(268 days)
Not Found
No
The description focuses on electrochemical sensing and fluidics within the cartridge and analyzer, with no mention of AI/ML algorithms for data processing or interpretation. The performance studies are standard analytical and method comparison studies, not indicative of AI/ML model evaluation.
No.
The device is an in vitro diagnostic (IVD) medical device used for the quantification of sodium and potassium in blood, which aids in diagnosis and monitoring of electrolyte imbalances, but does not provide therapy.
Yes
The "Intended Use / Indications for Use" states that the device is for "in vitro quantification of sodium and potassium" and that "Potassium measurements are used in the diagnosis and cinical conditions that manifest high and low potassium levels." Additionally, the "Device Description" explicitly refers to the i-STAT 1 System as an "in vitro diagnostic (IVD) medical device."
No
The device description clearly outlines hardware components including the i-STAT CG8+ cartridge (containing sensors, fluid pack, etc.) and the i-STAT 1 analyzer (a handheld analytical device). This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "in vitro quantification of sodium and potassium in arterial or venous whole blood" and "in vitro quantification of sodium in capillary whole blood." "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Device Description: The device description clearly states, "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." It also describes the components (analyzer, cartridges, controls) which are typical of an IVD system.
- Function: The device analyzes whole blood samples to measure specific analytes (sodium and potassium) for diagnostic purposes (monitoring electrolyte imbalances, diagnosing conditions related to potassium levels). This is the core function of an IVD.
- Care Setting and User: It is intended for use by trained medical professionals in point of care or clinical laboratory settings, which are common environments for IVD use.
The provided text consistently uses the term "in vitro diagnostic" and describes the device's function and intended use in a way that aligns with the definition of an IVD.
N/A
Intended Use / Indications for Use
The i-STAT CG8+ cartridge with the i-STAT 1 System is in the in vitro quantification of sodium and potassium in arterial or venous whole blood in point of care or clinical laboratory settings.
The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of sodium in capillary whole blood in point of care or clinical laboratory settings.
Sodium measurements are used for monitoring electrolyte imbalances.
Potassium measurements are used in the diagnosis and cinical conditions that manifest high and low potassium levels.
Product codes
JGS, CEM
Device Description
The i-STAT CG8+ cartridge is used with the i-STAT 1 analyzer as part of the i-STAT 1 System and contains test reagents to measure sodium (Na) in arterial, venous or capillary whole blood and to measure potassium (K) in arterial and venous whole blood.
The i-STAT 1 System is an in vitro diagnostic (IVD) medical device intended for the quantitative determination of various clinical chemistry tests contained within i-STAT cartridges using whole blood. The i-STAT 1 System consists of a portable blood analyzer (i-STAT 1 analyzer), single-use disposable test cartridges (i-STAT cartridges), liquid quality control and calibration verification materials, and accessories (i-STAT 1 Downloader/Recharger, i-STAT Electronic Simulator and i-STAT 1 Printer). The i-STAT 1 System, including the i-STAT CG8+ cartridge, is designed for use by trained medical professionals in point of care or clinical laboratory settings and is for prescription use only.
The i-STAT CG8+ cartridge contains the required sensors, a fluid pack (calibrant pouch), a sample entry well and closure, fluid channels, waste chamber, and the necessary mechanical features for controlled fluid movement within cartridge. The i-STAT cartridge format allows all the tests in the cartridge to be performed simultaneously. All the test steps and fluid movement occur within the i-STAT CG8+cartridge. Cartridges require two to three drops of whole blood applied to the cartridge using a transfer device by the trained user before the cartridge is placed within the analyzer.
The i-STAT 1 analyzer is a handheld, in vitro diagnostic analytical device designed to run only i-STAT test cartridges. The instrument interacts with the i-STAT CG8+ cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes).
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
Precision/Reproducibility:
- 20-day Precision (Aqueous materials): Evaluated 5 levels of aqueous material using multiple analyzers and one test cartridge lot over 20 days at one site. N=80 for each level. Results for Na: %CV ranged from 0.17 to 0.19. Results for K: %CV ranged from 0.28 to 0.41.
- Multi-site and operator-to-operator precision (Aqueous materials): Performed at 3 sites using a panel of aqueous solutions (5 levels of sodium and potassium). Each level was tested once a day by 2 operators for 5 days on 6 i-STAT 1 analyzers. N ranged from 90 to 97. Overall %CV for Na ranged from 0.23 to 0.32. Overall %CV for K ranged from 0.39 to 1.05.
