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 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).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the studies that demonstrate the Abbott i-STAT G3+ cartridge with the i-STAT 1 System meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as a separate table within the document. However, they are implied by the performance characteristics demonstrated in the analytical and comparison studies. The performance reported in these studies indicates the criteria that the device successfully met for precision, linearity, detection limits, analytical specificity (interference), altitude stability, and method comparison.

Based on the provided text, the device's performance is demonstrated against these implied criteria.

Category	Specific Metric / Test	Acceptance Criteria (Implied by achieved performance)	Reported Device Performance
Analytical Performance
Precision (Aqueous)	Repeatability (SD)	Low SD/CV (e.g., pH < 0.005, PO2 < 7, PCO2 < 1.5) for various levels	Table 2: pH: 0.00251-0.00339 SD, 0.03-0.05%CV; PO2: 1.69-6.63 SD, 1.71-2.97%CV; PCO2: 0.288-0.792 SD, 0.83-2.55%CV
	Within-Laboratory (Overall) SD / %CV	Low SD/CV (e.g., pH < 0.006, PO2 < 12, PCO2 < 1.6) for various levels	Table 2: pH: 0.00291-0.00541 SD, 0.04-0.08%CV; PO2: 2.18-11.29 SD, 2.48-3.24%CV; PCO2: 0.324-1.505 SD, 1.01-2.75%CV
Multi-site/operator	Overall SD / %CV	Low SD/CV across multiple sites and operators	Table 3: pH: 0.00287-0.00589 SD, 0.04-0.09%CV; PO2: 3.31-12.94 SD, 3.17-4.91%CV; PCO2: 0.469-1.553 SD, 1.38-3.82%CV
Precision (Whole Blood)	SD / %CV (outliers excluded)	Low SD/CV for arterial, venous, and capillary whole blood across different ranges	Table 4: pH: 0.00591-0.01747 SD, 0.08-0.24%CV; PO2: 1.03-10.14 SD, 1.63-8.76%CV; PCO2: 0.326-1.709 SD, 1.07-4.64%CV
Linearity	Regression Slope, Intercept, R²	R² close to 1, slope close to 1, intercept close to 0 over the reportable range	Table 6: pH: Slope 0.988, Intercept 0.075, R² 0.9997; PO2: Slope 0.994, Intercept 0.561, R² 0.9966; PCO2: Slope 1.036, Intercept -1.223, R² 0.9983
Detection Limit	Limit of Quantitation (LoQ)	LoQ at or below the lower limit of the reportable range	Table 7: pH LoQ 6.439 (lower limit 6.500); PO2 LoQ 4 (lower limit 5); PCO2 LoQ 2.3 (lower limit 5.0)
Analytical Specificity	Interference (Yes/No)	No significant interference from listed substances at toxic/pathological concentrations	Table 8: All listed substances (Acetaminophen, Atracurium, Bilirubin, Calcium, Ethanol, Hemoglobin, Ibuprofen, Intralipid 20%, Morphine, Potassium, Sodium, Thiopental, Triglyceride) showed "No" interference for pH, PO2, and PCO2.
Altitude Stability	Correlation Coefficient (r), Slope, 95% CI	Correlation coefficient close to 1, slope close to 1, and 95% CI embracing 1 for equivalent performance at elevated altitude	Table 9: pH: r 1.00, Slope 0.98 (95% CI 0.974-0.989); PO2: r 1.00, Slope 1.03 (95% CI 1.016-1.043); PCO2: r 1.00, Slope 0.99 (95% CI 0.979-0.996). All met acceptance criteria.
Comparison Studies
Method Comparison	Passing-Bablok Regression: Slope, Intercept, r, Bias	Demonstrates substantial equivalence to the predicate device (RAPIDPoint 500/500e) with a high correlation (r close to 1), slope close to 1, intercept close to 0, and acceptable bias at medical decision levels.	Table 10 (Pooled): pH: Slope 0.98, Intercept 0.13, r 0.99, Bias at medical decision levels 0.0024-0.0042; PO2: Slope 1.05, Intercept -2.08, r 1.00, Bias -0.4 to 1.2; PCO2: Slope 1.05, Intercept -0.44, r 0.98, Bias 1.41-3.26. Table 11 (Capillary): pH: Slope 1.02, Intercept -0.12, r 0.98; PO2: Slope 1.09, Intercept -5.13, r 0.99; PCO2: Slope 1.07, Intercept -0.95, r 0.96. Table 12 (Capillary Bias): pH Bias: -0.0079 to 0.0028; PO2 Bias: -4.3 to 0.0; PCO2 Bias: 1.61 to 2.10.
Matrix Equivalence	Passing-Bablok Regression: Slope, Intercept, r	Demonstrates agreement between non-anticoagulated and anticoagulated whole blood samples for each analyte. (r close to 1, slope close to 1, intercept close to 0).	Table 13: pH: r 0.96, Slope 1.03, Intercept -0.24; PO2: r 0.99, Slope 1.01, Intercept -0.62; PCO2: r 0.97, Slope 1.02, Intercept -0.98.

