i-STAT CG8+ cartridge with the i-STAT 1 System

K230285 · Abbott Point of Care, Inc. · CHL · Oct 27, 2023 · Clinical Chemistry

Device Facts

• Record ID: K230285
• Device Name: i-STAT CG8+ cartridge with the i-STAT 1 System
• Applicant: Abbott Point of Care, Inc.
• Product Code: CHL · Clinical Chemistry
• Decision Date: Oct 27, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Intended Use

The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of pH, partial pressure of oxygen (PO2), and partial pressure of carbon dioxide (PCO2), in arterial, venous, or capillary whole blood in point of care or clinical laboratory settings. pH, PO2, and PCO2 measurements are used in the diagnosis, monitoring, and treatment of respiratory, metabolic and acid-base disturbances.

Device Story

i-STAT CG8+ cartridge is a single-use, disposable, point-of-care diagnostic component used with the i-STAT 1 analyzer. It accepts 95μL of whole blood (arterial, venous, or capillary) into a sample well. The cartridge contains integrated sensors, fluid channels, and a calibrant pouch. pH and pCO2 are measured via direct potentiometry; pO2 is measured amperometrically using a Clark-type electrode. The analyzer performs all fluid movement and analysis internally. Results are displayed on the i-STAT 1 analyzer for clinician review. These measurements assist in diagnosing and monitoring respiratory, metabolic, and acid-base disturbances, enabling rapid clinical decision-making at the point of care.

Clinical Evidence

No clinical trials were required. Analytical performance was established via bench testing. Precision was evaluated using aqueous controls and whole blood (arterial, venous, capillary) across multiple sites. Linearity was confirmed across the reportable range (pH 6.5-7.8; pO2 10-700 mmHg; pCO2 5-130 mmHg). Method comparison against a comparative method (N=468) showed high correlation (r=0.97-0.99). Interference testing confirmed no significant impact from common substances (e.g., acetaminophen, bilirubin, lipids).

Technological Characteristics

Single-use disposable cartridge containing sensors, fluid pack, and waste chamber. pH/pCO2: direct potentiometry (Nernst equation). pO2: amperometry (Clark electrode). Sample volume: 95μL. Connectivity: i-STAT 1 analyzer. Sterilization: Not specified. Standards: CLSI EP05-A3, EP06, EP07, EP09c, EP17-A2, EP35, EP37.

Indications for Use

Indicated for patients requiring in vitro quantification of pH, PO2, and PCO2 in arterial, venous, or capillary whole blood for diagnosis, monitoring, and treatment of respiratory, metabolic, and acid-base disturbances. For prescription use in point-of-care or clinical laboratory settings.

Regulatory Classification

Identification

A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Predicate Devices

• RAPIDPoint 500e Blood Gas System (K192240)

Submission Summary (Full Text)

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October 27, 2023

Abbott Point of Care Inc. Jacquelyn Gesumaria Principal Regulatory Affairs Specialist 400 College Road East Princeton, New Jersey 08540

Re: K230285

Trade/Device Name: i-STAT CG8+ cartridge with the i-STAT 1 System Regulation Number: 21 CFR 862.1120 Regulation Name: Blood Gases (PCO2, PO2) And Blood pH Test System Regulatory Class: Class II Product Code: CHL Dated: September 28, 2023 Received: September 28, 2023

Dear Jacquelyn Gesumaria:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

# Paula V. Caposino -S

Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics 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) K230285

Device Name i-STAT CG8+ cartridge with the i-STAT 1 System

Indications for Use (Describe)

The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of H, partial pressure of oxygen (PO2), and partial pressure of carbon dioxide (PCO2) in arterial, venous, or capillary whole blood in point of care or clinical laboratory settings.

pH, PO2, and PCO2 measurements are used in the diagnosis, monitoring, and treatment of respiratory, metabolic and acid-base disturbances.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">❌</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</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.