- Precision (Whole Blood): Assessed using duplicate test results collected across multiple point of care sites from whole blood specimens collected with lithium heparin. N for Na (venous) ranged from 17 to 99, %CV ranged from 0.24 to 0.33. N for Na (arterial) ranged from 2 to 89, %CV ranged from 0.00 to 0.31. N for Na (capillary) ranged from 3 to 95, %CV ranged from 0.34 to 0.44. N for K (venous) ranged from 19 to 135, %CV ranged from 0.50 to 1.12. N for K (arterial) ranged from 6 to 124, %CV ranged from 0.65 to 0.79.
Linearity/assay reportable range:
- Linearity: Evaluated for Na and K by preparing whole blood samples of varying analyte levels. Demonstrated linearity over the reportable range for each test. For Na, Reportable Range: 100 – 180 mmol/L, Range Tested: 91.3 – 209.8 mmol/L, Slope: 1.005, Intercept: -0.525, R2: 0.9996. For K, Reportable Range: 2.0 – 9.0 mmol/L, Range Tested: 1.79 – 10.04 mmol/L, Slope: 1.011, Intercept: 0.002, R2: 0.9994.
Detection Limit (LoQ):
- Evaluated using two i-STAT CG8+ cartridge lots and whole blood altered to low analyte levels. LoQ for Na: 92 mmol/L (lower limit of reportable range: 100 mmol/L). LoQ for K: 1.6 mmol/L (lower limit of reportable range: 2.0 mmol/L).
Analytical Specificity (Interference):
- Evaluated using whole blood samples. A substance was identified as an interferent if the difference between control and test samples was outside of the allowable error.
- Na: Decreased results > 400 mg/dL for Cholesterol. Increased results >= 2.1 mmol/L for Nithiodote (Sodium Thiosulfate).
- K: No interference reported for tested substances.
Comparison Studies:
-
Method Comparison with Comparator Device:
- K: Lithium heparin venous and arterial whole blood specimens were pooled. Comparison with i-STAT CHEM8+ via Passing-Bablok linear regression. N=340, Slope=1.00, Intercept=0.00, r=1.00. Bias at medical decision levels (3.0, 5.8, 7.5 mmol/L) was 0.00.
- Na: Venous, arterial, and capillary whole blood data were pooled. Comparison with i-STAT CHEM8+ (arterial/venous) and epoc Blood Analysis System (capillary) via Passing-Bablok linear regression. N=551, Slope=1.00, Intercept=0.00, r=0.99. Bias at medical decision levels (115, 135, 150 mmol/L) was 0.0.
- Na (Capillary only): N=209, Slope=1.00, Intercept=0.00, r=0.98, Range 101-172. Bias at medical decision levels for native capillary specimens (N=194) was 0.0 for 115, 135, and 150 mmol/L, with 95% CI (-1.0, 0.0).
-
Matrix Equivalence: Evaluated performance using non-anticoagulated venous and arterial whole blood specimens compared to samples collected with balanced heparin or lithium heparin anticoagulant. Passing-Bablok linear regression analysis.
- Na: N=295, r=0.99, Slope=1.00, Intercept=0.00.
- K: N=292, r=0.99, Slope=1.00, Intercept=0.00.
Key Metrics
Not Found (Specific metrics like Sensitivity, Specificity, PPV, NPV are not explicitly mentioned for diagnostic accuracy, but rather precision and method comparison data.)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 27, 2023
Abbott Point of Care Inc. Brian Ma, Ph.D. Principal Specialist Regulatory Affairs 400 College Road East Princeton, New Jersey 08540
Re: K230275
Trade/Device Name: i-STAT CG8+ cartridge with the i-STAT 1 System Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium Test System Regulatory Class: Class II Product Code: JGS, CEM Dated: September 25, 2023 Received: September 26, 2023
Dear Brian Ma:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
i-STAT CG8+ cartridge with the i-STAT 1 System
Indications for Use (Describe)
The i-STAT CG8+ cartridge with the i-STAT 1 System is in the in vitro quantification of sodium and potassium in arterial or venous whole blood in point of care or clinical laboratory settings.
The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of sodium in capillary whole blood in point of care or clinical laboratory settings.
Sodium measurements are used for monitoring electrolyte imbalances.
