(427 days)
Not Found
No
The summary describes a standard in vitro diagnostic device that uses electrochemical sensors to measure hematocrit. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on analytical metrics, not AI/ML model performance.
No.
The device is an in vitro diagnostic device used to quantify hematocrit levels, which aids in the determination and monitoring of conditions, not in their direct treatment or therapy.
Yes
The device aids in the determination and monitoring of normal total red cell volume status, which can be associated with conditions like anemia and erythrocytosis, thereby providing information for diagnosis.
No
The device description explicitly states that the system is comprised of hardware components (i-STAT 1 analyzer, cartridges, accessories) in addition to any potential software. 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 it is for "in vitro quantification of hematocrit in arterial or venous whole blood". "In vitro" means outside of the living organism, and "quantification" refers to measuring a specific substance.
- Device Description: The "Device Description" further clarifies that the system analyzes "whole blood at the point of care or in the clinical laboratory". This confirms it's used to test biological samples.
- System Components: The description of the "i-STAT 1 System" includes the "i-STAT 1 analyzer" and "i-STAT test cartridges", which are designed to work together for in vitro diagnostic testing.
- Regulatory Language: The description mentions it is a "handheld, in vitro diagnostic analytical device".
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes.
N/A
Intended Use / Indications for Use
The i-STAT CHEM8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of hematocrit in arterial or venous whole blood in point of care or clinical laboratory settings.
Hematocrit measurements can aid in the determination and monitoring of normal total red cell volume status that can be associated with conditions including anemia and erythrocytosis.
The i-STAT Hematocrit test has not been evaluated in neonates.
Product codes (comma separated list FDA assigned to the subject device)
JPI
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 hematocrit (HCT). 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
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The i-STAT Hematocrit test has not been evaluated in neonates.
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
Not Found
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)
Analytical Performance
a. Precision
- Precision 20 days (Aqueous Materials)
- Study type: 20-day precision study based on CLSI document EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline-Third Edition.
- Sample size: 4 levels of aqueous materials, conducted over 20 days at one site. N=80 or 81 for each level.
- Key results: Total precision ('within-laboratory', ST), within-run, (Sr), between-run, (Sm) and between-day, (Saa) were estimated for each level. CV L2 / Control L1: Mean 20.5 %PCV, ST 0.22 %PCV (CV 1.1%). CV L3 / Control L2: Mean 32.4 %PCV, ST 0.31 %PCV (CV 1.0%). CV L4 / Control L3: Mean 53.2 %PCV, ST 1.02 %PCV (CV 1.9%). CV L5: Mean 63.9 %PCV, ST 0.87 %PCV (CV 1.4%).
- Precision (Whole Blood)
- Study type: Whole blood repeatability analysis.
- Sample size: 190 samples (123 venous and 67 arterial), measured in duplicate.
- Key results:
- Venous whole blood: Sample Range ≤ 35 %PCV (N=48, Mean 28.6 %PCV, CV 1.6%). Sample Range 36 - 50 %PCV (N=66, Mean 42.5 %PCV, CV 1.4%). Sample Range > 50 %PCV (N=9, Mean 60.0 %PCV, CV 0.8%).
- Arterial whole blood: Sample Range ≤ 35 %PCV (N=40*, Mean 27.2 %PCV, CV 7.1%). Sample Range 36 - 50 %PCV (N=21, Mean 39.9 %PCV, CV 2.0%). Sample Range > 50 %PCV (N=6, Mean 62.9 %PCV, CV 1.0%).
b. Linearity
- Study type: Linearity evaluation based on CLSI EP06-A: Evaluation of the linearity of quantitative measurement procedures.
- Sample size: Whole blood samples of varying analyte levels.
- Key results: The best fitting regression model was a third order model. The absolute degree of nonlinearity results met the acceptance criteria. The i-STAT Hematocrit test demonstrated linearity over the reportable range 15 - 75 %PCV. Regression summary: Slope 1.0482, Intercept -2.0584, R2 0.9973.
c. Limit of Quantitation (LoQ)
- Study type: Evaluation based on CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline-Second Edition.
