(266 days)
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No
The summary describes a standard in vitro diagnostic device that uses biosensors and fluidics to measure analytes. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description or performance studies.
No
This device is an in vitro diagnostic (IVD) device used for the quantitative measurement of various analytes in blood, aiding in the diagnosis of conditions like anemia. It is not used for treating or preventing diseases.
Yes
The "Intended Use / Indications for Use" section states: "Hematocrit measurements can aid in the determination of normal or abnormal total red cell volume status that can be associated with conditions including anemia and erythrocytosis," and "For in vitro diagnostic use." The "Device Description" also explicitly calls it an "in vitro diagnostic analytical device." These statements confirm its role in diagnosing medical conditions.
No
The device description explicitly states the system is comprised of hardware components including an instrument, rechargeable battery, base station, electronic simulator, control material, printer, and test cartridges.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use."
- Device Description: The "Device Description" section describes the i-STAT Alinity System as a "handheld, in vitro diagnostic analytical device."
- Intended Use: The device is intended for the "quantitative measurement of various analytes in arterial and venous whole blood" and specifically 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." This involves testing biological samples (blood) outside of the body to provide diagnostic information.
- Clinical Context: The results are intended to "aid in the determination of normal or abnormal total red cell volume status that can be associated with conditions including anemia and erythrocytosis," which is a clear diagnostic purpose.
- Care Setting and User: It's intended for use in "point of care or clinical laboratory settings" by "trained medical professionals," which aligns with the typical use of IVD devices.
N/A
Intended Use / Indications for Use
The i-STAT Alinity instrument with i-STAT tests is intended for use in point of care or clinical laboratory settings. The i-STAT Alinity system is intended for the quantitative measurement of various analytes in arterial and venous whole blood.
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 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 Hematocrit test with the i-STAT Alinity System is not for use with capillary samples.
For in vitro diagnostic use.
Product codes (comma separated list FDA assigned to the subject device)
JPI, JGS
Device Description
The i-STAT Alinity System is a handheld, in vitro diagnostic analytical device designed to run i-STAT test cartridges. The system is designed for use at or near point of patient care, by trained medical professionals and is for prescription use only.
The i-STAT Alinity System is comprised of the instrument, rechargeable battery, base station, electronic simulator, control material, printer and i-STAT test cartridges. The i-STAT Alinity Instrument features a barcode scanner, user interface with touch screen display and wireless capability. The instrument reports quantitative results within approximately 2 minutes.
The i-STAT test cartridge contains sensors which are located on the biosensors chips. The instrument interacts with the cartridge to move fluid across the sensors and generate a quantitative result. Cartridges require two to three drops of whole blood which are typically applied to the cartridge using a syringe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
The i-STAT Hematocrit test with the i-STAT Alinity System has not been evaluated in neonates.
Intended User / Care Setting
trained medical professionals / point of care or clinical laboratory settings
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)
a. Precision:
- Study Type: 20-day Precision (aqueous materials) based on CLSI document EP5-A3.
- Sample Size: 4 levels of aqueous materials, 80 measurements per level.
- Key Results: CV L2 (Mean: 16.9%PCV, ST: 0.46%PCV, CVT: 2.72%), CV L3 (Mean: 33.9%PCV, ST: 0.51%PCV, CVT: 1.50%), CV L4 (Mean: 55.2%PCV, ST: 0.49%PCV, CVT: 0.89%), CV L5 (Mean: 65.0%PCV, ST: 0.39%PCV, CVT: 0.60%).
- Study Type: Precision (whole blood)
- Sample Size: Venous whole blood samples (native or altered) at low, normal, and high hematocrit levels. Each sample tested 3 times on each of 7 i-STAT Alinity Instruments (total of 21 test results per sample) across 3 point of care sites.
- Key Results: Within-Instrument SD and %CV, and Total SD and %CV for different hematocrit levels across sites (e.g., 51% PCV). Max total CV was 1.49%.
b. Linearity:
- Study Type: Linearity study based on CLSI EP06-A.
- Sample Size: Whole blood samples with hematocrit levels spanning the reportable range (15 - 75 %PCV).
- Key Results: Demonstrated linearity of the i-STAT Hematocrit test over the reportable range. The best fitting regression model was a third order model, and the absolute value of the non-linearity ranged from 0.19 to 0.81 %PCV.
c. Recovery:
- Study Type: Recovery study.
- Sample Size: A series of whole blood samples with hematocrit levels spanning the reportable range.
- Key Results: The % recovery ranged from 100.1% to 102.8%.
d. Limit of Quantitation (LoQ):
- Study Type: LoQ study based on CLSI EP17-A2.
- Sample Size: Whole blood samples altered to low hematocrit levels (12 g/dL for 26.5 - 31.5% PCV, White Blood Cells at > 50,000 WBC/µL for 26.5 - 31.5% PCV). Bromide (37.5 mmol/L) is an interferent with the sodium test and it may result in an increased rate of star outs (***) for the hematocrit test.
f. Anticoagulant Study:
- Study Type: Sample type comparison study.