Potassium measurements are used in the diagnosis and cinical conditions that manifest high and low potassium levels.
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."
3
Image /page/3/Picture/0 description: The image contains the logo for Abbott. The logo consists of a blue, stylized letter "a" on the left, followed by the word "Abbott" in bold, black font on the right. The blue "a" symbol is a modern, geometric design, while the word "Abbott" is in a classic, serif typeface.
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: Brian Ma, PhD
Principal Specialist Regulatory Affairs
Phone: + 1 613-688-5949
Secondary: Mojgan Soleimani
Associate Director Regulatory Affairs
Phone: + 1 613-295-0932 |
| Date Prepared | October 27, 2023 |
II. DEVICE INFORMATION
| Proprietary Name | i-STAT CG8+ cartridge with the i-STAT 1 System |
|---|---|
| Common Name | Chemistry test, analyzer, handheld |
| 510(k) Number: | K230275 |
| Product Code | Device Classification
Name | Regulation
Number | Class | Panel |
|--------------|---------------------------------------|----------------------|-------|--------------------|
| JGS | Electrode, Ion
Specific, Sodium | 862.1665 | II | Clinical Chemistry |
| CEM | Electrode, Ion
Specific, Potassium | 862.1600 | II | Clinical Chemistry |
III. PREDICATE DEVICE
| Proprietary Name | i-STAT CHEM8+ cartridge with the i-STAT 1 System |
|---|---|
| 510(k) Number | K183688 |
4
| Product
Code | Device Classification
Name | Regulation
Number | Class | Panel |
|-----------------|---------------------------------------|----------------------|-------|--------------------|
| JGS | Electrode, Ion Specific,
Sodium | 862.1665 | II | Clinical Chemistry |
| CEM | Electrode, Ion Specific,
Potassium | 862.1600 | II | Clinical Chemistry |
IV. DEVICE DESCRIPTION
The i-STAT CG8+ cartridge is used with the i-STAT 1 analyzer as part of the i-STAT 1 System and contains test reagents to measure sodium (Na) in arterial, venous or capillary whole blood and to measure potassium (K) in arterial and venous whole blood.
The i-STAT 1 System is an in vitro diagnostic (IVD) medical device intended for the quantitative determination of various clinical chemistry tests contained within i-STAT cartridges using whole blood. The i-STAT 1 System consists of a portable blood analyzer (i-STAT 1 analyzer), single-use disposable test cartridges (i-STAT cartridges), liquid quality control and calibration verification materials, and accessories (i-STAT 1 Downloader/Recharger, i-STAT Electronic Simulator and i-STAT 1 Printer). The i-STAT 1 System, including the i-STAT CG8+ cartridge, is designed for use by trained medical professionals in point of care or clinical laboratory settings and is for prescription use only.
The i-STAT CG8+ cartridge contains the required sensors, a fluid pack (calibrant pouch), a sample entry well and closure, fluid channels, waste chamber, and the necessary mechanical features for controlled fluid movement within cartridge. The i-STAT cartridge format allows all the tests in the cartridge to be performed simultaneously. All the test steps and fluid movement occur within the i-STAT CG8+cartridge. Cartridges require two to three drops of whole blood applied to the cartridge using a transfer device by the trained user before the cartridge is placed within the analyzer.
The i-STAT 1 analyzer is a handheld, in vitro diagnostic analytical device designed to run only i-STAT test cartridges. The instrument interacts with the i-STAT CG8+ cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes).
V. INTENDED USE STATEMENT
The i-STAT CG8+ cartridge with the i-STAT 1 Sustem is intended for use in the in vitro quantification of sodium and potassium in arterial or venous whole blood in point of care or clinical laboratory settings.
The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of sodium in capillary whole blood in point of care or clinical laboratory settings.
Sodium measurements are used for monitoring electrolyte imbalances.
Potassium measurements are used in the diagnosis and monitoring of diseases and clinical conditions that manifest high and low potassium levels.
5
VI. SUMMARY COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| Feature or
Characteristic | Candidate Devices:
Na and K Tests in the:
i-STAT CG8+ cartridge
with the i-STAT 1 System | Predicate Device:
Na and K Tests in the:
i-STAT CHEM8+ cartridge
with the i-STAT 1 System
(K183688) |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | i-STAT CG8+ cartridge
The i-STAT CG8+ cartridge with the
i-STAT 1 System is intended for use in the
in vitro quantification of sodium and
potassium in arterial or venous whole
blood in point of care or clinical laboratory
settings.
