(406 days)
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No
The description focuses on standard electrochemical and analytical methods for quantifying glucose and creatinine, with no mention of AI or ML algorithms for data processing or interpretation.
No
The device is an in vitro diagnostic (IVD) analytical device used for the quantification of glucose and creatinine in blood, which aids in diagnosis and monitoring, but it does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "detection and quantification of… biomarkers to aid in diagnosis of a disease or condition."
No
The device description explicitly states that the system is comprised of both hardware (i-STAT 1 analyzer, accessories) and disposable cartridges containing reagents, in addition to any software that runs on 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 the device is for "in vitro quantification of glucose, and creatinine in arterial or venous whole blood". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Device Description: The description mentions analyzing "whole blood" and using "test reagents," which are components typically used in in vitro diagnostic tests. It also describes the i-STAT 1 Analyzer as a "handheld, in vitro diagnostic analytical device."
- Regulatory Context: The presence of a "Predicate Device(s)" section with K numbers (K042291) indicates that this device is being compared to previously cleared IVD devices, which is a standard part of the regulatory process for new IVDs.
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 glucose, and creatinine in arterial or venous whole blood in point of care or clinical laboratory settings.
Glucose measurements are used in the diagnosis, monitoring, and treatment of carbohydrate metabolism disorders including, but not limited to, diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma.
Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Product codes (comma separated list FDA assigned to the subject device)
CGA, CGL
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 glucose and creatinine. 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
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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
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 (aqueous materials)
Study Type: 20-day multi-day precision testing based on CLSI document EP05-A3.
Sample Size: 80-81 measurements per fluid level for both Creatinine and Glucose assays.
Key Results: The study demonstrated good precision for both Creatinine and Glucose tests. For Creatinine, total CV ranged from 2.1% to 15.6% across 5 levels. For Glucose, total CV ranged from 0.4% to 1.8% across 5 levels.
Precision (Whole Blood)
Study Type: Whole blood precision evaluation across three point-of-care sites.
Sample Size: 20-21 test results per sample per instrument at each site, with 7 i-STAT 1 Wireless Analyzers per site.
Key Results: Whole blood precision was evaluated for both Glucose and Creatinine. For Glucose, total %CV ranged from 0.4% to 1.3%. For Creatinine, total %CV ranged from 1.4% to 10.4%.
b. Linearity
Study Type: Linearity study based on CLSI EP06-A.
Key Results: The i-STAT Glucose and Creatinine tests demonstrated linearity over their reportable ranges.
Glucose: Range Tested 17 - 620 mg/dL, Slope 0.9794, Intercept -1.603, R2 0.9991.
Creatinine: Range Tested 0.13 - 16.2 mg/dL, Slope 1.021, Intercept 0.0763, R2 0.9978.
c. Limit of Quantitation (LoQ)
Study Type: Evaluation based on CLSI EP17-A2.
Key Results: LoQ for i-STAT Glucose was 12 mg/dL. LoQ for i-STAT Creatinine was 0.10 mg/dL. Both are below the lower limit of their respective reportable ranges.
d. Limit of Blank and Detection (LoB/LoD)
Study Type: Evaluation based on CLSI EP17-A2.
Key Results:
Creatinine: LoB 0.05 mg/dL, LoD 0.10 mg/dL.
Glucose: LoB 1 mg/dL, LoD 2 mg/dL.
e. Hematocrit Sensitivity to the i-STAT Glucose Test
Key Results: The study demonstrated that the i-STAT Glucose test performs equivalently at different hematocrit levels.
f. Oxygen Sensitivity
Key Results: The i-STAT Creatinine and Glucose tests are insensitive to oxygen changes (20 to >500 mmHg for creatinine and 25 to >500 mmHg for glucose).
g. Altitude
Key Results: Equivalent creatinine results at elevations up to 6367 feet (r 1.00, Slope 1.13) and for glucose up to 9523 feet (r 1.00, Slope 1.00).
h. Interference
Study Type: Interference performance evaluated based on CLSI EP07 ED3 and EP37 ED1.
Key Results:
i-STAT Glucose Test: Lithium Bromide (≥ 11.8 mmol/L) caused decreased results. Hydroxyurea (≥ 0.08 mmol/L) caused increased results. All other tested substances did not show interference.
i-STAT Creatinine Test: Lithium Bromide (≥ 18.3 mmol/L) caused increased results. Hydroxyurea (≥ 0.03 mmol/L) caused increased results. All other tested substances did not show interference.
