i-STAT G3+ cartridge with the i-STAT 1 System
Device Facts
| Record ID | K223857 |
|---|---|
| Device Name | i-STAT G3+ cartridge with the i-STAT 1 System |
| Applicant | Abbott Point of Care, Inc. |
| Product Code | CHL · Clinical Chemistry |
| Decision Date | Sep 15, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1120 |
| Device Class | Class 2 |
Intended Use
The i-STAT G3+ 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
The i-STAT G3+ cartridge is a single-use, self-contained disposable unit used with the i-STAT 1 analyzer. It processes 95 μL of whole blood (arterial, venous, or capillary) to measure pH, pO2, and pCO2. The cartridge contains sensors, a fluid pouch with calibrator, and internal fluid channels. pH and pCO2 are measured via direct potentiometry using the Nernst equation; pO2 is measured amperometrically using a Clark-type electrode. The system is used in point-of-care or clinical laboratory settings by healthcare professionals. Results are displayed on the i-STAT 1 analyzer, providing immediate data for the diagnosis, monitoring, and treatment of respiratory, metabolic, and acid-base disturbances, enabling rapid clinical decision-making.
Clinical Evidence
No clinical trials were performed. Evidence consists of analytical performance data including precision (within-site and multi-site), linearity (CLSI EP06-A2), interference testing (CLSI EP07), and method comparison (CLSI EP09c) against a comparative method using 487 arterial/venous and 206 capillary samples. Results showed high correlation (r ≥ 0.96) and acceptable bias at medical decision levels.
Technological Characteristics
Single-use disposable cartridge; potentiometric sensors for pH and pCO2; amperometric Clark-type electrode for pO2. Operates with i-STAT 1 analyzer. Traceable to NIST SRMs. Sample volume 95 μL. Sterilization/materials not specified beyond standard clinical chemistry requirements. Connectivity via i-STAT 1 system.
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 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)
Related Devices
- K230285 — i-STAT CG8+ cartridge with the i-STAT 1 System · Abbott Point of Care, Inc. · Oct 27, 2023
- K200492 — i-STAT CG4+ Cartridge with the i-STAT 1 System · Abbott Point of Care, Inc. · Apr 9, 2020
Submission Summary (Full Text)
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September 15. 2023
Abbott Point of Care Inc. Jacquelyn Gesumaria Principal Specialist Regulatory Affairs 400 College Road East Princeton, New Jersey 08540
Re: K223857
Trade/Device Name: i-STAT G3+ 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: August 18, 2023 Received: August 18, 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 (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 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
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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 (QS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
K223857
Device Name i-STAT G3+ cartridge with the i-STAT 1 System
Indications for Use (Describe)
The i-STAT G3+ 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.
| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 Specialist Regulatory Affairs<br>Phone: +1 609-454-9384 |
| | Secondary: Mojgan Soleimani<br>Associate Director Regulatory Affairs<br>Phone: +1 613-295-0932 |
| Date Prepared | Sep 15, 2023 |
# II. DEVICE INFORMATION
Proprietary Name i-STAT G3+ cartridge with the i-STAT 1 System
Common Name Blood gas test, analyzer, handheld
510(k) Number: K223857
| Product Code | Device Classification<br>Name | Regulation<br>Number | Class | Panel |
|--------------|----------------------------------|----------------------|-------|--------------------|
| CHL | Electrode, Ion Specific,<br>pH | 862.1120 | II | Clinical Chemistry |
| CHL | Electrode, Ion Specific,<br>PCO2 | 862.1120 | II | Clinical Chemistry |
| CHL | Electrode, Ion Specific<br>PO2 | 862.1120 | II | Clinical Chemistry |
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### III. PREDICATE DEVICE
Proprietary Name RAPIDPoint 500e Blood Gas System
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 G3+ cartridge is used with the i-STAT 1 analyzer as part of the i-STAT 1 Sustem 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 G3+ 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 G3+ 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 movements occur within the -STAT G3+ cartridge. The i-STAT 1 analyzer interacts with the i-STAT G3+ cartridge to move fluid across the sensors and generate a quantitative result. 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 analyzer interacts with the cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes).
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# V. INTENDED USE STATEMENT
The i-STAT G3+ 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.