The i-STAT CG8+ cartridge with the i-STAT
1 System is intended for use in the in vitro
quantification of sodium in capillary whole
blood in point of care or clinical laboratory
settings.
Sodium measurements are used for
monitoring electrolyte imbalances.
Potassium measurements are used in the
diagnosis and monitoring of diseases and
clinical conditions that manifest high and
low potassium levels. | i-STAT CHEM8+ cartridge
The i-STAT CHEM8+ cartridge with the
i-STAT 1 System is intended for use in the
in vitro quantification of sodium,
potassium, chloride and blood urea
nitrogen in arterial or venous whole blood
in point of care or clinical laboratory
settings.
Sodium measurements are used for
monitoring electrolyte imbalances.
Potassium measurements are used in the
diagnosis and monitoring of diseases and
clinical conditions that manifest high and
low potassium levels. |
| Device
Classification | Same | Class II |
| Product Code | Same | JGS (Na)
CEM (K) |
| Regulation
No. | Same | 862.1665 (Na)
862.1600 (K) |
| Reportable
Range | Same | Na 100 – 180 mmol/L (mEq/L)
K 2.0 - 9.0 mmol/L (mEq/L) |
6
| Feature or
Characteristic | Candidate Devices:
Na and K Tests in the:
i-STAT CG8+ cartridge
with the i-STAT 1 System | | Predicate Device:
Na and K Tests in the:
i-STAT CHEM8+ cartridge
with the i-STAT 1 System
(K183688) | | | | | | | | | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|-------------------------------------------------------------------------|
| Sample Type | Na | Arterial, venous or capillary
whole blood
Arterial or venous whole
blood | Arterial and venous whole blood | | | | | | | | | |
| Sample
Volume | Same | | 95 µL | | | | | | | | | |
| Sample
Preparation | Same | | Ready to Use | | | | | | | | | |
| Sample
collection | | Na K Without
anticoagulant Arterial or venous With balanced
heparin
anticoagulant or
lithium heparin
anticoagulant Arterial,
venous,
or
capillary Arterial
or venous | | | | | | | | | | With balanced heparin anticoagulant or
lithium heparin anticoagulant |
| Traceability | Same | | Na, K NIST SRM956 | | | | | | | | | |
| Calibration | Same | | 1-point on-board contained within
cartridge | | | | | | | | | |
| Principle of
Measurement | Same | | Na, K: Ion-selective electrode
potentiometry | | | | | | | | | |
| Reagent
Format | Same | | Cartridge | | | | | | | | | |
| Reagent
Storage and
Stability | Refrigerated at 2-8°C (35-46°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
expiration date
Room Temperature at 18-30°C (64-86°F)
for 14 days | | | | | | | | | |
| Analyzer Type | Same | | Handheld | | | | | | | | | |
7
VII. PERFORMANCE CHARACTERISTICS
A. Analytical Performance
a. Precision/Reproducibility:
i. Precision 20 days (Aqueous materials)
The precision of the i-STAT Sodium (Na) and Potassium (K) tests in the i-STAT CG8+ cartridge on the i-STAT 1 System was evaluated using five (5) levels of aqueous material. This 20-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 20 days at one site. Repeatability, between-run, between-day, and within-laboratory precision were estimated for each level. The results of the 20-day precision study for the i-STAT CG8+ cartridge on the i-STAT 1 System are shown in Table 2.
