(269 days)
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No
The summary describes a standard in vitro diagnostic system based on chemical reactions and sensor technology, with no mention of AI or ML in the device description, performance studies, or key metrics.
No.
This device is an in vitro diagnostic (IVD) device used for quantifying total carbon dioxide in blood, which aids in diagnosis and monitoring. It does not directly treat or prevent a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device's measurements "are used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders," indicating its role in diagnosis. Furthermore, the "Device Description" clearly labels the i-STAT 1 Analyzer as an "in vitro diagnostic analytical device."
No
The device description clearly states that the system is comprised of hardware components (i-STAT 1 analyzer, test cartridges, accessories) in addition to any potential software within the analyzer. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is for the "in vitro quantification of total carbon dioxide in arterial or venous whole blood in point of care or clinical laboratory settings." The term "in vitro" is a key indicator of an IVD.
- Device Description: The description mentions analyzing "whole blood" and that the device is an "in vitro diagnostic analytical device."
- Regulatory Context: The document describes performance studies, including a comparison study with a predicate device (K042291), which is a standard requirement for regulatory submission of IVDs.
Therefore, based on the provided information, the i-STAT CHEM8+ cartridge with the i-STAT 1 System is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The i-STAT CHEM8+ cartridge with the i-STAT 1 System is in the in vitro quantification of total carbon dioxide in arterial or venous whole blood in point of care or clinical laboratory settings.
Carbon dioxide measurements are used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
Product codes
JFL
Device Description
The i-STAT CHEM8+ test cartridge contains test reagents to analyze whole blood at the point of care or in the clinical laboratory for total carbon dioxide (TCO2). The test is contained in a single-use, disposable cartridge. Cartridges require two to three drops of whole blood which are typically applied to the cartridge using a transfer device.
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 cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes).
The i-STAT 1 System is comprised of the i-STAT 1 analyzer, the i-STAT test cartridges and accessories (i-STAT 1 Downloader/Recharger, electronic simulator and portable printer). The system is designed for use by trained medical professionals at the patient point of care or in the clinical laboratory and is for prescription use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
trained medical professionals at the patient point of care or in the clinical laboratory
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision (Aqueous Materials):
- Study Type: 20-day multi-day precision testing based on CLSI document EP05-A3.
- Sample Size: For TCO2 CV L1: 81; For TCO2 CV L2 / Control L1*: 80; For TCO2 CV L3 / Control L2*: 80; For TCO2 CV L4 / Control L3*: 80; For TCO2 CV L4B: 81.
- Key Results:
- TCO2 CV L1: Mean 12.2 mmol/L, Total ST 0.29, %CVT 2.4
- TCO2 CV L2 / Control L1*: Mean 18.2 mmol/L, Total ST 0.31, %CVT 1.7
- TCO2 CV L3 / Control L2*: Mean 23.6 mmol/L, Total ST 0.64, %CVT 2.7
- TCO2 CV L4 / Control L3*: Mean 31.8 mmol/L, Total ST 1.36, %CVT 4.3
- TCO2 CV L4B: Mean 44.3 mmol/L, Total ST 0.93, %CVT 2.1
Precision (Whole Blood):
- Study Type: Whole blood repeatability analysis.
- Sample Size: 279 samples (178 venous and 101 arterial), measured in duplicate.
- Data Source: Data collected across three point of care sites.
- Key Results:
- Venous whole blood:
- Sample Range 7 - 15 mmol/L: N=15, Mean=9.43, SD=0.483, CV=5.1%
- Sample Range 15 - 25 mmol/L: N=61, Mean=21.25, SD=0.665, CV=3.1%
- Sample Range 25 - 35 mmol/L: N=82, Mean=27.72, SD=0.625, CV=2.3%
- Sample Range 35 - 47 mmol/L: N=20, Mean=39.33, SD=1.037, CV=2.6%
- Arterial whole blood:
- Sample Range 14 - 15 mmol/L: N=3, Mean=14.33, SD=0.577, CV=4.0%
- Sample Range 15 - 25 mmol/L: N=46, Mean=22.29, SD=0.521, CV=2.3%
- Sample Range 25 - 35 mmol/L: N=48, Mean=28.10, SD=0.520, CV=1.9%
- Sample Range 35 - 50 mmol/L: N=4, Mean=39.50, SD=0.866, CV=2.2%
- Venous whole blood:
Linearity:
- Study Type: Evaluation of Linearity based on CLSI EP06-A.