- Sample Size: 40 blood samples spanning the reportable range, 15 to 75 %PCV.
- Key Results: Deming regression results showed a slope of 1.00 and a correlation coefficient of 1.00 when comparing heparinized whole blood to non-anticoagulated whole blood.
g. Microhematocrit Reference Study:
- Study Type: Microhematocrit reference study.
- Sample Size: 40 lithium heparinized whole blood samples spanning 15 to 75 %PCV.
- Key Results: Deming regression of i-STAT Hematocrit results (traceable to K2EDTA reference) to K2EDTA microhematocrit results gave a slope of 1.02, an intercept of -0.53 and a coefficient of determination (R2) of 1.00. Another Deming regression (traceable to K2EDTA reference) to K2EDTA microhematocrit results gave a slope of 1.02, an intercept of -0.41 and a coefficient of determination (R2) of 1.00.
h. Method Comparison with Predicate Device:
- Study Type: Method comparison.
- Sample Size: 240 whole blood (venous or arterial) samples covering the reportable range, 15 to 75 %PCV.
- Key Results: The Weighted Deming regression for all 3 sites combined had a regression slope of 1.016 and correlation coefficient (r) of 0.995, comparing to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are depicted in a simple, flowing line style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2017
Abbott Point of Care, Inc. Laura Y. Joglekar Associate Director, Regulatory Affairs 400 College Road East Princeton, NJ 08540
Re: K163342
Trade/Device Name: i-STAT Hematocrit test with i-STAT Alinity System Regulation Number: 21 CFR 864.6400 Regulation Name: Hematocrit measuring device Regulatory Class: Class II Product Code: JPI Dated: July 24, 2017 Received: July 25, 2017
Dear Ms. Joglekar:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Leonthena R. Carrington -S
Lea Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K163342
Device Name
i-STAT Hematocrit test with the i-STAT Alinity System
Indications for Use (Describe)
The i-STAT Alinity instrument with i-STAT tests is intended for use in point of care or clinical laboratory settings. The i-STAT Alinity system is intended for the quantitative measurement of various analytes in arterial and venous whole blood.
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 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 Hematocrit test with the i-STAT Alinity System is not for use with capillary samples.
For in vitro diagnostic use.
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: Laura Joglekar |
| Associate Director, Regulatory Affairs | |
| laura.joglekar@abbott.com | |
| Phone: 609-454-9327 |
Secondary: Susan Tibedo
Director, Regulatory Affairs
susan.tibedo@abbott.com
Phone: 609-454-9360 |
| Date Prepared | July 24, 2017 |
2. Device Information
Proprietary Name
i-STAT Hematocrit test with the i-STAT Alinity System
| Product
code | Device Classification
name | Regulation
Number | Class | Panel |
|-----------------|------------------------------------|----------------------|-------|--------------------|
| JPI | Device, Hematocrit
Measuring | 864.6400 | II | Hematology |
| JGS | Electrode, Ion Specific,
Sodium | 862.1665 | II | Clinical Chemistry |
3. Predicate Device
Proprietary Name 510(k) Number
i-STAT Hematocrit test with i-STAT 1 Wireless Analyzer K103195
| Product
code | Device Classification
name | Regulation
Number | Class | Panel |
|-----------------|---------------------------------|----------------------|-------|------------|
| JPI | Device, Hematocrit
Measuring | 864.6400 | II | Hematology |
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4. Device Description
The i-STAT Alinity System is a handheld, in vitro diagnostic analytical device designed to run i-STAT test cartridges. The system is designed for use at or near point of patient care, by trained medical professionals and is for prescription use only.
The i-STAT Alinity System is comprised of the instrument, rechargeable battery, base station, electronic simulator, control material, printer and i-STAT test cartridges. The i-STAT Alinity Instrument features a barcode scanner, user interface with touch screen display and wireless capability. The instrument reports quantitative results within approximately 2 minutes.
The i-STAT test cartridge contains sensors which are located on the biosensors chips. The instrument interacts with the cartridge to move fluid across the sensors and generate a quantitative result. Cartridges require two to three drops of whole blood which are typically applied to the cartridge using a syringe.
5. Intended Use Statement
Instrument
The i-STAT Alinity instrument with i-STAT tests is intended for use in point of care or clinical laboratory settings. The i-STAT Alinity system is intended for the quantitative measurement of various analytes in arterial and venous whole blood. For in vitro diagnostic use.
Test
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 nonanticoagulated 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 Hematocrit test with the i-STAT Alinity System is not for use with capillary samples.