- Sample size: Four whole blood samples altered to low hematocrit levels (8.0 g/dL showed interference at 10.2 g/dL for Hct (50000 WBC/uL showed increased results).
f. Method Comparison with Predicate Device
- Study type: Method comparison study based on CLSI guideline EP09c-ED3.
- Sample size: N=194 (total venous and arterial blood specimens).
- Key results: A Passing-Bablok linear regression analysis was performed. Slope 1.030, Intercept -0.530, r 1.00. The results demonstrate that performance of the i-STAT CHEM8+ Hematocrit test with the i-STAT 1 System are substantially equivalent to the comparative method.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (Accuracy is discussed in terms of linearity, precision, and method comparison - no sensitivity/specificity/PPV/NPV given)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 864.6400 Hematocrit measuring device.
(a)
Identification. A hematocrit measuring device is a system consisting of instruments, tubes, racks, and a sealer and a holder. The device is used to measure the packed red cell volume in blood to determine whether the patient's total red cell volume is normal or abnormal. Abnormal states include anemia (an abnormally low total red cell volume) and erythrocytosis (an abnormally high total red cell mass). The packed red cell volume is produced by centrifuging a given volume of blood.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
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Image /page/0/Picture/0 description: The image contains 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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 28, 2020
Abbott Point of Care Inc. Susan Tibedo Director Regulatory Affairs Abbott Laboratories 400 College Road East Princeton, New Jersey 08540
Re: K183680
Trade/Device Name: i-STAT CHEM8+ cartridge with the i-STAT 1 System Regulation Number: 21 CFR 864.6400 Regulation Name: Hematocrit measuring device Regulatory Class: Class II Product Code: JPI Dated: January 23, 2020 Received: January 24, 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.
1
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
- 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.
Takeesha Taylor-Bell Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183680
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 intended for use in the in vitro quantification of hematocrit in arterial or venous whole blood in point of care or clinical laboratory settings.
Hematocrit measurements can aid in the determination and monitoring of normal total red cell volume status that can be associated with conditions including anemia and erythrocytosis.
The i-STAT Hematocrit test has not been evaluated in neonates.
| 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 19, 2020 |
| | 510(k) Number | K183680 |
2. Device Information
Proprietary Name i-STAT CHEM8+ cartridge with i-STAT 1 System
Common Name Chemistry test, analyzer, handheld
| Product
code | Device Classification
name | Regulation
Number | Class | Panel |
|-----------------|---------------------------------|----------------------|-------|------------|
| JPI | Device, Hematocrit
Measuring | 862.6400 | II | Hematology |
3. Predicate Device
Proprietary Name i-STAT Hematocrit test on the i-STAT EC4+ cartridge with the i-STAT Alinity System
510(k) Number K163342
| Product
code | Device Classification
name | Regulation
Number | Class | Panel |
|-----------------|---------------------------------|----------------------|-------|------------|
| JPI | Device, Hematocrit
Measuring | 862.6400 | II | Hematology |
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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 hematocrit (HCT). 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 hematocrit in arterial or venous whole blood in point of care or clinical laboratory settings. Hematocrit measurements can aid in the determination and monitoring of normal or abnormal total red cell volume status that can be associated with conditions including anemia and erythrocytosis. The i-STAT Hematocrit test has not been evaluated in neonates.