# I. SUBMITTER INFORMATION

| Owner | Abbott Point of Care Inc.<br>400 College Road East<br>Princeton, NJ 08540 |
|---------------|------------------------------------------------------------------------------------------------|
| Contact | Primary: Jacquelyn Gesumaria<br>Principal Regulatory Affairs Specialist<br>Phone: [phone] |
| | Secondary: Mojgan Soleimani<br>Associate Director Regulatory Affairs<br>Phone: [phone] |
| Date Prepared | October 27, 2023 |

# II. DEVICE INFORMATION

| Proprietary Name | i-STAT CG8+ cartridge with the i-STAT 1 System |
|------------------|------------------------------------------------|
| Common Name | Blood gas test, analyzer, handheld |
| 510(k) Number | K230285 |

| Product Code | Device Classification<br>Name | Regulation<br>Number | Class | Panel |
|--------------|----------------------------------|----------------------|-------|--------------------|
| CHL | Electrode, Ion<br>Specific, pH | 862.1120 | II | Clinical Chemistry |
| CHL | Electrode, Ion<br>Specific, PCO2 | 862.1120 | II | Clinical Chemistry |
| CHL | Electrode, Ion<br>Specific PO2 | 862.1120 | II | Clinical Chemistry |

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# III. PREDICATE DEVICE

RAPIDPoint 500e Blood Gas System Proprietary Name

510(k) Number K192240

| Product<br>Code | Device Classification<br>Name | Regulation<br>Number | Class | Panel |
|-----------------|----------------------------------|----------------------|-------|--------------------|
| CHL | Electrode, Ion Specific, pH | 862.1120 | II | Clinical Chemistry |
| CHL | Electrode, Ion Specific,<br>PCO2 | 862.1120 | II | Clinical Chemistry |
| CHL | Electrode, Ion Specific PO2 | 862.1120 | II | Clinical Chemistry |

# IV. DEVICE DESCRIPTION

The i-STAT CG8+ cartridge is used with the i-STAT 1 analyzer as part of the i-STAT 1 System and contains test reagents to measure pH, partial pressure of oxygen (PO2), and partial pressure of carbon dioxide (PCO2) in arterial, venous or capillary whole blood.

The i-STAT 1 System is an in vitro diagnostic (IVD) medical device intended for the quantitative determination of various clinical chemistry tests contained within i-STAT cartridges using whole blood. The i-STAT 1 System consists of a portable blood analyzer (i-STAT 1 analyzer), single-use disposable test cartridges (i-STAT cartridges), liquid quality control and calibration verification materials, and accessories (i-STAT 1 Downloader/Recharger, i-STAT Electronic Simulator and i-STAT 1 Printer). The i-STAT 1 System, including the i-STAT CG8+ cartridge, is designed for use by trained medical professionals in point of care or clinical laboratory settings and is for prescription use only.

The i-STAT CG8+ cartridge contains the required sensors, a fluid pack (calibrant pouch), a sample entry well and closure, fluid channels, waste chamber, and the necessary mechanical features for controlled fluid movement within cartridge. The i-STAT cartridge format allows all the tests in the cartridge to be performed simultaneously. All the test steps and fluid movement occur within the i-STAT CG8+ cartridges require two to three drops of whole blood applied to the cartridge using a transfer device by the trained user before the cartridge is placed within the analyzer.

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 i-STAT CG8+ cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes).

# V. INTENDED USE STATEMENT

The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of pH, partial pressure of oxygen (PO2), and partial pressure of carbon dioxide (PCO2) in arterial, venous, or capillary whole blood in point of care or clinical laboratory settings.

pH, PO2, and PCO2 measurements are used in the diagnosis, monitoring, and treatment of respiratory, metabolic and acid-base disturbances.

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# VI. SUMMARY COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