# VI. SUMMARY COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| Table 1: Similarities and Differences: System (Test and Instrument): pH, PO2, and PCO2 in Arterial,<br>Venous and Capillary Whole Blood | | |
|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature or<br>Characteristic | Candidate Device:<br>pH, PO2 and PCO2 Tests in the <i>i-STAT</i><br><i>G3+</i> cartridge with the <i>i-STAT 1</i><br>System | Predicate Device:<br>pH, PO2 and PCO2 Tests with the<br>RAPIDPoint 500e Blood Gas System<br>(K192240) |
| Intended Use | The <i>i-STAT G3+</i> cartridge with the<br><i>i-STAT 1</i> System is intended for use in<br>the <i>in vitro</i> quantification of pH,<br>partial pressure of oxygen (PO2), and<br>partial pressure of carbon dioxide<br>(PCO2) in arterial, venous, or capillary<br>whole blood in point of care or<br>clinical laboratory settings.<br><br>pH, PO2, and PCO2 measurements are<br>used in the diagnosis, monitoring,<br>and treatment of respiratory,<br>metabolic, and acid-base<br>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<br>parameters: Partial pressure of carbon dioxide Partial pressure of oxygen pH Sodium Potassium Ionized Calcium Chloride Glucose Lactate Total Hemoglobin and fractions:<br>FO2Hb, FCOHb, FMetHb, FHHb Neonatal Bilirubin The RAPIDPoint 500e Blood Gas System is<br>also intended for <i>in vitro</i> testing of<br>pleural fluid samples for the pH<br>parameter. The pH measurement of<br>pleural fluid can be a clinically useful tool<br>in the management of patients with<br>parapneumonic effusions.<br><br>The following critical value applies to<br>pleural fluid pH: pH > 7.3 is measured in<br>uncomplicated parapneumonic effusions. |
| Table 1: Similarities and Differences: System (Test and Instrument): pH, PO2, and PCO2 in Arterial,<br>Venous and Capillary Whole Blood | | |
| Feature or<br>Characteristic | Candidate Device:<br>pH, PO2 and PCO2 Tests in the <i>i-STAT</i><br>G3+ cartridge with the <i>i-STAT 1</i><br>System | Predicate Device:<br>pH, PO2 and PCO2 Tests with the<br>RAPIDPoint 500e Blood Gas System<br>(K192240) |
| | | All pleural fluids with a pH measurement<br>< 7.3 are referred to as complicated<br>parapneumonic effusions and are<br>exudative in nature. This test system is<br>intended for use in point of care or<br>laboratory settings. |
| | | $pCO_2, pO_2, pH$ : Measurements of blood<br>gases ( $pCO_2, pO_2$ ) and blood pH are used<br>in the diagnosis and treatment of life-<br>threatening acid-base disturbances. |
| Device<br>Classification | Same | Class II |
| Product Code | Same | CHL |
| Regulation<br>Number | 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<br>blood | • Whole blood (Arterial, Venous and<br>Capillary for all analytes)<br>• Pleural Fluid (for pH only) |
| Sample Volume | 95 µL | 100 µL |
| Sample<br>Preparation | Same | Ready to Use |
| Sample<br>Collection | • Without anticoagulant<br>• With balanced heparin<br>anticoagulant or lithium heparin<br>anticoagulant | With balanced heparin anticoagulant or<br>lithium heparin anticoagulant |
| Table 1: Similarities and Differences: System (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 <i>i-STAT</i> G3+ cartridge with the <i>i-STAT</i> 1 System | Predicate Device:<br>pH, PO2 and PCO2 Tests with the RAPIDPoint 500e Blood Gas System (K192240) |
| Traceability | pH<br>Traceable to NIST SRMs 186-I, 186-II, 185 and 187<br><br>PO2, PCO2<br>Traceable to NIST SRMs via commercially available certified specialty medical gas tanks | pH<br>Traceable to NIST SRM 186 reference materials via the IFCC blood reference method.<br><br>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 on-board contained within cartridge | 1-point, 2-point and full calibration using automated on-board reagent |
| Time to Test/<br>Sample Stability<br>(Time from collection to sample fill) | Without anticoagulant: | With anticoagulant: |
| | pH, PO2, PCO2 (arterial and venous)<br>within 3 minutes<br><br>With anticoagulant:<br>pH, PO2, PCO2 (arterial and venous)<br>within 10 minutes<br><br>pH, PO2, PCO2 (capillary)<br>within 3 minutes | pH, PO2, PCO2<br>within 10 minutes |
| Principle of Measurement | pH, PCO2: Potentiometric measurement between active working sensor and independent reference sensor.<br><br>PO2: Amperometric measurement of oxygen reduction current. | pH, PCO2: Potentiometric method<br>PO2: Amperometric measurement |
| Reagent Format | Same | Cartridge |
| Storage Conditions | Refrigerated at 2 to 8°C (35 to 46°F) until expiration date<br><br>Room Temperature at 18-30°C (64-86°F) for 2 months | Refrigerated at 2 to 8°C (35 to 46°F) until stated "install-by-date"; 28 additional days after installation on system<br><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. PO2, and PCO2 tests in the i-STAT G3+ cartridge with the i-STAT 1 System was evaluated using five (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 was conducted using multiple analyzers and one (1) test cartridge lot over at least 20 days at one (1) 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 G;3+ cartridge on the i-STAT 1 System are shown in Table 2:.
