosis and treatment of<br>hypokalemia (metabolic alkalosis,<br>metabolic acidosis or the absence of<br>acid-base disturbances), hyperkalemia<br>(over administration of potassium,<br>acidosis, or crush injuries), renal<br>failure, Addison's disease or other<br>diseases involving electrolyte<br>imbalance. | The i-STAT CHEM8+ cartridge with<br>the i-STAT 1 System is intended for<br>use in the <i>in vitro</i> quantification of<br>sodium, potassium, chloride and blood<br>urea nitrogen in arterial or venous<br>whole blood in point of care or clinical<br>laboratory settings<br><br>Potassium measurements are used in<br>the diagnosis and monitoring of<br>diseases and clinical conditions that<br>manifest high and low potassium<br>levels. |
| Reportable Range | 1-15.0 mmol/L (Serum or Plasma) | 2.0 - 9.0 mmol/L (mEq/L) |
| Sample Type | Serum, plasma, urine | Arterial or venous whole blood |
| Sample Volume | 0.5 mL (500 µL) | 95 µL |
| Sample<br>Preparation | Sample tubes prepared and then<br>processed within analyzer | Ready to Use |
| Traceability | NIST SRM 918 | NIST SRM 956 |
| Calibration | Must be conducted every 24 hours and<br>with each new reagent | 1-point on-board contained within the<br>cartridge |
| Time to Test<br>(Sample Stability) | Serum or plasma: Within 8 hours at<br>room temperature, or up to 48 hours if<br>stored at +2°C to +8°C<br><br>Urine: Within 2 hours of collection | Non-anticoagulated samples: within 3<br>minutes of collection<br><br>Heparinized samples: within 30<br>minutes of collection |
| Principle of<br>Measurement | Ion selective electrode | Ion selective electrode |
| Reagent Format | Reagent handling system, stored<br>within analyzer | Cartridge |
| Reagent Storage<br>and Stability | Room temperature | 2°C to 8°C (35-46°F) |
| Analyzer Type | Floor Model | Handheld |
| Similarities and Differences: System (Test and Instrument) for Chloride | | |
| Feature or<br>Characteristic | Predicate<br>SYNCHRON Systems Chloride<br>Reagent on UniCel DxC 600/800<br>SYNCHRON Clinical System<br>(K042291) | Candidate<br>Chloride Test with i-STAT 1<br>System |
| Intended Use | The chloride test systems are intended<br>for the quantitative determination of<br>chloride concentration in human serum,<br>plasma, urine or cerebrospinal fluid<br>(CSF).<br>Chloride measurements are used in the<br>diagnosis and treatment of electrolyte<br>and metabolic disorders such as cystic<br>fibrosis and diabetic acidosis. | The i-STAT CHEM8+ cartridge<br>with the i-STAT 1 System is<br>intended for use in the in vitro<br>quantification of sodium, potassium,<br>chloride and blood urea nitrogen in<br>arterial or venous whole blood in<br>point of care or clinical laboratory<br>settings.<br>Chloride measurements are primarily<br>used in the diagnosis, monitoring,<br>and treatment of electrolyte and<br>metabolic disorders including, but<br>not limited to, cystic fibrosis,<br>diabetic acidosis, and hydration<br>disorders. |
| Reportable Range | 50-200 mmol/L (Serum or Plasma) | 65-140 mmol/L (mEq/L) |