- Key Results: The i-STAT TCO2 test demonstrated linearity over the reportable range 5 - 50 mmol/L.
- Regression Summary: Slope = 1.0281, Intercept = -0.1259, R2 = 0.99379 (for TCO2 with a range tested of 4 - 52 mmol/L).
Limit of Quantitation (LoQ):
- Study Type: Evaluation of Detection Capability based on CLSI EP17-A2.
- Data Source: Whole blood altered to low TCO2 (≤ 5.0 mmol/L).
- Key Results: The LoQ for the i-STAT TCO2 test was determined to be 4 mmol/L.
Interference:
- Study Type: Interference Testing in Clinical Chemistry based on CLSI EP07-A2.
- Data Source: Whole blood test samples.
- Key Results: None of the substances evaluated (Bilirubin, Hemoglobin, Thiopental, Triglyceride, Intralipid) were found to interfere with the i-STAT TCO2 test.
Method Comparison with Predicate Device:
- Study Type: Method comparison study for agreement with the predicate device.
- Data Source: Conducted across three point of care sites.
- Sample Size: 294 specimens (183 lithium heparin venous whole blood, 111 lithium heparin arterial whole blood). 21 of 294 samples (7.14%) were contrived.
- Key Results:
- Combined Venous and Arterial Data: N=294, Slope=1.04, Intercept=0.17, r=0.97.
- Separate Venous whole blood: N=183*, y = -0.01 + 1.05x, r=0.98.
- Separate Arterial whole blood: N=111*, y = 1.07 + 1.03x, r=0.94.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics reported are:
- Precision: Total (%)CV, Repeatability (%)CVr, Between-Run (%)CVrr, Between-Day (%)CVdd, SD, CV (%)
- Linearity: Slope, Intercept, R2
- Accuracy/Method Comparison: Slope, Intercept, r (correlation coefficient)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1160 Bicarbonate/carbon dioxide test system.
(a)
Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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.
February 7, 2020
Abbott Point of Care Inc. Susan Tibedo Director, Regulatory Affairs 400 College Road East Princeton, NJ 08540
Re: K191298
Trade/Device Name: i-STAT CHEM8+ cartridge with the i-STAT 1 System Regulation Number: 21 CFR 862.1160 Regulation Name: Bicarbonate/carbon dioxide test system Regulatory Class: Class II Product Code: JFL Dated: January 6, 2020 Received: January 7, 2020
Dear Susan Tibedo:
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191298
Device Name
i-STAT CHEM8+ cartridge with the i-STAT 1 System
Indications for Use (Describe)
The i-STAT CHEM8+ cartridge with the i-STAT 1 System is in the in vitro quantification of total carbon dioxide in arterial or venous whole blood in point of care or clinical laboratory settings.