| Test<br>(units) | Fluid<br>Level | N | Mean | Repeatability | | Between-run | | Between-day | | Within-<br>Laboratory | |
|------------------|----------------|----|--------|---------------|------|-------------|------|-------------|------|-----------------------|------|
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| pH<br>(pH units) | CV L1 | 81 | 6.5796 | 0.00314 | 0.05 | 0.00401 | 0.06 | 0.00184 | 0.03 | 0.00541 | 0.08 |
| | CV L2 | 82 | 7.0335 | 0.00251 | 0.04 | 0.00320 | 0.05 | 0.00063 | 0.01 | 0.00411 | 0.06 |
| | CV L3 | 85 | 7.4611 | 0.00256 | 0.03 | 0.00109 | 0.01 | 0.00084 | 0.01 | 0.00291 | 0.04 |
| | CV L4 | 80 | 7.6425 | 0.00339 | 0.04 | 0.00103 | 0.01 | 0.00085 | 0.01 | 0.00364 | 0.05 |
| | CV L5 | 80 | 7.9702 | 0.00324 | 0.04 | 0.00109 | 0.01 | 0.00081 | 0.01 | 0.00351 | 0.04 |
| PO₂<br>(mmHg) | CV L1 | 81 | 75.7 | 2.25 | 2.97 | 0.78 | 1.03 | 0.59 | 0.78 | 2.45 | 3.24 |
| | CV L2 | 82 | 87.9 | 1.69 | 1.92 | 1.10 | 1.25 | 0.84 | 0.96 | 2.18 | 2.48 |
| | CV L3 | 85 | 115.5 | 2.09 | 1.81 | 1.75 | 1.51 | 0.92 | 0.80 | 2.88 | 2.49 |
| | CV L4 | 80 | 146.0 | 2.90 | 1.99 | 2.87 | 1.97 | 1.24 | 0.85 | 4.27 | 2.92 |
| | CV L5 | 81 | 388.7 | 6.63 | 1.71 | 8.37 | 2.15 | 3.67 | 0.95 | 11.29 | 2.90 |
| PCO₂<br>(mmHg) | CV L1 | 81 | 89.21 | 0.792 | 0.89 | 1.161 | 1.30 | 0.538 | 0.60 | 1.505 | 1.69 |
| | CV L2 | 82 | 56.43 | 0.470 | 0.83 | 0.288 | 0.51 | 0.149 | 0.26 | 0.571 | 1.01 |
| | CV L3 | 85 | 29.32 | 0.288 | 0.98 | 0.128 | 0.44 | 0.076 | 0.26 | 0.324 | 1.11 |
| | CV L4 | 80 | 22.48 | 0.356 | 1.58 | 0.157 | 0.70 | 0.057 | 0.25 | 0.393 | 1.75 |
| | CV L5 | 80 | 12.06 | 0.308 | 2.55 | 0.082 | 0.68 | 0.092 | 0.76 | 0.331 | 2.75 |
| Table 2: 20-Day Precision of i-STAT G3+ Cartridge on the i-STAT 1 Analyzer | |
|----------------------------------------------------------------------------|--|
|----------------------------------------------------------------------------|--|
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## 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 material containing five (5) levels of pH, PO2, At each site, each level was tested once per day by two (2) days on six (6) i-STAT 1 analyzers using one (1) lot of i-STAT (33+ cartridges. Within-run, between-day, between-operator 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.