Comparison Study
i. Method Comparison with Predicate Device
Study Type: Method comparison study based on CLSI guideline EP09c-ED3, comparing i-STAT 1 to Beckman DxC.
Sample Size: N=185 for Glucose, N=180 for Creatinine.
Key Results: Passing-Bablok linear regression analysis showed strong correlation and acceptable agreement with the predicate device.
Glucose: Slope 0.98, Intercept 0.00, r 1.00.
Creatinine: Slope 1.043, Intercept -0.062, r 1.00.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 7, 2020
Abbott Point of Care Inc. Susan Tibedo Director, Regulatory Affairs 400 College Road East Princeton, NJ 08540
Re: K183678
Trade/Device Name: i-STAT CHEM8+ cartridge with the i-STAT 1 System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: CGA, CGL Dated: January 9, 2020 Received: January 10, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (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,
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) K183678
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 glucose, and creatinine in arterial or venous whole blood in point of care or clinical laboratory settings.
Glucose measurements are used in the diagnosis, monitoring, and treatment of carbohydrate metabolism disorders including, but not limited to, diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma.
Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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 |
| 510(k) Number | K183678 |
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 |
|-----------------|-----------------------------------------------|----------------------|-------|--------------------|
| CGA | Glucose Oxidase, Glucose | 862.1345 | II | Clinical Chemistry |
| CGL | Electrode, Ion Based
Enzymatic, Creatinine | 862.1225 | II | Clinical Chemistry |
4
3. Predicate Device
| Proprietary | SYNCHRON Systems Glucose Reagent on UniCel DxC |
|---|---|
| Name | 600/800 SYNCHRON Clinical System |
SYNCHRON Systems Creatinine Reagent on UniCel DxC 600/800 SYNCHRON Clinical System
510(k) Number K042291
| Product
code | Device Classification
name | Regulation
Number | Class | Panel |
|-----------------|----------------------------------------------|----------------------|-------|--------------------|
| CGA | Glucose Oxidase, Glucose | 862.1345 | II | Clinical Chemistry |
| CGX | Alkaline Picrate,
Colorimetry, Creatinine | 862.1225 | 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 glucose and creatinine. 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 glucose and creatinine in arterial or venous whole blood in point of care or clinical laboratory settings.
Glucose measurements are used in the diagnosis, monitoring, and treatment of carbohydrate metabolism disorders including, but not limited to, diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
5
| Feature or
| Characteristic | Predicate | Candidate |
|---|---|---|
| Intended Use | SYNCHRON Systems | |
| Glucose Reagent on UniCel | ||
| DxC 600/800 SYNCHRON | ||
| Clinical System (K042291) | ||
| The glucose test system is intended | ||
| for the quantitative determination of | ||
| glucose concentration in human | ||
| serum, plasma, urine or | ||
| cerebrospinal fluid (CSF). |
Glucose measurements are used in
the diagnosis and treatment of
carbohydrate metabolism disorders
including diabetes mellitus, neonatal
hypoglycemia, idiopathic
hypoglycemia, and pancreatic islet
cell carcinoma. | Glucose Test with i-STAT 1 System
The i-STAT CHEM8+ cartridge with the
i-STAT 1 System is intended for use in
the in vitro quantification of glucose and
creatinine in arterial or venous whole
blood in point of care or clinical
laboratory settings.