| Table 2: Results of 20-Day Precision of the i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Test | |||||||||||
| (units) | Fluid | ||||||||||
| Level | N | Mean | Repeatability | Between-run | Between-day | Within- | |||||
| Laboratory | |||||||||||
| SD | %CV | SD | %CV | SD | %CV | SD | %CV | ||||
| CV L1 | 80 | 99.3 | 0.17 | 0.17 | 0.09 | 0.09 | 0.05 | 0.05 | 0.19 | 0.20 | |
| Na | |||||||||||
| (mmol/L) | CV L2 | 80 | 121.4 | 0.20 | 0.16 | 0.06 | 0.05 | 0.05 | 0.04 | 0.22 | 0.18 |
| CV L3 | 80 | 134.8 | 0.22 | 0.16 | 0.06 | 0.05 | 0.06 | 0.05 | 0.23 | 0.17 | |
| CV L4 | 80 | 161.3 | 0.27 | 0.16 | 0.12 | 0.07 | 0.07 | 0.04 | 0.30 | 0.19 | |
| CV L5 | 80 | 181.1 | 0.32 | 0.18 | 0.12 | 0.06 | 0.09 | 0.05 | 0.35 | 0.19 | |
| K | |||||||||||
| (mmol/L) | CV L1 | 80 | 2.09 | 0.008 | 0.37 | 0.003 | 0.16 | 0.001 | 0.04 | 0.009 | 0.41 |
| CV L2 | 80 | 2.87 | 0.007 | 0.25 | 0.002 | 0.09 | 0.002 | 0.08 | 0.008 | 0.28 | |
| CV L3 | 80 | 3.76 | 0.012 | 0.31 | 0.004 | 0.10 | 0.006 | 0.15 | 0.014 | 0.36 | |
| CV L4 | 80 | 6.41 | 0.021 | 0.33 | 0.008 | 0.12 | 0.012 | 0.18 | 0.025 | 0.39 | |
| CV L5 | 80 | 7.99 | 0.027 | 0.33 | 0.010 | 0.13 | 0.014 | 0.18 | 0.032 | 0.40 |
ii. Multi-site and operator-to-operator precision (Aqueous materials)
Multi-day precision testing was performed at three (3) sites using a panel of aqueous solutions containing five (5) levels of sodium and potassium. At each site, each level was tested once a day by two (2) operators for five (5) days on six (6) i-STAT 1 analyzers using i-STAT CG8+ cartridges. Within-run, between-day, 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 the i-STAT CG8+ 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 | ||||
| Na | |||||||||||||||
| (mmol/L) | CV L1 | 91 | 100.0 | 0.29 | 0.29 | 0.12 | 0.12 | 0.08 | 0.08 | 0.32 | 0.32 | 0.00 | 0.00 | 0.32 | 0.32 |
| CV L2 | 90 | 121.9 | 0.28 | 0.23 | 0.04 | 0.04 | 0.00 | 0.00 | 0.29 | 0.23 | 0.00 | 0.00 | 0.29 | 0.23 | |
| CV L3 | 97 | 134.9 | 0.34 | 0.25 | 0.00 | 0.00 | 0.06 | 0.04 | 0.34 | 0.25 | 0.03 | 0.02 | 0.34 | 0.26 | |
| CV L4 | 90 | 161.2 | 0.46 | 0.29 | 0.00 | 0.00 | 0.00 | 0.00 | 0.46 | 0.29 | 0.21 | 0.13 | 0.51 | 0.32 | |
| CV L5 | 90 | 181.1 | 0.37 | 0.21 | 0.04 | 0.02 | 0.00 | 0.00 | 0.38 | 0.21 | 0.18 | 0.10 | 0.42 | 0.23 | |
| K | |||||||||||||||
| (mmol/L) | CV L1 | 91 | 2.10 | 0.010 | 0.50 | 0.000 | 0.01 | 0.000 | 0.00 | 0.01 | 0.50 | 0.000 | 0.01 | 0.010 | 0.50 |
| CV L2 | 90 | 2.81 | 0.026 | 0.91 | 0.000 | 0.00 | 0.012 | 0.44 | 0.028 | 1.01 | 0.008 | 0.28 | 0.029 | 1.05 | |
| CV L3 | 97 | 3.70 | 0.014 | 0.38 | 0.000 | 0.00 | 0.003 | 0.09 | 0.014 | 0.39 | 0.000 | 0.00 | 0.014 | 0.39 | |
| CV L4 | 90 | 6.32 | 0.044 | 0.70 | 0.000 | 0.00 | 0.005 | 0.08 | 0.044 | 0.70 | 0.008 | 0.12 | 0.045 | 0.71 | |
| CV L5 | 90 | 7.89 | 0.038 | 0.48 | 0.000 | 0.00 | 0.006 | 0.07 | 0.038 | 0.48 | 0.011 | 0.14 | 0.040 | 0.50 |
8
iii. Precision (Whole Blood)
Whole blood precision of the i-STAT Sodium and Potassium tests in the i-STAT CG8+ cartridge on the i-STAT 1 System was evaluated using whole blood specimens 1 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.