| Table 1: Similarities and Differences (Test and Instrument): pH, PO2, and PCO2 in Arterial, Venous, and Capillary Whole Blood | | |
|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature or Characteristic | Candidate Device:<br>pH, PO2 and PCO2 Tests in the:<br><i>i-STAT CG8+</i> cartridge<br>with the <i>i-STAT 1 System</i> | Predicate Device:<br>pH, PO2 and PCO2 Tests in the<br>Siemens RAPIDPoint 500e<br>Blood Gas System<br>(K192240) |
| Intended Use | The <i>i-STAT CG8+</i> cartridge with the<br><i>i-STAT 1 System</i> is intended for use in<br>the <i>in vitro</i> quantification of sodium,<br>potassium, ionized calcium, glucose,<br>hematocrit, pH, partial pressure of<br>oxygen (PO2), and partial pressure of<br>carbon dioxide (PCO2) in arterial,<br>venous, or capillary whole blood in<br>point of care or clinical laboratory<br>settings.<br>pH, PO2, and PCO2 measurements are<br>used in the diagnosis, monitoring, and<br>treatment of respiratory, metabolic and<br>acid-base disturbances. | The RAPIDPoint 500e Blood Gas System is<br>intended for <i>in vitro</i> diagnostic use and is<br>designed to provide the determination in<br>whole blood for the following parameters:<br>• Partial pressure of carbon dioxide<br>• Partial pressure of oxygen<br>• pH<br>• Sodium<br>• Potassium<br>• Ionized Calcium<br>• Chloride<br>• Glucose<br>• Lactate<br>• Total Hemoglobin and fractions: FO2Hb,<br>FCOHb, FMetHb, FHHb<br>• Neonatal Bilirubin<br><br>The RAPIDPoint 500e Blood Gas System is<br>also intended for <i>in vitro</i> testing of pleural<br>fluid samples for the pH parameter. The pH<br>measurement of pleural fluid can be a<br>clinically useful tool in the management of<br>patients with parapneumonic effusions. The<br>following critical value applies to pleural<br>fluid pH: pH > 7.3 is measured in<br>uncomplicated parapneumonic effusions. All<br>pleural fluids with a pH measurement < 7.3<br>are referred to as complicated<br>parapneumonic effusions and are exudative<br>in nature. This test system is intended for<br>use in point of care or laboratory settings.<br>pCO2, pO2, pH: Measurements of blood<br>gases (pCO2, pO2) and blood pH are used in<br>the diagnosis and treatment of life-<br>threatening acid-base disturbances. |
| Device<br>Classification | Same | Class II |
| Product Code | Same | CHL |
| Table 1: Similarities and Differences (Test and Instrument): pH, PO2, and PCO2 in Arterial, Venous, and Capillary Whole Blood | | |
| Feature or<br>Characteristic | Candidate Device:<br>pH, PO2 and PCO2 Tests in the:<br><i>i-STAT CG8+</i> cartridge<br>with the <i>i-STAT 1</i> System | Predicate Device:<br>pH, PO2 and PCO2 Tests in the<br>Siemens RAPIDPoint 500e<br>Blood Gas System<br>(K192240) |
| Regulation<br>No. | Same | 862.1120 |
| Reportable<br>Range | pH<br>Same | pH<br>6.500 – 7.800 |
| | PO2<br>$5-700 mmHg$<br>$0.7-93.3 kPa$ | pO2<br>$10.0-700.0 mmHg$<br>$1.33-93.32 kPa$ |
| | PCO2<br>$5-130 mmHg$<br>$0.67-17.33 kPa$ | PCO2<br>$5.0-200.0 mmHg$<br>$0.66-26.66 kPa$ |
| Sample Type | Arterial, venous or capillary whole blood | Whole blood (Arterial, Venous and Capillary for all analytes)Pleural Fluid (for pH test only) |
| Sample<br>Volume | 95 μL | 100 μL |
| Sample<br>Preparation | Same | Ready to use |
| Sample<br>collection | Without anticoagulant (for arterial and venous whole blood sample types)With balanced heparin anticoagulant or lithium heparin anticoagulant (for arterial, venous, and capillary whole blood sample types) | With balanced heparin anticoagulant or lithium heparin anticoagulant |
| Traceability | pH<br>Traceable to NIST SRMs<br>186-I, 186-II, 185 and 187 | pH<br>Traceable to NIST SRM 186 reference materials via the IFCC blood reference method. |
| | PO2, PCO2<br>Traceable to NIST SRMs via commercially available certified specialty medical gas tanks | PO2, PCO2<br>Traceable to tonometered aqueous standards prepared using NIST traceable temperature and pressure standards and gravimetrically prepared precision gas standards. |
| Calibration | 1-point calibration using reagents contained within cartridge | 1-point, 2-point and full calibration using automated on board reagent |
| Table 1: Similarities and Differences (Test and Instrument): pH, PO2, and PCO2 in Arterial, Venous,<br>and Capillary Whole Blood | | |
| Feature or<br>Characteristic | Candidate Device:<br>pH, PO2 and PCO2 Tests in the:<br>i-STAT CG8+ cartridge<br>with the i-STAT 1 System | Predicate Device:<br>pH, PO2 and PCO2 Tests in the<br>Siemens RAPIDPoint 500e<br>Blood Gas System<br>(K192240) |
| Principle of<br>Measurement | pH, PCO2: Potentiometric measurement<br>between active working sensor and<br>independent reference sensor<br>PO2: Amperometric measurement of<br>oxygen reduction current | pH, PCO2: Potentiometric method<br>PO2: Amperometric measurement |
| Reagent<br>Format | Same | Cartridge |
| Storage<br>Conditions | Refrigerated at 2-8°C (35-46°F) until<br>expiration date<br>Room Temperature at 18-30°C (64-86°F)<br>for 2 months | Refrigerated at 2 to 8°C (35 to 46°F) until<br>stated "install-by-date"; 28 additional days<br>after installation on system<br>Room Temperature for up to 1 day |
| Analyzer Type | Handheld | Benchtop |