| Sample Type | Serum, plasma, urine | Arterial or, venous whole blood |
| Sample Volume | 0.5 mL (500 µL) | 95 µL |
| Sample | Sample tubes prepared and then | Ready to Use |
| Preparation | processed within analyzer | |
| Traceability | NIST SRM 918/919 | NIST SRM 956 |
| Calibration | Must be conducted every 24 hours and<br>with each new reagent | 1-point on-board contained within<br>the cartridge |
| Time to Test<br>(Sample Stability) | Serum or plasma: Within 8 hours at<br>room temperature, or up to 48 hours if<br>stored at +2°C to +8°C<br>Urine: Within 2 hours of collection | Non-anticoagulated samples: within<br>3 minutes of collection<br>Heparinized samples: within 30<br>minutes of collection |
| Principle of<br>Measurement | Ion selective electrode | Ion selective electrode |
| Reagent Format | Reagent handling system, stored within<br>analyzer | Cartridge |
| Reagent Storage<br>and Stability | Room temperature | 2°C to 8°C (35-46°F) |
| Analyzer Type | Floor Model | Handheld |
| Feature or<br>Characteristic | Predicate<br>SYNCHRON Systems BUN<br>Reagent on UniCel DxC 600/800<br>SYNCHRON Clinical System<br>(K042291) | Candidate<br>BUN Test with i-STAT 1<br>System |
| Intended Use | The blood urea nitrogen (BUN) test<br>systems are intended for the<br>quantitative determination of urea<br>nitrogen or urea concentration in<br>human serum, plasma or urine.<br><br>Urea nitrogen or urea measurements are<br>used in the diagnosis and treatment of<br>certain renal and metabolic diseases. | The i-STAT CHEM8+ cartridge with<br>the i-STAT 1 System is intended for<br>use in the in vitro quantification of<br>sodium, potassium, chloride and<br>blood urea nitrogen in arterial or<br>venous whole blood in point of care<br>or clinical laboratory settings<br><br>Blood urea nitrogen measurements<br>are used for the diagnosis,<br>monitoring, and treatment of certain<br>renal and metabolic diseases. |
| Reportable Range | 1-150 mg/dL (Serum or Plasma)<br>10-1500 mg/dL (Urine) | 3-140 mg/dL |
| Sample Type | Serum, plasma, urine | Arterial or venous whole blood |
| Sample Volume | 0.5 mL (500 μL) | 95 µL |
| Sample Preparation | Sample tubes prepared and then<br>processed within analyzer | Ready to Use |
| Traceability | NIST SRM 912 | NIST SRM 909 |
| Calibration | Must be conducted every 24 hours and<br>with each new reagent | 1-point on-board contained within<br>the cartridge |
| Time to Test<br>(Sample Stability) | Serum or plasma: Within 8 hours at<br>room temperature, or up to 48 hours at<br>+2°C to +8°C<br>Urine: Within 2 hours of collection | Non-anticoagulated samples: within<br>3 minutes of collection<br>Heparinized samples: within 30<br>minutes of collection |
| Principle of<br>Measurement | Conductivity | Ion selective electrode |
| Reagent Format | Reagent handling system, stored within<br>analyzer | Cartridge |
| Reagent Storage<br>and Stability | 2°C to 8°C (35-46°F) | 2°C to 8°C (35-46°F) |
| Analyzer Type | Floor Model | Handheld |