Glucose measurements are used in the
diagnosis, monitoring, and treatment of
carbohydrate metabolism disorders
including, but not limited to, diabetes
mellitus, neonatal hypoglycemia,
idiopathic hypoglycemia, and pancreatic
islet cell carcinoma. |
| Reportable Range | 0.2 – 33.3 mmol/L (Serum, Plasma)
0 – 600 mg/dL
up to 1200 mg/dL by sample
dilution | 1.1 – 38.9 mmol/L (mEq/L)
20 – 700 mg/dL
0.20 – 7.00 g/L |
| Sample Type | Serum, plasma, urine, CSF | Arterial or venous whole blood |
| Sample Volume | 0.5 mL (500 µL) | 95 µL |
| Sample
Preparation | Sample tubes prepared and then
processed within analyzer | Ready to Use |
| Traceability | NIST SRM 917 | NIST SRM 965 |
| 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
Urine: Within 2 hours of collection | Heparinized samples: within 30 minutes of
collection |
| Principle of
Measurement | O2 depletion by glucose oxidase
activity | Amperometric measurement of oxidized
hydrogen peroxide produced by glucose
oxidase activity |
| 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 |
6. Summary Comparison of Technological Characteristics
6
| Similarities and Differences: System (Test and Instrument): Creatinine (CREA) | ||
|---|---|---|
| Feature or | ||
| Characteristic | Predicate | |
| SYNCHRON Systems | ||
| Creatinine Reagent on UniCel | ||
| DxC 600/800 SYNCHRON | ||
| Clinical System (K042291) | Candidate | |
| CREA Test with i-STAT 1 System | ||
| Intended Use | The creatinine test system is intended | |
| for the quantitative determination of | ||
| creatinine in human serum and urine. | ||
| Measurements of creatinine are used | ||
| in the diagnosis and treatment of | ||
| renal disease. Serum creatinine | ||
| measurements prove useful in | ||
| evaluation of kidney glomerular | ||
| function and in monitoring renal | ||
| dialysis. | The i-STAT CHEM8+ cartridge with the | |
| in vitro quantification of glucose and | ||
| creatinine in arterial or venous whole | ||
| blood in point of care or clinical | ||
| laboratory settings. | ||
| Creatinine measurements are used in the | ||
| diagnosis and treatment of renal diseases, | ||
| in monitoring renal dialysis, and as a | ||
| calculation basis for measuring other | ||
| urine analytes. | ||
| Reportable Range | 0.1 – 25.0 mg/dL (Serum) | 0.2-20.0 mg/dL |
| Sample Type | Serum, urine | Arterial or venous whole blood |
| Sample Volume | 0.5 mL (500 $\mu$ L) | 95 $\mu$ L |
| Sample | ||
| Preparation | Sample tubes prepared and then | |
| processed within analyzer | Ready to Use | |
| Traceability | Isotope Dilution Mass Spectroscopy | NIST SRM 967 |
| 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 |
Urine: Within 2 hours of collection | Heparinized samples: within 30 minutes
of collection |
| Principle of
Measurement | Colorimetric (520 nm) measurement
of creatinine-alkaline picrate
complex formation | Amperometric measurement of oxidized
hydrogen peroxide produced by
creatinine amidinohydrolase activity |
| 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 |
7
7. Performance Characteristics
Analytical Performance
- a. Precision
Precision 20 days (aqueous materials)
The precision of the i-STAT Glucose and Creatinine tests 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 Glucose and Creatinine tests on the i-STAT 1
| Analyzer | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| i-STAT | |||||||||||
| Test | Fluid | ||||||||||
| Level | N | Mean | Total | Within-run | Between-run | Between-day | |||||
| ST | CVT | ||||||||||
| (%) | Sr | CVr | |||||||||
| (%) | Srr | CVrr | |||||||||
| (%) | Sdd | CVdd | |||||||||
| (%) | |||||||||||
| Creatinine | |||||||||||
| (mg/dL) | CV L1 | 81 | 15.90 | 0.337 | 2.1 | 0.321 | 2.0 | 0.096 | 0.6 | 0.030 | 0.2 |
| CV L2 | 81 | 4.23 | 0.101 | 2.4 | 0.093 | 2.2 | 0.029 | 0.7 | 0.027 | 0.6 | |
| CV L3 | 81 | 1.69 | 0.035 | 2.1 | 0.033 | 2.0 | 0.008 | 0.5 | 0.007 | 0.4 | |
| CV L4 | 80 | 0.51 | 0.029 | 5.7 | 0.027 | 5.3 | 0.008 | 1.6 | 0.006 | 1.2 | |
| CV L5 | 80 | 0.18 | 0.028 | 15.6 | 0.026 | 14.4 | 0.007 | 3.9 | 0.007 | 3.9 | |
| Glucose | |||||||||||
| (mg/dL) | CV L1 | 80 | 26.7 | 0.49 | 1.8 | 0.47 | 1.8 | 0.13 | 0.5 | 0.10 | 0.4 |
| CV L2 | 81 | 40.9 | 0.52 | 1.3 | 0.46 | 1.1 | 0.16 | 0.4 | 0.18 | 0.4 | |
| CV L3 | 81 | 123.0 | 0.47 | 0.4 | 0.43 | 0.3 | 0.13 | 0.1 | 0.12 | 0.1 | |
| CV L4 | 80 | 286.5 | 1.40 | 0.5 | 1.25 | 0.4 | 0.55 | 0.2 | 0.33 | 0.1 | |
| CV L5 | 80 | 608.1 | 5.56 | 0.9 | 5.21 | 0.9 | 1.46 | 0.2 | 1.31 | 0.2 |
Precision (Whole Blood)
The whole blood precision of the i-STAT Glucose and Creatinine Tests on the i-STAT 1 Analyzer were evaluated using venous whole blood (native or altered) samples targeted to four levels within the test reportable range.