Study Details

Based on the provided text, the following information can be extracted regarding the studies conducted:

1. Sample sized used for the test set and the data provenance:
- Precision (Aqueous Materials):
  - 20-day Multi-day Precision: N ranging from 80 to 85 (Table 2) per level for each analyte.
  - Multi-site and operator-to-operator precision: N = 90 (or 92 for one PO2 level) per level for each analyte (Table 3).
- Precision (Whole Blood): N ranging from 1 to 137, depending on sample type and range (Table 4 & 5). Lithium heparin whole blood specimens (arterial, venous, capillary).
- Linearity: The sample size for linearity studies is not explicitly stated in terms of 'N' values for individual tests, but it involved preparing "whole blood samples of varying analyte levels."
- Limit of Quantitation (LoQ): Not explicitly stated, but implies sufficient samples to determine LoQ using two (2) i-STAT G3+ cartridge lots.
- Interference: The study evaluated varying concentrations of 13 potentially interfering substances in whole blood samples. Not an 'N' count in the typical sense.
- Altitude: Not explicitly stated, but "whole blood samples at relevant analyte levels across the reportable range for each test" were used.
- Method Comparison:
  - Pooled Arterial, Venous, and Capillary: N = 487 for pH and PO2, N = 480 for PCO2 (Table 10).
  - Capillary only: N = 206 for pH, N = 204 for PO2, N = 199 for PCO2 (Table 11).
- Matrix Equivalence: N = 221 (Table 13).
- Data Provenance: The studies for performance characteristics appear to be laboratory-based (e.g., conducted at "one (1) site" for some precision, "three (3) sites" for multi-site precision, and "multiple point of care sites" for whole blood studies and method comparison). Given that it involved Abbott Point of Care Inc., it's likely a sponsored study. The document does not specify country of origin for the data, but the context of an FDA submission implies US-centric or international data acceptable to the FDA. The nature of these studies suggests prospective data collection for analytical validation.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the analytical performance studies (precision, linearity, LoQ, interference, altitude), "ground truth" is established by reference methods or gravimetrically prepared standards, not typically by expert consensus.
- For the Method Comparison study, the "ground truth" (or comparative method) was established by RAPIDPoint 500/500e (a predicate blood gas system), which is a device cleared for clinical use, not by human experts.
- Therefore, no information on the number or qualifications of experts used for ground truth establishment is provided or relevant in this context.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe any human adjudication method (e.g., 2+1 consensus) for establishing ground truth for the test sets. This is expected given the nature of in vitro diagnostic device validation, which relies on quantitative measurements against reference methods or predicate devices rather than human interpretation.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is primarily relevant for imaging diagnostics or other AI-assisted diagnostic tools where human interpretation is a core component. The i-STAT G3+ cartridge with the i-STAT 1 System is an in vitro diagnostic (IVD) device that provides direct quantitative measurements of blood gases and pH, without human interpretation as part of its primary function. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the entire analytical and comparative performance evaluation of the i-STAT G3+ cartridge with the i-STAT 1 System represents a standalone performance evaluation. This device is an automated system providing quantitative results, and its performance is assessed intrinsically, without direct human intervention in the result generation or initial interpretation loop, other than operating the device. The reported performance metrics are for the device's output.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For analytical performance (precision, linearity, LoQ, interference, altitude): Ground truth is established by:
  - Aqueous materials with known concentrations.
  - Reference methods and standards: Traceability to NIST SRMs (National Institute of Standards and Technology Standard Reference Materials) for pH, PO2, and PCO2 measurements. For PO2 and PCO2, this involves certified specialty medical gas tanks and tonometered aqueous standards.
  - Whole blood samples (modified for specific tests like LoQ or collected for precision ranges).
- For method comparison: Ground truth is established by comparison to a legally marketed predicate device, the RAPIDPoint 500/500e Blood Gas System.
- For matrix equivalence: Ground truth is established by comparing the candidate specimen type (non-anticoagulated whole blood) against the primary specimen type (anticoagulated whole blood) on the same device or a similar system.
7. The sample size for the training set:
- The document does not specify a "training set" size. The reported studies are for performance verification and validation of a diagnostic device, not for the development or training of an AI algorithm in the typical sense. While the device's internal algorithms would have been developed and optimized using data, that data is not described as a "training set" in this context.
8. How the ground truth for the training set was established:
- As there is no "training set" described in the context of AI algorithm training, this question is not applicable. The device's underlying technology and measurement principles are based on established electrochemical and analytical methods for blood gas analysis, supported by extensive previous engineering and development rather than contemporary AI model training.