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#### PERFORMANCE CHARACTERISTICS VII.

### A. Analytical Performance

# a. Precision/Reproducibility:

### i. Precision 20 days (Aqueous materials)

The precision of the i-STAT pH, Partial Pressure of Oxygen (PO2), and Partial Pressure of Carbon Dioxide (PCO2) tests in the i-STAT CG8+ cartridge on the i-STAT 1 System was evaluated using five (5) levels of aqueous material. This 20day precision testing was based on CLSI document EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline – Third Edition. The study was conducted using multiple analyzers and one (1) test cartridge lot over 20 days at one site. Repeatability, between-run, between-day, and within-laboratory precision were estimated for each level. The results of the 20-day precision study for the i-STAT CG8+ cartridge on the i-STAT 1 System are shown in Table 2.

| Table 2: Results of 20-Day Precision of the i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer | | | | | | | | | | | | |
|--------------------------------------------------------------------------------------------|----------------|----|--------|---------------|------|-------------|------|-------------|------|-----------------------|------|--|
| Test | Fluid<br>Level | N | Mean | Repeatability | | Between-run | | Between-day | | Within-<br>Laboratory | | |
| (units) | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | |
| pH<br>(pH units) | CV L1 | 80 | 6.5831 | 0.00284 | 0.04 | 0.00354 | 0.05 | 0.00162 | 0.02 | 0.00482 | 0.07 | |
| | CV L2 | 80 | 7.0326 | 0.00165 | 0.02 | 0.00121 | 0.02 | 0.00102 | 0.01 | 0.00229 | 0.03 | |
| | CV L3 | 80 | 7.4574 | 0.00118 | 0.02 | 0.00170 | 0.02 | 0.00065 | 0.01 | 0.00217 | 0.03 | |
| | CV L4 | 80 | 7.6365 | 0.00133 | 0.02 | 0.00201 | 0.03 | 0.00072 | 0.01 | 0.00251 | 0.03 | |
| | CV L5 | 80 | 7.9612 | 0.00244 | 0.03 | 0.00188 | 0.02 | 0.00090 | 0.01 | 0.00321 | 0.04 | |
| PO2<br>(mmHg) | CV L1 | 80 | 75.7 | 1.93 | 2.54 | 1.45 | 1.92 | 0.77 | 1.02 | 2.53 | 3.35 | |
| | CV L2 | 80 | 87.3 | 1.81 | 2.07 | 0.46 | 0.53 | 0.55 | 0.63 | 1.94 | 2.23 | |
| | CV L3 | 80 | 115.0 | 2.40 | 2.08 | 1.76 | 1.53 | 0.47 | 0.41 | 3.01 | 2.62 | |
| | CV L4 | 80 | 144.1 | 2.74 | 1.90 | 2.62 | 1.82 | 1.02 | 0.70 | 3.92 | 2.72 | |
| | CV L5 | 80 | 371.6 | 6.25 | 1.68 | 8.29 | 2.23 | 2.97 | 0.80 | 10.80 | 2.91 | |