One test cartridge lot was used across 3 point of care sites. At each site, each sample was tested 3 times on each of 7 i-STAT 1 Wireless Analyzers (total of 21 test results per sample per instrument). The results of the whole blood precision using the i-STAT 1 Wireless Analyzer are shown in Table 2.
8
| Table 2: Whole Blood Precision Results – i-STAT 1 System | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Within-Analyzer | Total | |||||||||
| i-STAT Test | Level | Site | N | Mean | SD | %CV | SD | SD 95% CI | %CV | %CV 95% CI |
| 01 | 21 | 95.3 | 0.98 | 1.0 | 0.98 | 0.81 to 1.39 | 1.0 | 0.8 to 1.5 | ||
| 01 | 21 | 72.3 | 1.23 | 1.7 | 1.23 | 1.03 to 1.75 | 1.7 | 1.4 to 2.4 | ||
| 02 | 21 | 95.1 | 0.90 | 0.9 | 0.90 | 0.75 to 1.27 | 0.9 | 0.8 to 1.3 | ||
| 30-110 | 02 | 21 | 95.5 | 0.69 | 0.7 | 0.69 | 0.57 to 0.98 | 0.7 | 0.6 to 1.0 | |
| 02 | 21 | 80.0 | 0.38 | 0.5 | 0.38 | 0.31 to 0.63 | 0.5 | 0.4 to 0.8 | ||
| 03 | 21 | 101.3 | 0.76 | 0.8 | 0.76 | 0.61 to 1.17 | 0.8 | 0.6 to 1.2 | ||
| 03 | 21 | 87.8 | 0.58 | 0.7 | 0.58 | 0.47 to 0.86 | 0.7 | 0.5 to 1.0 | ||
| 03 | 21 | 98.9 | 0.58 | 0.6 | 0.63 | 0.50 to 1.07 | 0.6 | 0.5 to 1.1 | ||
| Glucose | ||||||||||
| (mg/dL) | 01 | 21 | 148.2 | 0.62 | 0.4 | 0.62 | 0.51 to 0.88 | 0.4 | 0.3 to 0.6 | |
| 111-150 | 02 | 20 | 143.0 | 0.85 | 0.6 | 0.85 | 0.70 to 1.22 | 0.6 | 0.5 to 0.9 | |
| 02 | 14 | 143.3 | 1.25 | 0.9 | 1.25 | 1.06 to 2.03 | 0.9 | 0.7 to 1.4 | ||
| 03 | 21 | 142.2 | 0.79 | 0.6 | 0.79 | 0.65 to 1.12 | 0.6 | 0.5 to 0.8 | ||
| 01 | 21 | 385.7 | 2.38 | 0.6 | 2.98 | 2.33 to 5.40 | 0.8 | 0.6 to 1.4 | ||
| 151-400 | 02 | 21 | 318.0 | 3.25 | 1.0 | 3.25 | 2.70 to 4.62 | 1.0 | 0.8 to 1.5 | |
| 03 | 21 | 151.8 | 1.02 | 0.7 | 1.02 | 0.83 to 1.57 | 0.7 | 0.5 to 1.0 | ||
| 01 | 21 | 618.4 | 7.95 | 1.3 | 7.95 | 6.54 to 11.67 | 1.3 | 1.1 to 1.9 | ||
| 401-700 | 02 | 21 | 444.2 | 2.23 | 0.5 | 2.23 | 1.85 to 3.14 | 0.5 | 0.4 to 0.7 | |
| 03 | 21 | 582.0 | 2.82 | 0.5 | 2.93 | 2.33 to 4.84 | 0.5 | 0.4 to 0.8 | ||
| 01 | 21 | 0.82 | 0.038 | 4.6 | 0.044 | 0.035 to 0.078 | 5.4 | 4.3 to 9.5 | ||
| 01 | 21 | 0.60 | 0.038 | 6.3 | 0.038 | 0.031 to 0.053 | 6.3 | 5.2 to 8.8 | ||
| 12 | 02 | 21 | 14.90 | 0.515 | 3.5 | 0.515 | 0.427 to 0.732 | 3.5 | 2.9 to 4.9 | |
| 03 | 21 | 14.30 | 0.558 | 3.9 | 0.558 | 0.462 to 0.795 | 3.9 | 3.2 to 5.6 |
9
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 Glucose and Creatinine tests on the i-STAT 1 Analyzer were evaluated by preparing whole blood samples of varying analyte levels that spanned the reportable range of the test. The best fitting regression model was the third order model. The absolute degree of nonlinearity results met the acceptance criteria for each of the levels tested for each analyte. Therefore, the i-STAT Glucose and Creatinine test demonstrated linearity over the reportable range as shown in Table 3. Regression summary of the Glucose and Creatinine response versus the concentration of the whole blood samples of varying analyte levels is also provided in Table 3.