Summary

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

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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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)

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)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/3/Picture/0 description: The image contains the Abbott logo. The logo consists of a blue abstract shape on the left and the word "Abbott" in black on the right. The abstract shape is a stylized letter "A" with rounded corners. The word "Abbott" is in a bold, sans-serif font.

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.400 College Road EastPrinceton, NJ 08540
Contact	Primary: Jacquelyn GesumariaPrincipal Specialist Regulatory AffairsPhone: +1 609-454-9384
	Secondary: Mojgan SoleimaniAssociate Director Regulatory AffairsPhone: +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 ClassificationName	RegulationNumber	Class	Panel
CHL	Electrode, Ion Specific,pH	862.1120	II	Clinical Chemistry
CHL	Electrode, Ion Specific,PCO2	862.1120	II	Clinical Chemistry
CHL	Electrode, Ion SpecificPO2	862.1120	II	Clinical Chemistry

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III. PREDICATE DEVICE

Proprietary Name RAPIDPoint 500e Blood Gas System

510(k) Number K192240

ProductCode	Device ClassificationName	RegulationNumber	Class	Panel
CHL	Electrode, Ion Specific, pH	862.1120	II	Clinical Chemistry
CHL	Electrode, Ion Specific,PCO2	862.1120	II	Clinical Chemistry
CHL	Electrode, Ion Specific PO2	862.1120	II	Clinical Chemistry

