(266 days)
Not Found
No
The summary describes a standard in vitro diagnostic device that measures blood gas parameters using electrochemical sensors. There is no mention of AI, ML, or any computational methods beyond basic signal processing and quantitative analysis. The performance studies focus on analytical and method comparison, not on the evaluation of an AI/ML algorithm.
No.
The device is an in vitro diagnostic (IVD) medical device used for quantifying blood gas parameters, which assists in diagnosis, monitoring, and treatment, but it does not directly administer therapy to a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the measurements are "used in the diagnosis, monitoring, and treatment of respiratory, metabolic, and acid-base disturbances." Additionally, the "Device Description" section identifies it as an "in vitro diagnostic (IVD) medical device."
No
The device description clearly outlines hardware components including a cartridge with sensors, fluid pack, and channels, and an analyzer that interacts with the cartridge. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states the device is for "in vitro quantification of pH, partial pressure of oxygen (PO2), and partial pressure of carbon dioxide (PCO2) in arterial, venous, or capillary whole blood". This clearly indicates testing is performed outside of the body using biological samples.
- Device Description: The "Device Description" section explicitly states, "The i-STAT 1 System is an in vitro diagnostic (IVD) medical device". It also describes the components and how they are used to perform tests on whole blood.
- Performance Studies: The "Summary of Performance Studies" describes analytical and comparison studies performed on whole blood samples, which is characteristic of IVD device validation.
The information provided strongly supports the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes
CHL
Device Description
The i-STAT G3+ cartridge is used with the i-STAT 1 analyzer as part of the i-STAT 1 System 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professionals in point of care or clinical laboratory settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance
- Precision/Reproducibility:
- 20 days (Aqueous Materials): Evaluated precision using five (5) levels of aqueous materials based on CLSI document EP05-A3. The study involved 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.
- pH: Within-Laboratory SD ranged from 0.00291 to 0.00541 pH units.
- PO2: Within-Laboratory SD ranged from 2.18 to 11.29 mmHg.
- PCO2: Within-Laboratory SD ranged from 0.324 to 1.505 mmHg.
- Multi-site and operator-to-operator precision (Aqueous materials): Multi-day precision testing at three (3) sites using a panel of five (5) levels of aqueous material. Each level was tested once per day by two (2) operators over six (6) days on six (6) i-STAT 1 analyzers using one (1) lot of i-STAT G3+ cartridges. Within-run, between-day, between-operator, and within-site (total) variance components were calculated.
- pH: Overall SD ranged from 0.00287 to 0.00589 pH units.
- PO2: Overall SD ranged from 3.31 to 12.94 mmHg.
- PCO2: Overall SD ranged from 0.469 to 1.553 mmHg.
- Whole Blood Precision: Assessed using arterial, venous, and capillary whole blood specimens collected with lithium heparin across multiple point-of-care sites.
- pH (Arterial): SD ranged from 0.00701 to 0.00913 pH units (outliers excluded).
- PO2 (Arterial): SD ranged from 0.71 to 9.55 mmHg (outliers excluded).
- PCO2 (Arterial): SD ranged from 0.525 to 1.602 mmHg (outliers excluded).
- Capillary whole blood precision involved two individual fingersticks by two operators and testing on two cartridges.
- 20 days (Aqueous Materials): Evaluated precision using five (5) levels of aqueous materials based on CLSI document EP05-A3. The study involved 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.
- Linearity/assay reportable range:
- Linearity: Evaluated for pH, PO2, and PCO2 tests in the i-STAT G3+ cartridge with the i-STAT 1 System by preparing whole blood samples of varying analyte levels. Demonstrated linearity over the reportable range.
- pH: Slope = 0.988, Intercept = 0.075, R2 = 0.9997 (Range Tested: 6.4896 – 7.9054 pH units).
- PO2: Slope = 0.994, Intercept = 0.561, R2 = 0.9966 (Range Tested: 3.5 – 727.6 mmHg).
- PCO2: Slope = 1.036, Intercept = -1.223, R2 = 0.9983 (Range Tested: 1.78 – 147.16 mmHg).
- Linearity: Evaluated for pH, PO2, and PCO2 tests in the i-STAT G3+ cartridge with the i-STAT 1 System by preparing whole blood samples of varying analyte levels. Demonstrated linearity over the reportable range.
- Detection Limit
- Limit of Quantitation (LoQ): Evaluated based on CLSI EP17-A2. Determined to be at or below the lower limit of the reportable range using two (2) cartridge lots and altered whole blood.
- pH: LoQ = 6.439 (Reportable Range Lower Limit: 6.500).
- PO2: LoQ = 4 (Reportable Range Lower Limit: 5).
- PCO2: LoQ = 2.3 (Reportable Range Lower Limit: 5.0).
- Limit of Quantitation (LoQ): Evaluated based on CLSI EP17-A2. Determined to be at or below the lower limit of the reportable range using two (2) cartridge lots and altered whole blood.