| Table 3: Regression Summary for the i-STAT tests on the i-STAT 1 Analyzer | |||||
|---|---|---|---|---|---|
| i-STAT Test | Reportable Range | Range Tested | Slope | Intercept | R2 |
| Glucose (mg/dL) | 20-700 | 17 - 620 | 0.9794 | -1.603 | 0.9991 |
| Creatinine (mg/dL) | 0.20 – 20.0 | 0.13 - 16.2 | 1.021 | 0.0763 | 0.9978 |
c. Limit of Quantitation (LoO)
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 Glucose and Creatinine tests were evaluated on the i-STAT 1 Analyzer using whole blood that was altered to low glucose (500 mmHg for creatinine and 25 to >500 mmHg for glucose.
g. Altitude
The results of the study show equivalent creatinine results at elevations up to 6367 feet and for glucose up to 9523 feet. The correlation coefficient and slope results from the Passing-Bablok regression analysis met the acceptance criteria as summarized as shown in Table below.
| Test | Average Measured
Altitude | Results |
|------------|------------------------------|----------------------|
| Creatinine | 6367 feet | r 1.00
Slope 1.13 |
| Glucose | 9523 feet | r 1.00
Slope 1.00 |
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h. Interference
The interference performance of the i-STAT Glucose and Creatinine tests on the i-STAT 1 Analyzer 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 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 allowed error (Ea) for the i-STAT test.
Table 6 and Table 7 contain the lists of potentially interfering substances tested for the i-STAT Glucose and Creatinine tests and the interference results.
| Table 6: Summary of Substance Tested and Interference Results for the i-STAT Glucose
| test | ||||
|---|---|---|---|---|
| Substance | Test Concentration | Interference | Interference | |
| mmol/L | mg/dL | (Yes/No) | Results | |
| Acetaldehyde | 0.045a | 0.2 | No | |
| Acetaminophen | 1.03 | 15.6 | No | |
| Lithium Acetoacetate | 2.0 | 20 | No | |
| N-Acetyl-L-Cysteine | 0.92 | 15.0 | No | |
| Ammonium Chloride | 2.0a | 10.70 | No | |
| L-Ascorbic Acid | 0.298 | 5.25 | No | |
| Bilirubin | 0.684 | 40 | No | |
| Lithium Bromide | 37.5a | 325.69 | Yes | Decreased results |
| ≥ 11.8 mmol/L | ||||
| Cholesterol | 10.3 | 400 | No | |
| Creatinine | 1.326 | 15 | No | |
| Dopamine Hydrochloride | 4.06 µmol/L | 0.0621 | No | |
| Ethanol | 130 | 600 | No | |
| Lithium Fluoride | 0.0632 | 0.12 | No | |
| Formaldehyde | 0.133a | 0.399 | No | |
| Fructose | 1 | 18 | No | |
| Galactose | 3.33 | 60 | No | |
| Gentamicin Sulfate | 0.0628 | 3 | No | |
| Glucosamine Hydrochloride | 0.030a | 0.647 | No | |
| Glutathione, reduced | 3 | 3 mEq/L | No | |
| Glycolic Acid | 10.0a | 76.05 | No |
i-STAT Glucose Test
a No CLSI EP37 test concentration available. 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.