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| Table 2: Results of 20-Day Precision of the i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer | | | | | | | | | | | | |
|--------------------------------------------------------------------------------------------|----------------|----|-------|---------------|------|-------------|------|-------------|------|-----------------------|------|--|
| Test<br>(units) | Fluid<br>Level | N | Mean | Repeatability | | Between-run | | Between-day | | Within-<br>Laboratory | | |
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | |
| PCO2<br>(mmHg) | CV L1 | 80 | 88.55 | 0.781 | 0.88 | 0.973 | 1.10 | 0.392 | 0.44 | 1.307 | 1.48 | |
| | CV L2 | 80 | 54.96 | 0.598 | 1.09 | 0.139 | 0.25 | 0.055 | 0.10 | 0.616 | 1.12 | |
| | CV L3 | 80 | 28.90 | 0.300 | 1.04 | 0.082 | 0.28 | 0.082 | 0.28 | 0.321 | 1.11 | |
| | CV L4 | 80 | 22.59 | 0.268 | 1.19 | 0.112 | 0.50 | 0.066 | 0.29 | 0.298 | 1.32 | |
| | CV L5 | 80 | 13.81 | 0.335 | 2.42 | 0.157 | 1.13 | 0.181 | 1.31 | 0.412 | 2.98 | |

### ii. Multi-site and operator-to-operator precision (Aqueous materials)

Multi-day precision testing was performed at three (3) sites using a panel of aqueous solutions containing five (5) levels of pH, PO2, and PCO2. At each site, each level was tested once a day by two (2) operators for five (5) days on six (6) i-STAT 1 analyzers using i-STAT CG8+ cartridges. Within-run, between-day, betweenoperator and within-site (total) variance components were calculated by site. These components were also calculated for all sites combined and provided in the Table 3 below.

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| Table 3: Multi-Day Precision of the i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer | | | | | | | | | | | | | | | |
|------------------------------------------------------------------------------------|----------------|----|--------|------------|------|-------------|------|------------------|------|---------------------|------|--------------|------|---------|------|
| Test<br>(units) | Fluid<br>Level | N | Mean | Within-Run | | Between-Day | | Between-Operator | | Within-Site (Total) | | Between-Site | | Overall | |
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| pH<br>(pH units) | CV L1 | 90 | 6.5829 | 0.00395 | 0.06 | 0.00267 | 0.04 | 0.00329 | 0.05 | 0.00579 | 0.09 | 0.00000 | 0.00 | 0.00579 | 0.09 |
| | CV L2 | 90 | 7.0332 | 0.00317 | 0.05 | 0.00135 | 0.02 | 0.00054 | 0.01 | 0.00349 | 0.05 | 0.00000 | 0.00 | 0.00349 | 0.05 |
| | CV L3 | 96 | 7.4571 | 0.00231 | 0.03 | 0.00080 | 0.01 | 0.00085 | 0.01 | 0.00258 | 0.03 | 0.00000 | 0.00 | 0.00258 | 0.03 |
| | CV L4 | 90 | 7.6372 | 0.00184 | 0.02 | 0.00038 | 0.01 | 0.00116 | 0.02 | 0.00221 | 0.03 | 0.00000 | 0.00 | 0.00221 | 0.03 |
| | CV L5 | 90 | 7.9627 | 0.00256 | 0.03 | 0.00035 | 0.00 | 0.00110 | 0.01 | 0.00281 | 0.04 | 0.00000 | 0.00 | 0.00281 | 0.04 |
| PO2<br>(mmHg) | CV L1 | 91 | 81.1 | 2.73 | 3.37 | 1.00 | 1.23 | 1.56 | 1.92 | 3.30 | 4.07 | 0.00 | 0.00 | 3.30 | 4.07 |
| | CV L2 | 90 | 91.2 | 3.34 | 3.67 | 1.31 | 1.43 | 0.84 | 0.92 | 3.69 | 4.04 | 0.00 | 0.00 | 3.69 | 4.04 |
| | CV L3 | 97 | 118.3 | 2.38 | 2.01 | 1.06 | 0.89 | 0.93 | 0.78 | 2.76 | 2.34 | 0.99 | 0.84 | 2.94 | 2.48 |
| | CV L4 | 90 | 147.3 | 2.39 | 1.62 | 2.17 | 1.48 | 2.29 | 1.56 | 3.96 | 2.69 | 0.00 | 0.00 | 3.96 | 2.69 |
| | CV L5 | 90 | 367.7 | 6.27 | 1.71 | 4.25 | 1.16 | 9.62 | 2.62 | 12.24 | 3.33 | 0.00 | 0.00 | 12.24 | 3.33 |
| PCO2<br>(mmHg) | CV L1 | 90 | 88.67 | 1.308 | 1.48 | 0.349 | 0.39 | 0.620 | 0.70 | 1.489 | 1.68 | 0.000 | 0.00 | 1.489 | 1.68 |
| | CV L2 | 90 | 56.08 | 0.652 | 1.16 | 0.379 | 0.68 | 0.000 | 0.00 | 0.754 | 1.35 | 0.000 | 0.00 | 0.754 | 1.35 |
| | CV L3 | 96 | 29.42 | 0.332 | 1.13 | 0.173 | 0.59 | 0.033 | 0.11 | 0.376 | 1.28 | 0.000 | 0.00 | 0.376 | 1.28 |
| | CV L4 | 90 | 22.73 | 0.379 | 1.67 | 0.166 | 0.73 | 0.105 | 0.46 | 0.427 | 1.88 | 0.000 | 0.00 | 0.427 | 1.88 |
| | CV L5 | 90 | 13.17 | 0.381 | 2.89 | 0.188 | 1.43 | 0.123 | 0.93 | 0.442 | 3.36 | 0.181 | 1.37 | 0.477 | 3.63 |