Carbon dioxide measurements are used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
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)
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3
510(k) Summary
The information in this 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
| 1. | Submitter Information | |
|---|---|---|
| Owner | Abbott Point of Care Inc. | |
| 400 College Road East | ||
| Princeton, NJ 08540 | ||
| Contact | Primary: Susan Tibedo | |
| Director Regulatory Affairs | ||
| susan.tibedo@abbott.com | ||
| Phone: 609-454-9360 |
Secondary: Maria Figueroa
Manager Regulatory Affairs
maria.l.figueroa@abbott.com
Phone: 609-454-9271 |
| | Date Prepared | February 5, 2020 |
| | 510k Number | K191298 |
2. Device Information
Proprietary Name i-STAT CHEM8+ Cartridge with i-STAT 1 Analyzer
Common Name Chemistry test, analyzer, handheld
| Product
code | Device Classification
name | Regulation
Number | Class | Panel |
|-----------------|--------------------------------------------|----------------------|-------|--------------------|
| JFL | Bicarbonate, Carbon
Dioxide Test System | 862.1160 | II | Clinical Chemistry |
3. Predicate Device
Proprietary Name SYNCHRON Systems TCO2 Reagent on UniCel DxC 600/800 SYNCHRON Clinical System
510(k) Number K042291
4
| Product
code | Device Classification
name | Regulation
Number | Class | Panel |
|-----------------|--------------------------------------------|----------------------|-------|--------------------|
| JFL | Bicarbonate, Carbon
Dioxide Test System | 862.1160 | II | Clinical Chemistry |
4. Device Description
The i-STAT CHEM8+ test cartridge contains test reagents to analyze whole blood at the point of care or in the clinical laboratory for total carbon dioxide (TCO2). The test is contained in a single-use, disposable cartridge. Cartridges require two to three drops of whole blood which are typically applied to the cartridge using a transfer device.
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 cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes).
The i-STAT 1 System is comprised of the i-STAT 1 analyzer, the i-STAT test cartridges and accessories (i-STAT 1 Downloader/Recharger, electronic simulator and portable printer). The system is designed for use by trained medical professionals at the patient point of care or in the clinical laboratory and is for prescription use only.
5. Intended Use Statement
The i-STAT CHEM8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of total carbon dioxide in arterial or venous whole blood in point of care or clinical laboratory settings.
Carbon dioxide measurements are used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
5
| Feature or
Characteristic | Predicate
SYNCHRON Systems TCO2
Reagent on UniCel DxC
600/800 SYNCHRON Clinical
System (K042291) | Candidate
i-STAT TCO2 Test with i-STAT 1
System |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The CO2 test is intended for the
quantitative determination of
carbon dioxide in human serum
or plasma.
Carbon dioxide measurements
are used in the diagnosis and
treatment of numerous
potentially serious disorders
associated with changes in body
acid-base balance. | The i-STAT CHEM8+ cartridge with
the i-STAT 1 System is intended for
use in the in vitro quantification of
total carbon dioxide in arterial or
venous whole blood in point of care
or clinical laboratory settings.
Carbon dioxide measurements are
used in the diagnosis, monitoring,
and treatment of numerous
potentially serious disorders
associated with changes in body
acid-base balance. |
| Reportable
Range | 5-50 mmol/L (Serum or Plasma) | 5-50 mmol/L (mEq/L) |
| Sample Type | Serum or plasma | Arterial or venous whole blood |
| Sample Volume | 0.5 mL (500 μL) | 95 μL |
| Preparation | Sample tubes prepared and then
processed within analyzer | Ready to Use |
| Traceability | Unknown traceability reference | IFCC Reference Measurement
Procedure |
| Calibration | Must be conducted every 24
hours and with each new
reagent | 1-point on-board contained within the
cartridge |
| Time to Test
(Sample
Stability) | Serum or plasma: Within 8 hours
at room temperature, or up to 48
hours if stored at +2°C to +8°C | Heparinized samples: within 10
minutes of collection |
| Principle of
Measurement | Ion selective electrode | Ion selective electrode |
| Reagent Format | Reagent handling system, stored
within analyzer | Cartridge |
| Reagent Storage
and Stability | Room temperature | 2°C to 8°C (35-46°F) |
| Analyzer Type | Floor Model | Handheld |
-
- Summary Comparison of Technological Characteristics
6
7. Performance Characteristics
Analytical Performance
a. Precision
Precision 20 days (Aqueous Materials)
The precision of the i-STAT TCO2 test on the i-STAT 1 Wireless Analyzer was evaluated using 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 instruments and one test cartridge lot over 20 days at one site. Total precision ( 'within-laboratory', Sr), within-run, (Sr), between-run, (Sr) and between-day, (Saa) were estimated for each level. The results of the 20-day precision study are shown in Table 1.