- Analytical Specificity
- Interference: Evaluated based on CLSI EP07-ED3 using whole blood samples for various potentially interfering substances. A dose-response was performed for identified interferents. All tested substances (Acetaminophen, Atracurium, Bilirubin, Calcium, Ethanol, Hemoglobin, Ibuprofen, Intralipid 20%, Morphine, Potassium, Sodium, Thiopental, Triglyceride) showed no interference at specified concentrations for pH, PO2, and PCO2.
- Other sensitivity studies
- Altitude: Performance at approximately 10,000 feet above sea level evaluated using whole blood samples. Results from candidate device (i-STAT G3+) compared to comparator device (i-STAT G3+ on i-STAT 1 analyzer) using Passing-Bablok regression.
- pH: Correlation Coefficient (r) = 1.00, Slope = 0.98.
- PO2: Correlation Coefficient (r) = 1.00, Slope = 1.03.
- PCO2: Correlation Coefficient (r) = 1.00, Slope = 0.99.
- Altitude: Performance at approximately 10,000 feet above sea level evaluated using whole blood samples. Results from candidate device (i-STAT G3+) compared to comparator device (i-STAT G3+ on i-STAT 1 analyzer) using Passing-Bablok regression.
Comparison Studies
- Method Comparison with Comparator Device: Studies based on CLSI EP09c-ED3.
- Arterial, Venous, and Capillary Whole Blood: Lithium heparin arterial and venous whole blood specimens collected across multiple point of care sites were evaluated against a RAPIDPoint 500/500e. Two capillary specimens were also evaluated. Pooled data analyzed using Passing-Bablok linear regression.
- pH: N=487, Slope=0.98, Intercept=0.13, r=0.99. Bias at medical decision levels: 0.0042 (7.30), 0.0033 (7.35), 0.0024 (7.45).
- PO2: N=487, Slope=1.05, Intercept=-2.08, r=1.00. Bias at medical decision levels: -0.4 (30), 0.4 (45), 1.2 (60).
- PCO2: N=480, Slope=1.05, Intercept=-0.44, r=0.98. Bias at medical decision levels: 1.41 (35.0), 1.94 (45.0), 2.20 (50.0), 3.26 (70.0).
- Capillary Whole Blood Specimens only (Native and Contrived):
- pH: N=206, Slope=1.02, Intercept=-0.12, r=0.98.
- PO2: N=204, Slope=1.09, Intercept=-5.13, r=0.99.
- PCO2: N=199, Slope=1.07, Intercept=-0.95, r=0.96.
- Bias at Medical Decision Levels (Native Capillary Specimens):
- pH: Bias at 7.300 = -0.0079, at 7.350 = -0.0026, at 7.400 = 0.0028.
- PO2: Bias at 30 = -4.3, at 45 = -2.2, at 60 = 0.0.
- PCO2: Bias at 35.0 = 1.61, at 45.0 = 1.94, at 50.0 = 2.10.
- Arterial, Venous, and Capillary Whole Blood: Lithium heparin arterial and venous whole blood specimens collected across multiple point of care sites were evaluated against a RAPIDPoint 500/500e. Two capillary specimens were also evaluated. Pooled data analyzed using Passing-Bablok linear regression.
- Matrix Equivalence: Conducted to evaluate performance using non-anticoagulated arterial and venous whole blood specimens, comparing them to samples collected with balanced heparin or lithium heparin anticoagulant (primary specimen type). Each specimen tested in duplicate using two cartridges with two analyzers. Passing-Bablok linear regression analysis performed.
- pH: N=221, Slope=1.03, Intercept=-0.24, r=0.96.
- PO2: N=221, Slope=1.01, Intercept=-0.62, r=0.99.
- PCO2: N=221, Slope=1.02, Intercept=-0.98, r=0.97.
Key Results: The 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Precision metrics (SD, %CV) and regression analysis metrics (Slope, Intercept, R2, r) are provided.
Predicate Device(s):
Reference Device(s):
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
- 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)
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) | |
|---|---|
| ☑ 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 East
Princeton, NJ 08540 |
|---------------|---------------------------------------------------------------------------------------------------|
| Contact | Primary: Jacquelyn Gesumaria
Principal Specialist Regulatory Affairs
Phone: +1 609-454-9384 |
| | Secondary: Mojgan Soleimani
Associate Director Regulatory Affairs
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
Name | Regulation
Number | 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 |
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III. PREDICATE DEVICE
Proprietary Name RAPIDPoint 500e Blood Gas System
510(k) Number K192240
| Product
Code | Device Classification
Name | Regulation
Number | 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
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,
| 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) | ||
| 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. | The RAPIDPoint 500e Blood Gas System is
intended for in vitro diagnostic use and is
designed to provide the determination in
whole blood for the following
parameters: 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 is
also intended for in vitro testing of
pleural fluid samples for the pH
parameter. The pH measurement of
pleural fluid can be a clinically useful tool
in the management of patients with
parapneumonic effusions.