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# iii. Precision (Whole Blood)

Whole blood precision of the i-STAT pH, PO2, and PCO2 tests in the i-STAT CG8+ cartridge on the i-STAT 1 System was evaluated using arterial, venous, and capillary1 whole blood specimens collected with lithium heparin. The whole blood precision was assessed using the duplicate test results collected across multiple point of care sites. The results are summarized in Table 4.

| Test<br>(units) | Sample Type | Sample Range | N | Mean | SD | %CV |
|------------------|--------------------------|--------------|-----|--------|---------|-------|
| pH<br>(pH units) | Venous Whole<br>Blood | 6.500-7.300 | 14 | 7.0076 | 0.00378 | 0.05 |
| | Venous Whole<br>Blood | >7.300-7.450 | 95 | 7.3790 | 0.00605 | 0.08 |
| | Venous Whole<br>Blood | >7.450-7.800 | 9 | 7.5257 | 0.00350 | 0.05 |
| pH<br>(pH units) | Arterial Whole<br>Blood | 6.500-7.300 | 7 | 7.2059 | 0.00292 | 0.04 |
| | Arterial Whole<br>Blood | >7.300-7.450 | 100 | 7.3772 | 0.00574 | 0.08 |
| | Arterial Whole<br>Blood | >7.450-7.800 | 41 | 7.4704 | 0.00585 | 0.08 |
| pH<br>(pH units) | Capillary Whole<br>Blood | 6.500-7.300 | 0 | N/A | N/A | N/A |
| | Capillary Whole<br>Blood | >7.300-7.450 | 108 | 7.4075 | 0.01847 | 0.25 |
| | Capillary Whole<br>Blood | >7.450-7.800 | 45 | 7.4729 | 0.02508 | 0.34 |
| PO2<br>(mmHg) | Venous Whole<br>Blood | 10-40 | 72 | 30.5 | 0.98 | 3.21 |
| | Venous Whole<br>Blood | >40-50 | 15 | 44.7 | 0.68 | 1.53 |
| | Venous Whole<br>Blood | >50-100 | 20 | 58.9 | 1.17 | 1.99 |
| | Venous Whole<br>Blood | >100-250 | 5 | 141.1 | 4.72 | 3.35 |
| | Venous Whole<br>Blood | >250-700 | 6 | 550.1 | 5.35 | 0.97 |
| PO2<br>(mmHg) | Arterial Whole<br>Blood | 10-40 | 2 | 37.3 | 1.12 | 3.00 |
| | Arterial Whole<br>Blood | >40-50 | 3 | 48.2 | 1.22 | 2.54 |
| | Arterial Whole<br>Blood | >50-100 | 61 | 76.7 | 1.26 | 1.64 |
| | Arterial Whole<br>Blood | >100-250 | 66 | 161.2 | 3.87 | 2.40 |
| | Arterial Whole<br>Blood | >250-700 | 15 | 323.3 | 7.45 | 2.30 |
| PO2<br>(mmHg) | Capillary Whole<br>Blood | 10-40 | 5 | 36.3 | 1.52 | 4.18 |
| | Capillary Whole<br>Blood | >40-50 | 13 | 45.5 | 2.49 | 5.47 |
| | Capillary Whole<br>Blood | >50-100 | 136 | 70.4 | 7.50 | 10.65 |
| | Capillary Whole<br>Blood | >100-250 | 0 | N/A | N/A | N/A |
| | Capillary Whole<br>Blood | >250-700 | 0 | N/A | N/A | N/A |
| PCO2<br>(mmHg) | Venous Whole<br>Blood | 5.0-35.0 | 27 | 33.30 | 0.555 | 1.67 |
| | Venous Whole<br>Blood | >35.0-50.0 | 70 | 45.32 | 0.777 | 1.71 |
| | Venous Whole<br>Blood | >50.0-62.5 | 14 | 55.79 | 1.592 | 2.85 |
| | Venous Whole<br>Blood | >62.5-130.0 | 9 | 97.07 | 1.312 | 1.35 |
| PCO2<br>(mmHg) | Arterial Whole<br>Blood | 5.0-35.0 | 51 | 33.76 | 0.714 | 2.12 |
| | Arterial Whole<br>Blood | >35.0-50.0 | 85 | 43.56 | 0.958 | 2.20 |
| | Arterial Whole<br>Blood | >50.0-62.5 | 10 | 60.78 | 0.489 | 0.81 |
| | Arterial Whole<br>Blood | >62.5-130.0 | 2 | 87.85 | 0.570 | 0.65 |
| PCO2<br>(mmHg) | Capillary Whole<br>Blood | 5.0-35.0 | 51 | 31.23 | 2.048 | 6.56 |
| | Capillary Whole<br>Blood | >35.0-50.00 | 97 | 40.16 | 1.749 | 4.36 |
| | Capillary Whole<br>Blood | >50.0-62.5 | 5 | 54.82 | 2.835 | 5.17 |
| | Capillary Whole<br>Blood | >62.5-130 | 0 | N/A | N/A | N/A |