| cartridge on the i-STAT 1 Analyzer | ||||||
|---|---|---|---|---|---|---|
| Test | ||||||
| (units) | Sample Type | Sample Range | N | Mean | SD | %CV |
| Na | ||||||
| (mmol/L) | Venous Whole Blood | 100-130 | 17 | 122.6 | 0.30 | 0.24 |
| Venous Whole Blood | >130-140 | 99 | 137.5 | 0.45 | 0.33 | |
| Venous Whole Blood | >140-180 | 67 | 146.2 | 0.43 | 0.30 | |
| Na | ||||||
| (mmol/L) | Arterial Whole Blood | 100-130 | 2 | 128.0 | 0.00 | 0.00 |
| Arterial Whole Blood | >130-140 | 89 | 137.4 | 0.42 | 0.31 | |
| Arterial Whole Blood | >140-180 | 62 | 142.9 | 0.37 | 0.26 | |
| Na | ||||||
| (mmol/L) | Capillary Whole Blood | 100-130 | 3 | 120.8 | 0.41 | 0.34 |
| Capillary Whole Blood | >130-140 | 56 | 138.1 | 0.61 | 0.44 | |
| Capillary Whole Blood | >140-180 | 95 | 142.4 | 0.62 | 0.44 | |
| K | ||||||
| (mmol/L) | Venous Whole Blood | 2.0-3.5 | 27 | 3.22 | 0.036 | 1.12 |
| Venous Whole Blood | >3.5-5.0 | 135 | 4.12 | 0.038 | 0.92 | |
| Venous Whole Blood | >5.0-9.0 | 19 | 6.49 | 0.032 | 0.50 | |
| K | ||||||
| (mmol/L) | Arterial Whole Blood | 2.0-3.5 | 23 | 3.21 | 0.021 | 0.65 |
| Arterial Whole Blood | >3.5-5.0 | 124 | 4.11 | 0.032 | 0.79 | |
| Arterial Whole Blood | >5.0-9.0 | 6 | 5.67 | 0.041 | 0.72 | |
Table 4: Whole Blood Precision of arterial, venous, and capillary whole blood for i-STAT CG8+
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 Sodium and Potassium tests in the i-STAT CG8+ cartridge with the i-STAT 1 System was evaluated by preparing whole blood samples of varying analyte levels for each i-STAT test. The i-STAT Sodium and Potassium tests in the i-STAT CG8+ cartridge demonstrated linearity over the reportable range for each i-STAT test. Regression summary of the response for each i-STAT test versus the concentration of the whole blood samples of varying analyte levels is provided in Table 5.
| Table 5: Regression Summary for the i-STAT Na and K tests in the i-STAT CG8+ Cartridge on
| the i-STAT 1 Analyzer | ||||||
|---|---|---|---|---|---|---|
| Test | Units | Reportable Range | Range Tested | Slope | Intercept | R2 |
| Na | mmol/L | 100 – 180 | 91.3 – 209.8 | 1.005 | -0.525 | 0.9996 |
| K | mmol/L | 2.0 – 9.0 | 1.79 – 10.04 | 1.011 | 0.002 | 0.9994 |
1 The capillary whole blood clinical precision study design involved the performance of two individual fingersticks, collected independently by two operators into two separate capillary tubes and tested on two (2) i-STAT CG8+ cartridges.
9
c. Detection Limit
Limit of Quantitation (LoQ) i.
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 Sodium and Potassium tests in the i-STAT CG8+ cartridge was evaluated on the i-STAT 1 analyzer using two (2) i-STAT CG8+ cartridge lots and whole blood that was altered to a low analyte level for each i-STAT test. The LoQ for the i-STAT Sodium and Potassium tests in the i-STAT CG8+ cartridge was determined to be at or below the lower limit of the reportable range for each of the i-STAT tests as shown in Table 6.
| Table 6: Summary of LoQ Results for i-STAT Tests in the i-STAT CG8+ Cartridge | ||
|---|---|---|
| Test (units) | Lower limit of the reportable range | Determined LoQ |
| Na (mmol/L) | 100 | 92 |
| K (mmol/L) | 2.0 | 1.6 |
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 Sodium and Potassium tests in the i-STAT CG8+ 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 between the control and test samples was outside of the allowable error (±Ea) for the i-STAT test. For an identified interferent, a dose-response was performed to determine the degree of interference as a function of the substance concentration.