The following critical value applies to
pleural fluid pH: pH > 7.3 is measured in
uncomplicated parapneumonic effusions. |
| 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) |
| | | All pleural fluids with a pH measurement
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 | pH
Traceable to NIST SRMs 186-I, 186-II, 185 and 187
PO2, PCO2
Traceable to NIST SRMs via commercially available certified specialty medical gas tanks | pH
Traceable to NIST SRM 186 reference materials via the IFCC blood reference method.
PO2, PCO2
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/
Sample Stability
(Time from collection to sample fill) | Without anticoagulant: | With anticoagulant: |
| | pH, PO2, PCO2 (arterial and venous)
within 3 minutes
With anticoagulant:
pH, PO2, PCO2 (arterial and venous)
within 10 minutes
pH, PO2, PCO2 (capillary)
within 3 minutes | pH, PO2, PCO2
within 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 method
PO2: Amperometric measurement |
| Reagent Format | Same | Cartridge |
| Storage Conditions | Refrigerated at 2 to 8°C (35 to 46°F) until expiration date
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
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
(units) | Fluid
Level | 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 | |
|---|---|
| ---------------------------------------------------------------------------- | -- |
9
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) | Fluid | ||||||||||||||
| 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 | ||||
| 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 |
10
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) | Venous | |||||
| 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 | ||||||
| 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 | ||||||
| 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 | ||||||
| (mmHg) | Venous | |||||
| 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 | ||||||
| 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 | ||||||
| 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 | ||||||
| (mmHg) | Venous | |||||
| 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 | ||||||
| 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 | ||||||
| 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
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.
11
| 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
12
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 the
| i-STAT G3+ Cartridge | ||
|---|---|---|
| Test | ||
| (units) | Lower limit of the | |
| reportable 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
13
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 | pH | |||
| PO2 | ||||||
| PCO2 | No | |||||
| No | ||||||
| No | ||||||
| Atracurium | ||||||
| (Atracurium Besylate) 3 | 0.0287 | 3.57 | pH | |||
| PO2 | ||||||
| PCO2 | No | |||||
| No | ||||||
| No | ||||||
| Bilirubin | 0.684 | 40 | pH | |||
| PO2 | ||||||
| PCO2 | No | |||||
| No | ||||||
| No | ||||||
| Calcium (Calcium Chloride) | 5.0 | 20 | pH | |||
| PO2 | ||||||
| PCO2 | No | |||||
| No | ||||||
| No | ||||||
| Ethanol | 130 | 600 | pH | |||
| PO2 | ||||||
| PCO2 | No | |||||
| No | ||||||
| No | ||||||
| Hemoglobin | 10 g/L | 1000 | pH | |||
| PO2 | ||||||
| PCO2 | No | |||||
| No | ||||||
| No | ||||||
| Ibuprofen | 1.06 | 21.9 | pH | |||
| PO2 | ||||||
| PCO2 | No | |||||
| No | ||||||
| No | ||||||
| Intralipid 20% | N/A | 2684 | pH | |||
| PO2 | ||||||
| PCO2 | No | |||||
| No | ||||||
| No | ||||||
| Morphine (Morphine Sodium Salt) | 0.0273 | 0.78 | pH | |||
| PO2 | ||||||
| PCO2 | No | |||||
| No | ||||||
| No | ||||||
| Potassium (Potassium Chloride) | 8 | 59.6 | pH | |||
| PO2 | ||||||
| PCO2 | No | |||||
| No | ||||||
| No | ||||||
| Sodium (Sodium Chloride) | 170 | 993.48 | pH | |||
| PO2 | ||||||
| PCO2 | No | |||||
| No | ||||||
| No | ||||||
| Thiopental | 1.66 | 40.2 | pH | |||
| PO2 | ||||||
| PCO2 | No | |||||
| No | ||||||
| No | ||||||
| Table 8: Potentially Interfering Substances and Test Concentrations for the i-STAT | ||||||
| Tests in the i-STAT G3+ Cartridge | ||||||
| Substance | ||||||
| Concentration | ||||||
| Substance 2 | mmol/L | |||||
| (unless | ||||||
| specified) | mg/dL | |||||
| (unless | ||||||
| specified) | i-STAT | |||||
| Test | 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.
14
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,
15
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 Decision | |
| Level | Bias at Medical Decision | |||||
| Level | ||||||
| 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 Contrived
| Capillary Specimens | |||||||
|---|---|---|---|---|---|---|---|
| Test | |||||||
| (Units) | N | Slope | Intercept | r | Sample | ||
| Range | |||||||
| 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 |
16
| 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 | Range | ||||||
| Min | Range | |||||||
| Max | Medical | |||||||
| Decision | ||||||||
| Level | Bias | |||||||
| Estimate | 95% Cl | |||||||
| pH | ||||||||
| (pH | ||||||||
| units) | 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
17
| Table 13: Matrix Equivalence Results | ||||||||
|---|---|---|---|---|---|---|---|---|
| Test (units) | N | Candidate Specimen | ||||||
| Range | Primary Specimen | |||||||
| Range | 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.