¹ The capillary whole blood clinical precision study design involved the performance of two individual fingersticks, collected independently by two operators into two separate capillary tubes and tested on two (2) i-STAT CG8+ cartridges.

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# b. Linearity/assay reportable range:

#### Linearity i.

The study was designed based on CLSI EP06-Ed2: Evaluation of the Linearity of Quantitative Measurement Procedures - Second Edition.

The linearity of the i-STAT pH, PO2, and PCO2 tests in the i-STAT CG8+ cartridge with the i-STAT 1 System was evaluated by preparing whole blood samples of varying analyte levels for each i-STAT test. The i-STAT pH, PO2, and PCO2 tests in the i-STAT CG8+ cartridge demonstrated linearity over the reportable range for each i-STAT test. Regression summary of the response for each i-STAT test versus the concentration of the whole blood samples of varying analyte levels is provided in Table 5 for i-STAT CG8+ cartridge.

| Table 5: Regression Summary for the i-STAT pH, PO2 and PCO2 tests in the i-STAT CG8+ | | | | | | |
|--------------------------------------------------------------------------------------|----------|------------------|-----------------|-------|-----------|--------|
| Cartridge on the i-STAT 1 Analyzer | | | | | | |
| Test | Units | Reportable Range | Range Tested | Slope | Intercept | R2 |
| pH | pH units | 6.500 – 7.800 | 6.4290 – 7.8522 | 1.011 | -0.098 | 0.9994 |
| PO2 | mmHg | 5 – 700 | 4.4 – 700.0 | 0.977 | 1.062 | 0.9956 |
| PCO2 | mmHg | 5.0 – 130.0 | 2.40 – 148.38 | 1.029 | -1.144 | 0.9991 |

# c. Detection Limit

#### i. Limit of Quantitation (LoQ)

The study was based on the CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures: Approved Guideline – Second Edition.

The LoQ of the i-STAT pH, PO2 and PCO2 tests in the i-STAT CG8+ cartridge was evaluated on the i-STAT 1 analyzer using two (2) i-STAT CG8+ cartridge lots and whole blood that was altered to a low analyte level for each i-STAT test. The LoQ for the i-STAT pH, PO2, and PCO2 tests in the i-STAT CG8+ cartridge and i-STAT EG7+ cartridge was determined to be at or below the lower limit of the reportable range for each of the i-STAT tests as shown in Table 6.

| Table 6: Summary of LoQ Results for i-STAT Tests in the i-STAT CG8+ Cartridge | | |
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