| Table 1: 20-Day Precision of i-STAT TCO2 test on the i-STAT 1 Analyzer | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Analyte | Fluid Level | N | Mean/ | ||||||||
| Median | Total | Repeatability | Between-Run | Between-Day | |||||||
| ST | %CVT | Sr | %CVr | Srr | %CVrr | Sdd | %CVdd | ||||
| TCO2 | |||||||||||
| mmol/L | CV L1 | 81 | 12.2 | 0.29 | 2.4 | 0.26 | 2.1 | 0.08 | 0.7 | 0.08 | 0.7 |
| CV L2 / | |||||||||||
| Control L1* | 80 | 18.2 | 0.31 | 1.7 | 0.30 | 1.6 | 0.07 | 0.4 | 0.07 | 0.4 | |
| CV L3 / | |||||||||||
| Control L2* | 80 | 23.6 | 0.64 | 2.7 | 0.58 | 2.5 | 0.21 | 0.9 | 0.15 | 0.6 | |
| CV L4 / | |||||||||||
| Control L3*, | 80 | 31.8 | 1.36 | 4.3 | 1.26 | 4.0 | 0.20 | 0.6 | 0.49 | 1.5 | |
| CV L4B | 81 | 44.3 | 0.93 | 2.1 | 0.69 | 1.6 | 0.32 | 0.7 | 0.53 | 1.2 |
- The aqueous control materials (Control L1, L2, L3) are also used as the middle levels of the calibration verification set (CV L2, CV L3, CV L4). The aqueous fluids are the same.
Precision (Whole Blood)
A whole blood repeatability analysis was conducted using the data collected across three point of care sites. Two hundred and seventy-nine samples (178 venous and 101 arterial) were measured in duplicate. The mean values for each sample were divided into four subintervals for each sample type taking into consideration the medical decision levels of 6, 20, and 33 mmol/L.
The results are provided in Table 2 and Table 3 below:
7
| Table 2: Venous whole blood | ||||||||
|---|---|---|---|---|---|---|---|---|
| Sample Range | ||||||||
| (mmol/L) | N | Mean | ||||||
| (mmol/L) | SD | CV (%) | ||||||
| 7 - 15 | 15 | 9.43 | 0.483 | 5.1 | ||||
| 15 - 25 | 61 | 21.25 | 0.665 | 3.1 | ||||
| 25 - 35 | 82 | 27.72 | 0.625 | 2.3 | ||||
| 35 - 47 | 20 | 39.33 | 1.037 | 2.6 |
| Table 3: Arterial whole blood | ||||
|---|---|---|---|---|
| Sample Range | ||||
| (mmol/L) | N | Mean | ||
| (mmol/L) | SD | CV (%) | ||
| 14 - 15 | 3 | 14.33 | 0.577 | 4.0 |
| 15 - 25 | 46 | 22.29 | 0.521 | 2.3 |
| 25 - 35 | 48 | 28.10 | 0.520 | 1.9 |
| 35 - 50 | 4 | 39.50 | 0.866 | 2.2 |
b. Linearity
The study was designed based on CLSI EP06-A: Evaluation of the Linearity of Quantitative Measurement Procedures.
The linearity of the i-STAT TCO2 test on the i-STAT 1 Analyzer was evaluated by preparing whole blood samples of varying analyte levels that spanned the reportable range of the test. The i-STAT TCO2 test demonstrated linearity over the reportable range 5 - 50 mmol/L. Regression summary of the TCO2 response (in mmol/L) versus the concentration of the whole blood samples of varying analyte levels is provided in Table 4.