| Similarities and Differences | ||
|---|---|---|
| Feature or | ||
| Characteristic | Predicate Device (K163342): | |
| i-STAT Hematocrit test on the i-STAT | ||
| EC4+ cartridge with the | ||
| i-STAT Alinity System | Candidate Device: | |
| i-STAT Hematocrit test with the i-STAT | ||
| 1 System | ||
| Intended Use | The i-STAT Hematocrit test is intended | |
| for use in the in vitro quantification of | ||
| packed red blood cell volume fraction in | ||
| arterial or venous heparinized whole | ||
| blood, or in arterial or venous non- | ||
| anticoagulated whole blood. | ||
| Hematocrit measurements can aid in the | ||
| determination and monitoring of normal or | ||
| abnormal total red cell volume status that | ||
| can be associated with conditions | ||
| including anemia and erythrocytosis. | ||
| The i-STAT Hematocrit test with the | ||
| i-STAT Alinity System has not been | ||
| evaluated in neonates. | The i-STAT CHEM8+ cartridge with | |
| the i-STAT 1 System is intended for | ||
| use in the in vitro quantification of | ||
| hematocrit in arterial or venous whole | ||
| blood in point of care or clinical | ||
| laboratory settings. | ||
| Hematocrit measurements can aid in | ||
| the determination and monitoring of | ||
| normal or abnormal total red cell | ||
| volume status that can be associated | ||
| with conditions including anemia and | ||
| erythrocytosis. | ||
| The i-STAT Hematocrit test has not | ||
| Similarities and Differences | ||
| Feature or | ||
| Characteristic | Predicate Device (K163342): | |
| i-STAT Hematocrit test on the i-STAT | ||
| EC4+ cartridge with the | ||
| i-STAT Alinity System | Candidate Device: | |
| i-STAT Hematocrit test with the i-STAT | ||
| 1 System | ||
| The i-STAT Hematocrit test with the | ||
| i-STAT Alinity System is not for use with | ||
| capillary samples. | been evaluated in neonates. | |
| Reportable | ||
| Range | 15 - 75 %PCV | Same |
| Sample Type | Arterial or venous whole blood | Arterial or venous whole blood |
| Sample | ||
| Volume | 65 μL | 95 μL |
| Sample | ||
| preparation | Ready to use | Same |
| Test | ||
| Traceability | Microhematocrit Method | Same |
| Calibration | 1-point on-board (contained within the | |
| cartridge) | Same | |
| Analysis Time | ~2 minutes | Same |
| Principle of | ||
| Measurement | Hematocrit is measured using the | |
| conductivity method. | Same | |
| Reagent | ||
| Format | Cartridge | Same |
| Storage and | ||
| Stability | Storage: 2°C to 8°C | |
| (35-46°F) | Same | |
| Cartridge | ||
| Case | White | Blue |
| Case thumb | ||
| well | Small | Large, extends below the cartridge latch |
| Sample well | Visibly low contrast | Visibly high contrast |
6. Summary Comparison of Technological Characteristics
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7. Performance Characteristics
Analytical Performance
a. Precision
Precision 20 days (Aqueous Materials)
The precision of the i-STAT Hematocrit test on the i-STAT 1 Analyzer was evaluated using 4 levels of aqueous materials. This 20-day precision study 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 ('withinlaboratory', ST), within-run, (Sr), between-run, (Sm) 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 Study Results HCT Test on the i-STAT 1 Wireless Analyzer | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Fluid Level | N | Mean | ||||||||
| % PCV | Total | Within-run | Between-run | Between-day | ||||||
| ST | ||||||||||
| %PCV | CVT | |||||||||
| (%) | Sr | |||||||||
| %PCV | CVr | |||||||||
| (%) | Srr | |||||||||
| %PCV | CVrr | |||||||||
| (%) | Sdd | |||||||||
| %PCV | CV dd | |||||||||
| (%) | ||||||||||
| CV L2 / | ||||||||||
| Control L1 | 80 | 20.5 | 0.22 | 1.1 | 0.20 | 1.0 | 0.08 | 0.4 | 0.06 | 0.3 |
| CV L3 / | ||||||||||
| Control L2 | 80 | 32.4 | 0.31 | 1.0 | 0.29 | 0.9 | 0.08 | 0.2 | 0.07 | 0.2 |
| CV L4 / | ||||||||||
| Control L3 | 81 | 53.2 | 1.02 | 1.9 | 0.94 | 1.8 | 0.26 | 0.5 | 0.30 | 0.6 |
| CV L5 | 80 | 63.9 | 0.87 | 1.4 | 0.79 | 1.2 | 0.31 | 0.5 | 0.18 | 0.3 |
Precision (Whole Blood)
A whole blood repeatability analysis was conducted using the data collected across three point of care sites. One hundred and ninety samples (123 venous and 67 arterial) were measured in duplicate. The mean values for each sample were divided into three subintervals for each sample type.