- 6. Summary Comparison of Technological Characteristics

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# 7. Performance Characteristics

# Analytical Performance

- a. Precision
# Precision 20 days (Aqueous Materials)

The precision of the i-STAT Potassium, Chloride, and BUN Tests on the i-STAT 1 Analyzer were evaluated using 5 levels of aqueous materials. This 20-day multi-day precision testing was based on CLSI document EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline-Third Edition. The study

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was conducted using multiple instruments and one test cartridge lot over 20 days at one site. Total precision ('within-laboratory', Sr), within-run, (Sr), between-run, (Sm) and between-day, (Saa) were estimated for each level. The results of the 20-day precision study are shown in Table 1.

| Table 1: 20-day Precision Study Results (i-STAT 1 Analyzer) | | | | | | | | | | | | |
|-------------------------------------------------------------|----------------|----|-------|-------|-------|------------|------------|------------|-------------|-------------|-------------|-------------|
| i-STAT<br>Test | Fluid<br>Level | N | Mean | ST | Total | | Within-run | | Between-run | | Between-day | |
| | | | | | | CVT<br>(%) | Sr | CVr<br>(%) | Srr | CVrr<br>(%) | Sdd | CVdd<br>(%) |
| Sodium<br>(mmol/L) | CV L1 | 81 | 100.0 | 0.27 | 0.3 | 0.25 | 0.3 | 0.07 | 0.1 | 0.07 | 0.1 | |
| | CV L2 | 81 | 121.6 | 0.35 | 0.3 | 0.33 | 0.3 | 0.09 | 0.1 | 0.10 | 0.1 | |
| | CV L3 | 81 | 134.8 | 0.31 | 0.2 | 0.28 | 0.2 | 0.09 | 0.1 | 0.10 | 0.1 | |
| | CV L4 | 80 | 160.4 | 0.41 | 0.3 | 0.39 | 0.2 | 0.10 | 0.1 | 0.10 | 0.1 | |
| | CV L5 | 80 | 178 | 0.42 | 0.2 | 0.40 | 0.2 | 0.10 | 0.1 | 0.11 | 0.1 | |
| Potassium<br>(mmol/L) | CV L1 | 81 | 2.07 | 0.006 | 0.3 | 0.006 | 0.3 | 0.001 | 0.05 | 0.002 | 0.1 | |
| | CV L2 | 81 | 2.83 | 0.011 | 0.4 | 0.011 | 0.4 | 0.003 | 0.1 | 0.002 | 0.1 | |
| | CV L3 | 81 | 3.69 | 0.010 | 0.3 | 0.008 | 0.2 | 0.004 | 0.1 | 0.003 | 0.1 | |
| | CV L4 | 80 | 6.17 | 0.018 | 0.3 | 0.017 | 0.3 | 0.002 | 0.03 | 0.007 | 0.1 | |
| | CV L5 | 80 | 7.75 | 0.033 | 0.4 | 0.027 | 0.3 | 0.017 | 0.2 | 0.009 | 0.1 | |
| Chloride<br>(mmol/L) | CV L1 | 81 | 70.9 | 0.47 | 0.7 | 0.43 | 0.6 | 0.12 | 0.2 | 0.12 | 0.2 | |
| | CV L2 | 81 | 76.2 | 0.53 | 0.7 | 0.50 | 0.7 | 0.13 | 0.2 | 0.13 | 0.2 | |
| | CV L3 | 81 | 89.2 | 0.33 | 0.4 | 0.29 | 0.3 | 0.08 | 0.1 | 0.12 | 0.1 | |
| | CV L4 | 80 | 107.9 | 0.43 | 0.4 | 0.40 | 0.4 | 0.11 | 0.1 | 0.12 | 0.1 | |
| | CV L5 | 80 | 122.3 | 0.48 | 0.4 | 0.44 | 0.4 | 0.15 | 0.1 | 0.12 | 0.1 | |
| BUN<br>(mg/dL) | CV L1 | 81 | 107.3 | 0.91 | 0.8 | 0.81 | 0.8 | 0.41 | 0.4 | 0.04 | 0.04 | |
| | CV L2 | 81 | 59.7 | 0.92 | 1.5 | 0.86 | 1.4 | 0.23 | 0.4 | 0.20 | 0.3 | |
| | CV L3 | 81 | 10.5 | 0.12 | 1.1 | 0.11 | 1.0 | 0.05 | 0.5 | 0.03 | 0.3 | |
| | CV L4 | 80 | 8.1 | 0.18 | 2.2 | 0.17 | 2.1 | 0.03 | 0.4 | 0.05 | 0.6 | |
| | CV L5 | 80 | 4.1 | 0.15 | 3.7 | 0.14 | 3.4 | 0.04 | 1.0 | 0.03 | 0.7 | |

# Precision (Whole Blood)

The whole blood precision of the i-STAT Sodium, Potassium, Chloride, and BUN Tests on i-STAT 1 Analyzer were evaluated using venous whole blood (native or altered) samples targeted to three levels within the test reportable range.

One test cartridge lot was used across 3 point of care sites. At each site, each sample was tested 3 times on each of 7 i-STAT 1 Analyzers (total of 21 test results per sample per instrument). The results of the whole blood precision using the i-STAT 1 Analyzer are shown in Table 2.

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| Table 2: Whole Blood Precision Results - i-STAT 1 Wireless Analyzer | | | | | | | | | | |
|---------------------------------------------------------------------|------------------|------|----|-------|-----------------|-----|-------|----------------|-----|-------------|
| i-STAT<br>Test | Level | Site | N | Mean | Within-Analyzer | | | Total | | |
| | | | | | SD | %CV | SD | SD 95% CI | %CV | %CV 95% CI |
| | ≤ 13…