| Table 4: Regression Summary for the i-STAT TCO2 test on the i-STAT 1 Analyzer | |||||
|---|---|---|---|---|---|
| i-STAT Test | |||||
| (mmol/L) | Reportable | ||||
| Range (mmol/L) | Range Tested | ||||
| (mmol/L) | Slope | Intercept | R2 | ||
| TCO2 | 5 - 50 | 4 - 52 | 1.0281 | -0.1259 | 0.99379 |
c. 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 TCO2 test was evaluated on the i-STAT 1 Analyzer using whole blood that was altered to low TCO2 (≤ 5.0 mmol/L). The study was conducted over four (4) days using two (2) cartridge lots. The LoQ for the i-STAT TCO2 test was determined to be 4 mmol/L, which is below the lower limit of the i-STAT TCO2 test reportable range (5 - 50 mmol/L).
d. Interference
The interference performance of the i-STAT TCO2 test on the i-STAT 1 Analyzer was evaluated using whole blood test samples based on CLSI EP07-A2: Interference
8
Testing in Clinical Chemistry; Approved Guideline - Second Edition. The effect of each substance at each TCO2 level was evaluated by comparing the performance of a test sample spiked to a high concentration of the substance and a control sample spiked with an equal volume of solvent. A substance was identified as an interferent if the difference between the spiked test sample and the control was greater than the allowable error defined as the greater of 4 mmol/L or 10% of the mean TCO2 result for the control sample. None of the substances evaluated (See Table 5) were found to interfere with the i-STAT TCO2 test.
| Table 5: List of Substances and Test Concentrations | ||
|---|---|---|
| Substance | Test Concentration* | |
| as specified | mg/dL | |
| Bilirubin | 342 $\mu$ mol/L | 20 |
| Hemoglobin | 2 g/L | 200 |
| Thiopental | 248 $\mu$ mol/L | 6.01 |
| Triglyceride | 37 mmol/L | 3233.8 |
| Intralipid | N/A | 7092 |
*The molecular weight of the substance tested was used to convert the test concentration from mmol/L to mg/dL. The molecular weight of each substance could vary depending on the form chosen.
Comparison Study
e. Method Comparison with Predicate Device
The accuracy of the TCO2 assay on the i-STAT CHEM8+ (blue) cartridge on the i-STAT 1 Analyzer was evaluated by a method comparison study for agreement with the predicate device. The study was conducted across three point of care sites. A total of 294 specimens, 183 lithium heparin venous whole blood specimens and 111 lithium heparin arterial whole blood specimens were tested. Twenty-one of 294 samples (7.14%) were contrived.
| Table 6: Passing-Bablok Regression Summary of Venous and Arterial Data
| Combined | ||||
|---|---|---|---|---|
| i-STAT Test | N | Slope | Intercept | r |
| TCO2 | 294 | 1.04 | 0.17 | 0.97 |
The data was analyzed separately for venous whole blood and arterial whole blood samples by Passing-Bablok regression analysis comparing the first replicate of the candidate device results to the singlicate result of lithium heparin plasma samples on the predicate device. Results are presented in Table 7 and Table 8 below.
9
| Site | N | Sample Range Tested
(mmol/L) | Regression
Equation | r |
|----------|------|---------------------------------|------------------------|------|
| 1 | 23 | 19 – 33 | y = 1.83 + 0.98x | 0.87 |
| 2 | 50 | 9 – 41 | y = 0.00 + 1.00x | 0.98 |
| 3 | 93 | 15 – 46 | y = 0.00 + 1.08x | 0.98 |
| combined | 183* | 6 – 46 | y = -0.01 + 1.05x | 0.98 |
- Includes 17 contrived specimens.
| Site | N | Sample Range Tested (mmol/L) | Regression Equation | r |
|---|---|---|---|---|
| 1 | 53 | 14 – 39 | y = 3.58 + 0.97x | 0.96 |
| 2 | 48 | 15 – 50 | y = 1.00 + 1.00x | 0.96 |
| 3 | 6 | 23 – 29 | N/A | |
| combined | 111* | 7 – 50 | y = 1.07 + 1.03x | 0.94 |
- Includes 4 contrived specimens.
8. Conclusion
The results of these studies demonstrate that performance of the i-STAT CHEM8+ TCO2 test with the i-STAT 1 System are substantially equivalent to the comparative method.