The results are provided in Table 2 and Table 3 below:
| Table 2: Venous whole blood | ||||
|---|---|---|---|---|
| Sample Range | ||||
| (%PCV) | N | Mean (%PCV) | SD | CV (%) |
| ≤ 35 | 48 | 28.6 | 0.44 | 1.6 |
| 36 - 50 | 66 | 42.5 | 0.60 | 1.4 |
| > 50 | 9 | 60.0 | 0.47 | 0.8 |
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| Table 3: Arterial whole blood | ||||
|---|---|---|---|---|
| Sample Range | ||||
| (%PCV) | N | Mean (%PCV) | SD | CV (%) |
| ≤ 35 | 40* | 27.2 | 1.93 | 7.1 |
| 36 - 50 | 21 | 39.9 | 0.82 | 2.0 |
| > 50 | 6 | 62.9 | 0.65 | 1.0 |
*outliers included
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 Hematocrit 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 best fitting regression model was a third order model. The absolute degree of nonlinearity results met the acceptance criteria for each of the levels tested. Therefore, the i-STAT Hematocrit test demonstrated linearity over the reportable range 15 - 75 %PCV. Regression summary of the Hematocrit response versus the concentration of the whole blood samples of varying analyte levels is also provided in Table 4.
| Table 4: Regression Summary for the i-STAT Hematocrit test on the i-STAT 1 Analyzer | |||||
|---|---|---|---|---|---|
| i-STAT Test | Reportable | ||||
| Range (%PCV) | Range Tested | ||||
| (%PCV) | Slope | Intercept | R2 | ||
| Hematocrit | 15 – 75 %PCV | 14 - 79 | 1.0482 | -2.0584 | 0.9973 |
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 LoO of the i-STAT Hematocrit test was evaluated on the i-STAT 1 Analyzer using four whole blood samples altered to low hematocrit levels (8.0 g/dL) showed interference at 10.2 g/dL for Hct (50000
WBC/uL* | >50000
WBC/uL | Yes | WBC at >50000 WBC/uL showed increased results |
*No CLSI EP37 1st edition test concentration available. Concentration from recently cleared device.
Comparison Study
f. Method Comparison with Predicate Device
Method comparison was demonstrated in a study comparing the performance of the i-STAT Hematocrit test with the i-STAT 1 System to the performance of the i-STAT
1 The molecular weight of the compound tested was used to concentration from mmol/L to mg/dL. The molecular weight of each compound could vary depending on the form chosen.
9
Hematocrit test with the i-STAT Alinity Instrument. The study was based on CLSI guideline EP09c-ED3. Venous and arterial blood specimens were evaluated and analyzed on the i-STAT 1 analyzer against venous and arterial blood specimens on the i-STAT Alinity instrument. A Passing-Bablok linear regression analysis was performed using the first replicate result from the i-STAT 1 versus the mean result of the comparative method.
The i-STAT System automatically runs a comprehensive set of quality checks of both the analyzer and cartridge performance each time a sample is tested. This internal quality system will suppress results by generating a Quality Check Code (QCC) if the analyzer, cartridge or sample does not meet certain internal specifications. When a QCC occurs, a single code number, the type of problem and the next step to be taken will be displayed on the i-STAT Analyzer. The failure rate for a single cartridge due to QCCs may be as high as 4%. The rate of failure for two consecutive cartridges due to QCCs may be as high as 1.7%.
| Table 6: Method Comparison Results | ||||
|---|---|---|---|---|
| i-STAT Test | N | Slope | Intercept | r |
| Hematocrit | 194 | 1.030 | -0.530 | 1.00 |
8. Conclusion
The results of these studies demonstrate that performance of the i-STAT CHEM8+ Hematocrit test with the i-STAT 1 System are substantially equivalent to the comparative method.