IV. DEVICE DESCRIPTION

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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,Venous and Capillary Whole Blood
Feature orCharacteristic	Candidate Device:pH, PO2 and PCO2 Tests in the i-STATG3+ cartridge with the i-STAT 1System	Predicate Device:pH, PO2 and PCO2 Tests with theRAPIDPoint 500e Blood Gas System(K192240)
Intended Use	The i-STAT G3+ cartridge with thei-STAT 1 System is intended for use inthe in vitro quantification of pH,partial pressure of oxygen (PO2), andpartial pressure of carbon dioxide(PCO2) in arterial, venous, or capillarywhole blood in point of care orclinical laboratory settings.pH, PO2, and PCO2 measurements areused in the diagnosis, monitoring,and treatment of respiratory,metabolic, and acid-basedisturbances.	The RAPIDPoint 500e Blood Gas System isintended for in vitro diagnostic use and isdesigned to provide the determination inwhole blood for the followingparameters: Partial pressure of carbon dioxide Partial pressure of oxygen pH Sodium Potassium Ionized Calcium Chloride Glucose Lactate Total Hemoglobin and fractions:FO2Hb, FCOHb, FMetHb, FHHb Neonatal Bilirubin The RAPIDPoint 500e Blood Gas System isalso intended for in vitro testing ofpleural fluid samples for the pHparameter. The pH measurement ofpleural fluid can be a clinically useful toolin the management of patients withparapneumonic effusions.The following critical value applies topleural fluid pH: pH > 7.3 is measured inuncomplicated parapneumonic effusions.
Table 1: Similarities and Differences: System (Test and Instrument): pH, PO2, and PCO2 in Arterial,Venous and Capillary Whole Blood
Feature orCharacteristic	Candidate Device:pH, PO2 and PCO2 Tests in the i-STATG3+ cartridge with the i-STAT 1System	Predicate Device:pH, PO2 and PCO2 Tests with theRAPIDPoint 500e Blood Gas System(K192240)
		All pleural fluids with a pH measurement< 7.3 are referred to as complicatedparapneumonic effusions and areexudative in nature. This test system isintended for use in point of care orlaboratory settings.
		$pCO_2, pO_2, pH$ : Measurements of bloodgases ( $pCO_2, pO_2$ ) and blood pH are usedin the diagnosis and treatment of life-threatening acid-base disturbances.
DeviceClassification	Same	Class II
Product Code	Same	CHL
RegulationNumber	Same	862.1120
ReportableRange	pHSame	pH6.500 – 7.800
	PO25 – 700 mmHg0.7 – 93.3 kPa	PO210.0 – 700.0 mmHg1.33 – 93.32 kPa
	PCO25 – 130 mmHg0.67 – 17.33 kPa	PCO25.0 – 200.0 mmHg0.66 – 26.66 kPa
Sample Type	Arterial, venous or capillary wholeblood	• Whole blood (Arterial, Venous andCapillary for all analytes)• Pleural Fluid (for pH only)
Sample Volume	95 µL	100 µL
SamplePreparation	Same	Ready to Use
SampleCollection	• Without anticoagulant• With balanced heparinanticoagulant or lithium heparinanticoagulant	With balanced heparin anticoagulant orlithium 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:pH, PO2 and PCO2 Tests in the i-STAT G3+ cartridge with the i-STAT 1 System	Predicate Device:pH, PO2 and PCO2 Tests with the RAPIDPoint 500e Blood Gas System (K192240)
Traceability	pHTraceable to NIST SRMs 186-I, 186-II, 185 and 187PO2, PCO2Traceable to NIST SRMs via commercially available certified specialty medical gas tanks	pHTraceable to NIST SRM 186 reference materials via the IFCC blood reference method.PO2, PCO2Traceable 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/Sample Stability(Time from collection to sample fill)	Without anticoagulant:	With anticoagulant:
	pH, PO2, PCO2 (arterial and venous)within 3 minutesWith anticoagulant:pH, PO2, PCO2 (arterial and venous)within 10 minutespH, PO2, PCO2 (capillary)within 3 minutes	pH, PO2, PCO2within 10 minutes
Principle of Measurement	pH, PCO2: Potentiometric measurement between active working sensor and independent reference sensor.PO2: Amperometric measurement of oxygen reduction current.	pH, PCO2: Potentiometric methodPO2: Amperometric measurement
Reagent Format	Same	Cartridge
Storage Conditions	Refrigerated at 2 to 8°C (35 to 46°F) until expiration dateRoom 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 systemRoom 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(units)	FluidLevel	N	Mean	Repeatability		Between-run		Between-day		Within-Laboratory
				SD	%CV	SD	%CV	SD	%CV	SD	%CV
pH(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(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(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(units)	FluidLevel	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
	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(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(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(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(units)	Sample Type	Sample Range	N	Mean	SD	%CV
pH(pH units)	VenousWhole 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
	ArterialWhole 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
	CapillaryWhole 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(mmHg)	VenousWhole 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
	ArterialWhole 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
	CapillaryWhole 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(mmHg)	VenousWhole 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
	ArterialWhole 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
	CapillaryWhole 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

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 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(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(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(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(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
Test	Units	Reportable Range	Range Tested	Slope	Intercept	R2
pH	pH units	6.500 – 7.800	6.4896 – 7.9054	0.988	0.075	0.9997
PO 2	mmHg	5 – 700	3.5 – 727.6	0.994	0.561	0.9966
PCO 2	mmHg	5.0 – 130.0	1.78 – 147.16	1.036	-1.223	0.9983

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 G3+ cartridge were evaluated on the i-STAT 1 analyzer using two (2) i-STAT G3+ cartridge lots, and whole blood that was altered to a low analyte level for each i-STAT test. The LoQ for each of the i-STAT tests 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 7.

Table 7: Summary of LoQ Results for Each i-STAT Test in thei-STAT G3+ Cartridge
Test(units)	Lower limit of thereportable range	LoQ
pH (pH Units)	6.500	6.439
PO2 (mmHg)	5	4
PCO2 (mmHg)	5.0	2.3

d. Analytical Specificity

i. Interference

The study was based on CLSI EP07-ED3: Interference Testing in Clinical Chemistry, Third Edition.

The interference performance of the i-STAT pH, PO2, and PCO2, tests in the i-STAT G3+ cartridge on the i-STAT 1 analyzer with the i-STAT 1 System was evaluated using whole blood samples based on CLSI EP07-ED3: Interference Testing in Clinical Chemistry, Third Edition. The effect of each substance was evaluated by comparing the performance of a control sample, spiked with blank solvent solution, with the test results from a test sample spiked with the potentially interfering substance at the toxic/pathological concentration based on CLSI EP37-ED1: Supplemental Tables for Interference Testing in Clinical Chemistry, First Edition, as applicable. A substance was identified as an interferent if the difference in means (or medians) between the control and test samples was outside of the allowed error (±Ea) for the i-STAT test. For an identified interferent, a dose

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response was performed to determine the degree of interference as a function of the substance concentration.