Table 7 contains the list of potentially interfering substances tested and the interference results for the i-STAT CG8+ cartridge.
| Table 7: Potentially Interfering Substances and Test Concentrations for the i-STAT Sodium and
| Potassium tests in the i-STAT CG8+ Cartridge | |||||
|---|---|---|---|---|---|
| Substance 2 | Test Concentration | i-STAT Test | Interference (Yes/No) | Comments | |
| mmol/L | |||||
| (unless specified) | mg/dL | ||||
| (unless specified) | |||||
| Acetaminophen | 1.03 | 15.6 | Na | No | |
| K | No | ||||
| Acetyl Cysteine | 0.92 | 15 | Na | No | |
| Table 7: Potentially Interfering Substances and Test Concentrations for the i-STAT Sodium and Potassium tests in the i-STAT CG8+ Cartridge | |||||
| Substance 2 | Test Concentration | i-STAT Test | Interference (Yes/No) | Comments | |
| mmol/L (unless specified) | mg/dL (unless specified) | ||||
| (N-Acetyl-L-Cysteine) | K | No | |||
| Acetylsalicylic Acid | 0.167 | 3.0 | Na | No | |
| Ammonium (Ammonium Chloride) 3 | 2.0 | 10.7 | Na | No | |
| K | No | ||||
| Ascorbic Acid (L-Ascorbic Acid) | 0.298 | 5.25 | Na | No | |
| K | No | ||||
| Benzalkonium (Benzalkonium Chloride) 3 | 0.03 | 1.13 | K | No | |
| β-Hydroxybutyric Acid 3 | 6.0 | 62.46 | Na | No | |
| K | No | ||||
| Bilirubin | 0.684 | 40 | Na | No | |
| K | No | ||||
| Bromide 3 (Lithium Bromide) | 2.5 | 21.7 | Na | No | |
| K | No | ||||
| 37.5 | 325.7 | Na | No | Use Another Method | |
| K | No | ||||
| Calcium (Calcium Chloride) | 5.0 | 20 | Na | No | |
| K | No | ||||
| Chloride (Lithium Chloride) | 3.2 | 13.6 | Na | No | |
| K | No | ||||
| Cholesterol | 11.0 | 425 | Na | Yes | Decreased results > 400 mg/dL |
| K | No | ||||
| Hemoglobin | 10 g/L | 1000 | Na | No | |
| K | No | ||||
| Heparin (Sodium Heparin) | 3.30 U/mL | 330 U/dL | Na | No | |
| Ibuprofen | 1.06 | 21.9 | Na | No | |
| Intralipid 20% | N/A | 2395 | Na | No | |
| 3216 | K | No | |||
| Lactate (Lithium Lactate) | 10 | 90 | Na | No | |
| K | No | ||||
| Magnesium (Magnesium Chloride) | 4.1 | 10 | Na | No | |
| K | No | ||||
| Nithiodote (Sodium Thiosulfate) 3 | 16.7 | 264.04 | Na | Yes | Increased results ≥ 2.1 mmol/L |
| K | No | ||||
| Salicylate (Lithium Salicylate) | 0.207 | 2.86 | Na | No | |
| K | No | ||||
| Triglyceride | 16.94 | 1500 | Na | No | |
| K | No | ||||
| Uric Acid | 1.4 | 23.5 | Na | No |
2 The compound tested to evaluate the interfering substance is presented in parenthesis.
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Table 7: Potentially Interfering Substances and Test Concentrations for the i-STAT Sodium and
B. Comparison Studies
3 The test concentration for this substance is not included in CLSI guideline EP37 1st edition.
11
a. Method Comparison with Comparator Device
Method comparison for the i-STAT CG8+ 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 venous and arterial whole blood specimens collected across multiple point of care sites were evaluated using i-STAT CG8+ cartridges on the i-STAT 1 analyzer against whole blood specimens tested on a comparative method. For sodium and potassium, the first replicate result from the i-STAT 1 analyzer was compared to the mean result from the comparative method.
Two (2) capillary whole blood 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 sodium was performed using the singlicate result from the i-STAT 1 analyzer versus the singlicate result of the comparative method.