| Table 3: Multi-Day Precision of i-STAT G3+ Cartridge on the i-STAT 1 Analyzer | | | | | | | | | | | | | | | |
|-------------------------------------------------------------------------------|----------------|-------|--------|------------|-------|-------------|-------|----------------------|-------|------------------------|-------|--------------|-------|---------|-------|
| Test<br>(units) | Fluid<br>Level | N | Mean | Within-Run | | Between-Day | | Between-<br>Operator | | Within-Site<br>(Total) | | Between-Site | | Overall | |
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| | CV L1 | 90 | 6.5790 | 0.00465 | 0.07 | 0.00224 | 0.03 | 0.00170 | 0.03 | 0.00544 | 0.08 | 0.00227 | 0.03 | 0.00589 | 0.09 |
| | CV L2 | 90 | 7.0342 | 0.00228 | 0.03 | 0.00179 | 0.03 | 0.00138 | 0.02 | 0.00321 | 0.05 | 0.00000 | 0.00 | 0.00321 | 0.05 |
| pH<br>(pH units) | CV L3 | 90 | 7.4619 | 0.00274 | 0.04 | 0.00102 | 0.01 | 0.00054 | 0.01 | 0.00297 | 0.04 | 0.00081 | 0.01 | 0.00308 | 0.04 |
| | CV L4 | 90 | 7.6414 | 0.00236 | 0.03 | 0.00142 | 0.02 | 0.00141 | 0.02 | 0.0031 | 0.04 | 0.00000 | 0.00 | 0.00310 | 0.04 |
| | CV L5 | 90 | 7.9678 | 0.00247 | 0.03 | 0.00000 | 0.00 | 0.00146 | 0.02 | 0.00287 | 0.04 | 0.00000 | 0.00 | 0.00287 | 0.04 |
| | CV L1 | 90 | 77.9 | 3.16 | 4.05 | 1.13 | 1.45 | 0.00 | 0.00 | 3.35 | 4.30 | 1.85 | 2.37 | 3.83 | 4.91 |
| | CV L2 | 90 | 88.1 | 2.39 | 2.72 | 1.58 | 1.79 | 0.00 | 0.00 | 2.87 | 3.26 | 1.66 | 1.88 | 3.31 | 3.76 |
| PO2<br>(mmHg) | CV L3 | 92 | 114.5 | 2.07 | 1.81 | 2.48 | 2.16 | 0.49 | 0.43 | 3.26 | 2.85 | 1.59 | 1.39 | 3.63 | 3.17 |
| | CV L4 | 90 | 144.1 | 3.03 | 2.10 | 2.86 | 1.98 | 1.22 | 0.85 | 4.34 | 3.01 | 1.57 | 1.09 | 4.61 | 3.20 |
| | CV L5 | 90 | 373.4 | 7.32 | 1.96 | 7.32 | 1.96 | 7.77 | 2.08 | 12.94 | 3.47 | 0.00 | 0.00 | 12.94 | 3.47 |
| | | CV L1 | 90 | 90.42 | 1.497 | 1.66 | 0.416 | 0.46 | 0.000 | 0.00 | 1.553 | 1.72 | 0.000 | 0.00 | 1.553 |
| | | CV L2 | 90 | 57.40 | 0.767 | 1.34 | 0.195 | 0.34 | 0.000 | 0.00 | 0.791 | 1.38 | 0.206 | 0.36 | 0.818 |
| PCO2<br>(mmHg) | CV L3 | 90 | 29.80 | 0.600 | 2.01 | 0.203 | 0.68 | 0.290 | 0.97 | 0.697 | 2.34 | 0.275 | 0.92 | 0.749 | 2.51 |
| | CV L4 | 90 | 22.83 | 0.344 | 1.51 | 0.168 | 0.73 | 0.182 | 0.80 | 0.424 | 1.86 | 0.189 | 0.83 | 0.464 | 2.03 |
| | CV L5 | 90 | 12.28 | 0.461 | 3.75 | 0.043 | 0.35 | 0.045 | 0.37 | 0.465 | 3.79 | 0.058 | 0.48 | 0.469 | 3.82 |
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### iii. Precision (Whole Blood)