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| test | ||||
|---|---|---|---|---|
| Substance | Test Concentration | Interference | Interference | |
| mmol/L | mg/dL | (Yes/No) | Results | |
| Guaifenesin | 0.0227 | 0.45 | No | |
| Hemoglobin | 10 g/L | 1000 | No | |
| Sodium Heparin | 3.30 U/mL | 330 U/dL | No | |
| β-Hydroxybutyric Acid | 6.0aa | 62.47 | No | |
| Hydroxyurea | 0.405 | 3.08 | Yes | Increased results |
| ≥ 0.08 mmol/L | ||||
| Ibuprofen | 1.06 | 21.9 | No | |
| Isoniazid | 0.438 | 6 | No | |
| Lithium Lactate | 10 | 90 | No | |
| Mannose | 1.0a | 18.02 | No | |
| Maltose | 10.5 | 360 | No | |
| pH | 8.0 pH units | N/A | No | |
| Lithium Pyruvate | 0.570 | 5 | No | |
| Lithium Salicylate | 0.207 | 2.86 | No | |
| Lithium Thiocyanate | 0.898 | 5.22 | No | |
| Sodium Thiosulfate | 16.7a | 264.04 | No | |
| Triglyceride | 16.94 | 1500 | No | |
| Uric Acid | 1.4 | 23.5 | No | |
| Xylose | 3a | 45.04 | No | |
| Gentisic Acid | 0.0973 | 1.50 | No |
| Table 6: Summary of Substance Tested and Interference Results for the i-STAT Glucose
i-STAT Creatinine Test
| Table 7: Summary of Substance Tested and Interference Results for the i-STAT
| Creatinine test | |||||
|---|---|---|---|---|---|
| Substance | Test Concentration | Interference | Interference | ||
| mmol/L | mg/dL | (Yes/No) | Results | ||
| Acetaldehyde | 0.045a | 0.2 | No | ||
| Acetaminophen | 1.03 | 15.6 | No | ||
| N-Acetyl-L-Cysteine | 0.92 | 15.0 | No | ||
| L-Ascorbic Acid | 0.298 | 5.25 | No | ||
| β-Hydroxybutyric Acid | 6.0a | 62.47 | No | ||
| Bicarbonate | 35.0 | 294.0 | No | ||
| Bilirubin | 0.684 | 40 | No | ||
| Lithium Bromide | 37.5a | 325.69 | Yes | Increased results | |
| ≥ 18.3 mmol/L | |||||
| Calcium Chloride | 5.0 | 20 | No | ||
| Creatine | 0.382a | 5.01 | No | ||
| Dopamine Hydrochloride | 4.06 umol/L | 0.0621 | No | ||
| Formaldehyde | 0.133a | 0.399 | No |
a No CLSI EP37 test concentration available. 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.
13
| Table 7: Summary of Substance Tested and Interference Results for the I-STAT Creatinine test | ||||
|---|---|---|---|---|
| Substance | Test Concentration | Interference (Yes/No) | Interference Results | |
| mmol/L | mg/dL | |||
| Glycolic Acid | 10.0a | 76.05 | No | |
| Hemoglobin | 10 g/L | 1000 | No | |
| Hydroxyurea | 0.405 | 3.08 | Yes | Increased results |
| ≥ 0.03 mmol/L | ||||
| Lithium Lactate | 10 | 90 | No | |
| Methyldopa | 107 $ μ $ mol/L | 2.25 | No | |
| pH | 8.0 pH units | N/A | No | |
| Lithium Pyruvate | 0.570 | 5 | No | |
| Lithium Salicylate | 0.207 | 2.86 | No | |
| Sodium Thiosulfate | 16.7a | 264.04 | No | |
| Triglyceride | 16.94 | 1500 | No | |
| Uric Acid | 1.4 | 23.5 | No |
| Table 7: Summary of Substance Tested and Interference Results for the i-STAT
Comparison Study
Method Comparison with Predicate Device i.
Method comparison was demonstrated in a study comparing the i-STAT Glucose and Creatinine test performance on the i-STAT 1 to the Beckman DxC. The study was based on CLSI guideline EP09c-ED3. Venous and arterial blood specimens were evaluated and analyzed on the i-STAT 1 against plasma specimens on the Beckman DxC. A Passing-Bablok linear regression analysis was performed using the first replicate result from the i-STAT 1 versus the singlicate 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 (OCC) 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 OCCs 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 5: Method Comparison Results | |||||
|---|---|---|---|---|---|
| i-STAT Test | N | Slope | Intercept | r | |
| Glucose | 185 | 0.98 | 0.00 | 1.00 | |
| Creatinine | 180 | 1.043 | -0.062 | 1.00 |
8. Conclusion
The results of these studies demonstrate that performance of the i-STAT CHEM8+ Glucose and Creatinine tests with the i-STAT 1 System are substantially equivalent to the comparative method.