The venous and arterial data were pooled, and a Passing-Bablok linear regression analysis was performed using the i STAT Potassium results from the i STAT CG8+ cartridges on the i-STAT 1 analyzer versus the comparative method results. Method comparison results comparing the i-STAT Potassium performance on the i-STAT 1 analyzer to comparative methods for arterial and venous are as shown in Table 8. In the table. N is the number of specimens in the data set, and r is the correlation coefficient.
| Table 8: Method Comparison Results for the i-STAT K test in the i-STAT CG8+ Cartridge with i-STAT 1
| System | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Test | Comparative | ||||||||
| Method | N | Slope | Intercept | r | Xmin | Xmax | Medical | ||
| Decision | |||||||||
| Level | Bias at | ||||||||
| Medical | |||||||||
| Decision | |||||||||
| Level | |||||||||
| (units) | Arterial/ | ||||||||
| Venous | |||||||||
| K | |||||||||
| (mmol/L) | i-STAT CHEM8+ | 340 | 1.00 | 0.00 | 1.00 | 2.4 | 8.8 | 3.0 | |
| 5.8 | |||||||||
| 7.5 | 0.00 | ||||||||
| 0.00 | |||||||||
| 0.00 |
The venous, arterial, and capillary whole blood data were pooled, and a Passing-Bablok linear regression analysis was performed using the i-STAT Sodium results from the i-STAT CG8+ cartridges on the i-STAT 1 analyzer versus the comparative method results.
Method comparison results comparing the i-STAT Sodium performance on the i-STAT 1 analyzer to the comparative method for arterial, venous, and capillary whole blood specimens are shown in Table 9. In the table, N is the number of specimens in the data set, and r is the correlation coefficient.
12
| Table 9: Method Comparison Results for for the i-STAT Na test in the i-STAT CG8+ Cartridge with i-
| STAT 1 System | ||||||||
|---|---|---|---|---|---|---|---|---|
| Comparative Method | Medical | Bias at | ||||||
| Test | ||||||||
| (units) | Arterial/ | |||||||
| Venous | Capillary | N | Slope | Intercept | r | Decision | ||
| Level | Medical | |||||||
| Decision | ||||||||
| Level | ||||||||
| Na | ||||||||
| (mmol/L) | i-STAT | |||||||
| CHEM8+ | epoc Blood | |||||||
| Analysis | ||||||||
| System | 551 | 1.00 | 0.00 | 0.99 | 115 | 0.0 | ||
| 135 | 0.0 | |||||||
| 150 | 0.0 | |||||||
The method comparison results for capillary whole blood specimens only for the i-STAT Sodium test are shown in Table 10.
| Table 10: Results for i-STAT CG8+ Cartridge with i-STAT 1 System – Native and Contrived
| Capillary Specimens | ||||||
|---|---|---|---|---|---|---|
| Test | ||||||
| (units) | N | Slope | Intercept | r | Range | |
| Na | ||||||
| (mmol/L) | 209 | 1.00 | 0.00 | 0.98 | 101 - 172 | |
Bias at the medical decision levels for native capillary whole blood specimens only for the i-STAT Sodium test are shown in Table 11.
| Table 11: Results for i-STAT CG8+ Cartridge with i-STAT 1 System - Native Capillary Specimens
| Bias at Medical Decision Levels | |||||
|---|---|---|---|---|---|
| Test | |||||
| (units) | N | Medical Decision | |||
| Level | Bias | ||||
| Estimate 95% CI | |||||
| Na | |||||
| (mmol/L) | 194 | 115 | 0.0 (-1.0, 0.0) | ||
| 135 | 0.0 (-1.0, 0.0) | ||||
| 150 | 0.0 (-1.0, 0.0) | ||||
b. Matrix Equivalence
A matrix equivalence study was conducted to evaluate the performance of the i-STAT Sodium and Potassium tests in the i-STAT CG8+ cartridge on the i-STAT 1 System
13
using non-anticoagulated venous and arterial 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, 1st ed. The matrix equivalence of each test in the i-STAT CG8+ 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 CG8+ 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 12. In the table, N is the number of specimens in the data set, and r is the correlation coefficient.
| Table 12: Matrix Equivalence Results | ||||||
|---|---|---|---|---|---|---|
| Test (units) | N | Candidate | ||||
| Specimen Range | Primary Specimen | |||||
| Range | r | Slope | Intercept | |||
| Na (mmol/L) | 295 | 102-178 | 102-178 | 0.99 | 1.00 | 0.00 |
| K (mmol/L) | 292 | 2.4-8.7 | 2.4-8.7 | 0.99 | 1.00 | 0.00 |
VIII. CONCLUSION
The results of these studies demonstrate that performance of the i-STAT Sodium and Potassium tests in the i-STAT CG8+ cartridge with the i-STAT 1 System is substantially equivalent to the predicate device.