Table 8 contains the lists of potentially interfering substances tested and the interference results for the i-STAT G3+ cartridge.

Table 8: Potentially Interfering Substances and Test Concentrations for the i-STAT Tests in the i-STAT G3+ Cartridge
Substance 2	Substance Concentration		i-STAT Test	Interference (Yes/No)	Comments
	mmol/L (unless specified)	mg/dL (unless specified)
Acetaminophen	1.03	15.6	pHPO2PCO2	NoNoNo
Atracurium(Atracurium Besylate) 3	0.0287	3.57	pHPO2PCO2	NoNoNo
Bilirubin	0.684	40	pHPO2PCO2	NoNoNo
Calcium (Calcium Chloride)	5.0	20	pHPO2PCO2	NoNoNo
Ethanol	130	600	pHPO2PCO2	NoNoNo
Hemoglobin	10 g/L	1000	pHPO2PCO2	NoNoNo
Ibuprofen	1.06	21.9	pHPO2PCO2	NoNoNo
Intralipid 20%	N/A	2684	pHPO2PCO2	NoNoNo
Morphine (Morphine Sodium Salt)	0.0273	0.78	pHPO2PCO2	NoNoNo
Potassium (Potassium Chloride)	8	59.6	pHPO2PCO2	NoNoNo
Sodium (Sodium Chloride)	170	993.48	pHPO2PCO2	NoNoNo
Thiopental	1.66	40.2	pHPO2PCO2	NoNoNo
Table 8: Potentially Interfering Substances and Test Concentrations for the i-STATTests in the i-STAT G3+ Cartridge
	SubstanceConcentration
Substance 2	mmol/L(unlessspecified)	mg/dL(unlessspecified)	i-STATTest	Interference(Yes/No)	Comments
			PO2	No
			PCO2	No
			pH	No
Triglyceride	16.94	1500	PO2	No
			PCO2	No

2 The compound tested to evaluate the interfering substance is presented in parenthesis.

3 The test concentration for this substance is not included in CLSI guideline EP37 1st edition.

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ii. Other sensitivity studies

1) Altitude

The performance of the i-STAT pH, PO2, and PCO2 tests in the i-STAT G3+ cartridge on the i STAT 1 analyzer at an altitude of approximately 10,000 feet above sea level was evaluated using whole blood samples at relevant analyte levels across the reportable range for each test. The pH. PO2, and PCO2 results obtained from the i-STAT G3+ cartridges (candidate device) were compared to the results obtained from the i-STAT G:3+ cartridges on the i-STAT 1 analyzer (comparator device) condition. Passing-Bablok regression analyses between the 1st replicate of the candidate device (y-axis) and mean of the comparator device (x-axis) were performed based on the CLSI EP09c-ED3: Measurement Procedure Comparison and Bias Estimation using Patient Samples— Third Edition. The results of the correlation coefficient and slope met the acceptance criteria and demonstrate equivalent performance between the candidate and comparator condition at approximately 10,000 feet above sea level. The results are summarized in Table 9 below.

Table 9: Summary of Altitude Study Results
Test	Correlation Coefficient (r)		Slope
	r	95% CI	Slope	95% CI
pH	1.00	0.998 to 0.999	0.98	0.974 to 0.989
$PO_2$	1.00	0.998 to 0.999	1.03	1.016 to 1.043
$PCO_2$	1.00	0.998 to 0.999	0.99	0.979 to 0.996

B. Comparison Studies

a. Method Comparison with Comparator Device

Method comparison for arterial, venous, and capillary whole blood specimens on the i-STAT G3+ cartridge with the i-STAT 1 System was demonstrated in studies based on CLSI EP09c-ED3: Measurement Procedure Comparison and Bias Estimation Using Patient Samples – Third Edition.

Lithium heparin arterial and venous whole blood specimens collected across multiple point of care sites were evaluated using i-STAT G3+ cartridges on the i-STAT 1 analyzer against whole blood specimens tested on a RAPIDPoint 500/500e. For pH,

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PO2, and PCO2, a Passing Bablok linear regression analysis was performed using the first replicate result from the i-STAT 1 analyzer versus the singlicate result from the comparative method.

Two (2) capillary specimens collected from skin puncture with balanced heparin capillary tubes from each study subject across multiple point of care sites were evaluated and analyzed in singlicate on the i-STAT 1 analyzer against the comparative method. A Passing Bablok linear regression analysis for pH, PO2, and PCO2 was performed using the singlicate result from the i-STAT 1 analyzer versus the singlicate result of the comparative method.