Whole blood precision of the i-STAT pH, PO2, and PCO2 tests in the i-STAT G3+ 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(outliers excluded) and Table 5 (outliers included):
| | Table 4: Whole Blood Precision of Arterial, Venous, and Capillary for i-STAT G3+ Cartridge on the i-STAT 1 Analyzer (outliers excluded) | | | | | |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------|---------------|-----|--------|---------|------|
| Test<br>(units) | Sample Type | Sample Range | N | Mean | SD | %CV |
| pH<br>(pH units) | Venous<br>Whole Blood | 6.500-7.300 | 24 | 7.1110 | 0.00593 | 0.08 |
| | | >7.300-7.450 | 108 | 7.3799 | 0.00591 | 0.08 |
| | | >7.450-7.800 | 9 | 7.5634 | 0.00856 | 0.11 |
| | Arterial<br>Whole Blood | 6.500-7.300 | 6 | 7.2402 | 0.00877 | 0.12 |
| | | >7.300-7.450 | 104 | 7.3894 | 0.00913 | 0.12 |
| | | >7.450-7.800 | 26 | 7.4889 | 0.00701 | 0.09 |
| | Capillary<br>Whole Blood | 6.500-7.300 | 1 | 7.2930 | 0.00000 | 0.00 |
| | | >7.300-7.450* | 113 | 7.4110 | 0.01747 | 0.24 |
| | | >7.450-7.800* | 43 | 7.4760 | 0.01696 | 0.23 |
| PO2<br>(mmHg) | Venous<br>Whole Blood | 10-40 | 96 | 26.6 | 1.03 | 3.87 |
| | | >40-50 | 22 | 44.8 | 1.11 | 2.47 |
| | | >50-100 | 14 | 68.1 | 1.60 | 2.35 |
| | | >100-250 | 3 | 176.7 | 2.89 | 1.63 |
| | | >250-700 | 7 | 557.3 | 10.14 | 1.82 |
| | Arterial<br>Whole Blood | 10-40 | 1 | 38.5 | 0.71 | 1.84 |
| | | >40-50 | 0 | NA | NA | NA |
| | | >50-100 | 64 | 79.8 | 1.35 | 1.70 |
| | | >100-250 | 70 | 150.8 | 3.67 | 2.43 |
| | | >250-700 | 4 | 388.0 | 9.55 | 2.46 |
| | Capillary<br>Whole Blood | 10-40 | 2 | 38.5 | 2.89 | 7.50 |
| | | >40-50 | 18 | 45.6 | 3.76 | 8.25 |
| | | >50-100* | 134 | 69.9 | 6.12 | 8.76 |
| | | >100-250* | 3 | 109.8 | 6.79 | 6.19 |
| | | >250-700 | 0 | NA | NA | NA |
| PCO2<br>(mmHg) | Venous<br>Whole Blood | 5.0-35.0 | 10 | 24.43 | 0.326 | 1.33 |
| | | >35.0-50.0 | 85 | 45.29 | 0.721 | 1.59 |
| | | >50.0-62.5 | 29 | 55.85 | 0.597 | 1.07 |
| | | >62.5-130.0 | 15 | 96.53 | 1.061 | 1.10 |
| | Arterial<br>Whole Blood | 5.0-35.0 | 35 | 31.13 | 0.525 | 1.69 |
| | | >35.0-50.0 | 87 | 44.61 | 0.747 | 1.68 |
| | | >50.0-62.5 | 9 | 58.33 | 1.602 | 2.75 |
| | | >62.5-130.0 | 5 | 68.62 | 0.937 | 1.37 |
| | Capillary<br>Whole Blood | 5.0-35.0* | 48 | 32.06 | 1.488 | 4.64 |
| | | >35.0-50.0* | 107 | 39.77 | 1.709 | 4.30 |
| | | >50.0-62.5 | 1 | 60.30 | 0.000 | 0.00 |
| | | >62.5-130.0 | 1 | 66.50 | 2.404 | 3.62 |
*Results with outliers excluded
<sup>1</sup> 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 G3+ cartridges.
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| | | Table 5: Whole Blood Precision of Arterial, Venous, and Capillary for i-STAT G3+ Cartridge on the i-STAT 1 | | | | |
|------------------|------------------------------|------------------------------------------------------------------------------------------------------------|-----|--------|---------|--------|
| | Analyzer (outliers included) | | | | | |
| Test<br>(uUnits) | Sample Type | Sample Range | N | Mean | SD | CV (%) |
| | Venous | 6.500-7.300 | 24 | 7.1110 | 0.00593 | 0.08 |
| | Whole Blood | >7.300-7.450 | 108 | 7.3799 | 0.00591 | 0.08 |
| | | >7.450-7.800 | 9 | 7.5634 | 0.00856 | 0.11 |
| | | 6.500-7.300 | 6 | 7.2402 | 0.00877 | 0.12 |
| pH<br>(pH units) | Arterial | >7.300-7.450 | 104 | 7.3894 | 0.00913 | 0.12 |
| | Whole Blood | >7.450-7.800 | 26 | 7.4889 | 0.00701 | 0.09 |
| | | 6.500-7.300 | 1 | 7.2930 | 0.00000 | 0.00 |
| | Capillary Whole | >7.300-7.450* | 114 | 7.4112 | 0.01802 | 0.24 |
| | Blood | >7.450-7.800* | 47 | 7.4785 | 0.02613 | 0.35 |
| | | 10-40 | 96 | 26.6 | 1.03 | 3.87 |
| | | >40-50 | 22 | 44.8 | 1.11 | 2.47 |
| | Venous | >50-100 | 14 | 68.1 | 1.60 | 2.35 |
| | Whole Blood | >100-250 | 3 | 176.7 | 2.89 | 1.63 |
| | | >250-700 | 7 | 557.3 | 10.14 | 1.82 |
| | | 10-40 | 1 | 38.5 | 0.71 | 1.84 |
| | | >40-50 | 0 | NA | NA | NA |
| PO₂<br>(mmHg) | Arterial | >50-100 | 64 | 79.8 | 1.35 | 1.70 |
| | Whole Blood | >100-250 | 70 | 150.8 | 3.67 | 2.43 |
| | | >250-700 | 4 | 388.0 | 9.55 | 2.46 |
| | | 10-40 | 2 | 38.5 | 2.89 | 7.50 |
| | | >40-50 | 18 | 45.6 | 3.76 | 8.25 |
| | Capillary Whole | >50-100* | 137 | 70.0 | 6.54 | 9.35 |
| | Blood | >100-250* | 5 | 108.2 | 21.14 | 19.54 |
| | | >250-700 | 0 | NA | NA | NA |
| | | 5.0-35.0 | 10 | 24.43 | 0.326 | 1.33 |
| | Venous | >35.0-50.0 | 85 | 45.29 | 0.721 | 1.59 |
| | Whole Blood | >50.0-62.5 | 29 | 55.85 | 0.597 | 1.07 |
| | | >62.5-130.0 | 15 | 96.53 | 1.061 | 1.10 |
| | | 5.0-35.0 | 35 | 31.13 | 0.525 | 1.69 |
| PCO₂<br>(mmHg) | Arterial | >35.0-50.0 | 87 | 44.61 | 0.747 | 1.68 |
| | Whole Blood | >50.0-62.5 | 9 | 58.33 | 1.602 | 2.75 |
| | | >62.5-130.0 | 5 | 68.62 | 0.937 | 1.37 |
| | | 5.0-35.0* | 50 | 32.11 | 1.849 | 5.76 |
| | Capillary Whole | >35.0-50.0* | 110 | 39.68 | 1.996 | 5.03 |
| | Blood | >50.0-62.5 | 1 | 60.30 | 0.000 | 0.00 |
| | | >62.5-130.0 | 1 | 66.50 | 2.404 | 3.62 |
*Results with outliers included
#### b. Linearity/assay reportable range:
#### i. Linearity
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 G3+ cartridge with the i-STAT 1 System were evaluated by preparing whole blood samples of varying analyte levels for each i-STAT test. The i-STAT pH, PO2, and PCO2 tests in
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the i-STAT G3+ 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 varving analyte levels is provided in Table 6.
| Table 6: Regression Summary for the i-STAT pH, PO2, and PCO2, Tests in the G3+ | | | | | | |
|--------------------------------------------------------------------------------|----------|------------------|-----------------|-------|-----------|--------|
| Cartridge on the i-STAT 1 Analyzer…