The arterial, venous, and capillary data were pooled, and a Passing Bablok linear regression analysis was performed using the results from the i-STAT G3+ cartridges on the i-STAT 1 analyzer versus the comparative method results.

Method comparison results for arterial, venous, and capillary whole blood specimens are shown in Table 10. In the table, N is the number of specimens in the data set, and r is the correlation coefficient.

Table 5: Method Comparison Results for i-STAT G3+ Cartridge with i-STAT 1 System
Test(Units)	N	Slope	Intercept	r	Medical DecisionLevel	Bias at Medical DecisionLevel
pH(pH units)	487	0.98	0.13	0.99	7.30	0.0042
					7.35	0.0033
					7.45	0.0024
PO2(mmHg)	487	1.05	-2.08	1.00	30	-0.4
					45	0.4
					60	1.2
PCO2(mmHg)	480	1.05	-0.44	0.98	35.0	1.41
					45.0	1.94
					50.0	2.20
					70.0	3.26

The method comparison results for capillary whole blood specimens only are shown in Table 11.

Table 11: Results for i-STAT G3+ Cartridge with i-STAT 1 System- Native and ContrivedCapillary Specimens
Test(Units)	N	Slope	Intercept	r	SampleRange
pH(pH units)	206	1.02	-0.12	0.98	6.734 - 7.779
PO2(mmHg)	204	1.09	-5.13	0.99	9 - 680
PCO2(mmHg)	199	1.07	-0.95	0.96	5.4 - 120.0

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Table 12: Results for i-STAT G3+ Cartridge with i-STAT 1 System- Native and Contrived Capillary
Specimens Bias at Medical Decision Levels
Test(Units)	N	RangeMin	RangeMax	MedicalDecisionLevel	Bias
					Estimate	95% Cl
pH(pHunits)	190	7.315	7.576	7.300	-0.0079	(-0.0219, 0.0040)
				7.350	-0.0026	(-0.0110, 0.0050)
				7.400	0.0028	(-0.0018, 0.0077)
PO2(mmHg)	189	37	105	30	-4.3	(-8.1, -1.5)
				45	-2.2	(-4.5, -0.5)
				60	0.0	(-1.5, 0.9)
PCO2(mmHg)	190	27.7	52.4	35.0	1.61	(0.80, 2.25)
				45.0	1.94	(0.60, 3.36)
				50.0	2.10	(0.28, 4.17)

Bias at the medical decision levels for native capillary whole blood specimens only are shown in Table 12.

b. Matrix Equivalence

A matrix equivalence study was conducted to evaluate the performance of the i-STAT pH, PO2, and PCO2 tests in the i-STAT G3+ cartridge on the i-STAT 1 System using non-anticoagulated arterial and venous whole blood specimens. The study design and analysis method were based on recommendations from the Clinical and Laboratory Standards Institute (CLSI) guideline EP35: Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures, First Edition. The matrix equivalence of each test in the i-STAT G3+ cartridge was assessed by comparing arterial or venous whole blood specimens collected without anticoagulant (candidate specimen type) to samples collected with balanced heparin or lithium heparin anticoagulant (primary specimen type). Each specimen was tested in duplicate using two (2) i-STAT G3+ cartridges with two (2) i-STAT 1 analyzers. A Passing-Bablok linear regression analysis was performed using the first replicate result from the candidate (y-axis) versus the mean result from the primary specimen (x-axis). The regression analysis results are summarized in Table 13. In the table, N is the number of specimens in the data set, and r is the correlation coefficient

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Table 13: Matrix Equivalence Results
Test (units)	N	Candidate SpecimenRange	Primary SpecimenRange	r	Slope	Intercept
pH (pH units)	221	7.211-7.550	7.209-7.539	0.96	1.03	-0.24
PO2 (mmHg)	221	15-206	14-205	0.99	1.01	-0.62
PCO2 (mmHg)	221	26.1-73.8	26.0-75.2	0.97	1.02	-0.98

VIII. CONCLUSION

The results of these studies demonstrate that performance of the i-STAT pH, PO2 and PCO2 tests in the i-STAT G3+ cartridge with the i-STAT 1 System are substantially equivalent to the predicate device.

Regulation Number and Section

§ 862.1120 Blood gases (P

CO2 , PO2 ) and blood pH test system.(a)
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.(b)
Classification. Class II.