5
| Similarities and Differences: System (Test and Instrument) | ||
|---|---|---|
| Feature or | ||
| Characteristic | Predicate Device (K103195): | |
| i-STAT Hematocrit test with | ||
| the i-STAT1 Wireless Analyzer | Candidate Device: | |
| i-STAT Hematocrit test with | ||
| the i-STAT Alinity instrument | ||
| Intended Use: | ||
| Instrument | The i-STAT 1 Wireless Analyzer | |
| is used by trained medical | ||
| professionals for running a | ||
| variety of clinical chemistry tests | ||
| and test panels contained in | ||
| i-STAT test cartridges. | The i-STAT Alinity instrument | |
| with i-STAT tests is intended for | ||
| use in point of care or clinical | ||
| laboratory settings. The i-STAT | ||
| Alinity system is intended for the | ||
| quantitative measurement of | ||
| various analytes in arterial and | ||
| venous whole blood. |
For in vitro diagnostic use. |
| Intended Use:
Test | The test for hematocrit, as part of
the i-STAT System, is intended
for use in the in vitro
quantification of packed red
blood cell volume fraction in
arterial, venous, or capillary
whole blood. | 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 including, but not limited
to, conditions such as anemia,
erythrobytosis, and blood loss
related to trauma a surgery. | 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 Hematocrit test with
the i-STAT Alinity System is not
for use with capillary samples. |
| Similarities and Differences: System (Test and Instrument) | | |
| Feature or
Characteristic | Predicate Device (K103195):
i-STAT Hematocrit test with
the i-STAT1 Wireless Analyzer | Candidate Device:
i-STAT Hematocrit test with
the i-STAT Alinity instrument |
| Principle of
Measurement | Hematocrit is measured using the
conductivity method. | Same |
| Calibration | 1-point on-board (contained
within the cartridge) | Same |
| Test
Traceability | Microhematocrit Method | Same |
| Test Reportable
Range | 15 – 75 %PCV | Same |
| Sample Type | Fresh capillary, arterial or venous
whole blood. | Fresh arterial or venous whole
blood. |
| Sample Volume | 65 - 95 μL | Same |
| Time to test | ~2 minutes | Same |
| Test Format | Cartridge | Same |
| Test preparation | Ready to use | Same |
| Test Storage
and Stability | Storage: 2°C to 8°C (35-46°F) | Same |
| Quality Checks | A series of quality checks are
automatically run each test cycle
prior to the system generating a
result. Quality checks verify the
analyzer motor, electrical,
pressure and temperature systems
and cartridge elements. | Same |
| Wireless
connectivity
capability | Yes | Same |
| Power | Two 9-volt lithium batteries, or
rechargeable battery. | Lithium-Ion rechargeable battery |
6. Summary Comparision of Technological Characteristics
6
7
| Similarities and Differences: System (Test and Instrument) | |||||||
|---|---|---|---|---|---|---|---|
| Feature or | |||||||
| Characteristic | Predicate Device (K103195): | ||||||
| i-STAT Hematocrit test with | |||||||
| the i-STAT1 Wireless Analyzer | Candidate Device: | ||||||
| i-STAT Hematocrit test with | |||||||
| the i-STAT Alinity instrument | |||||||
| Barcode | |||||||
| scanning | |||||||
| capability | Yes | Same | |||||
| Data storage | |||||||
| capability | Yes | Same | |||||
| User Interface | 19 keys for data entry | LCD touch screen | |||||
| User Interface | |||||||
| Screen | A grey scale LCD (3.5 in.) | A color LCD screen (5 in.) |
7. Performance Characteristics
a. Precision
Precision 20 days (aqueous materials)
The precision of the i-STAT Hematocrit test on the i-STAT Alinity Instrument was evaluated using 4 levels of aqueous materials. This 20-day precision testing was based on CLSI document EP5-A3: Evaluation of Quantitative Measurement Procedures; Approved Guideline – Third Edition. The study was conducted using 10 instruments and one test cartridge lot over 20 days at one site. The results of the 20-day precision study using all test results are shown in Table 1.
| Fluid | N | Mean
(%PCV) | ST
(%PCV) | CVT | Sr
(%PCV) | CVr | Srr
(%PCV) | CVrr | Sdd
(%PCV) | CVdd |
|-------|----|----------------|--------------|-------|--------------|-------|---------------|-------|---------------|-------|
| CV L2 | 80 | 16.9 | 0.46 | 2.72% | 0.44 | 2.60% | 0.09 | 0.53% | 0.09 | 0.53% |
| CV L3 | 80 | 33.9 | 0.51 | 1.50% | 0.48 | 1.42% | 0.13 | 0.38% | 0.11 | 0.32% |
| CV L4 | 80 | 55.2 | 0.49 | 0.89% | 0.47 | 0.85% | 0.12 | 0.22% | 0.09 | 0.16% |
| CV L5 | 80 | 65.0 | 0.39 | 0.60% | 0.37 | 0.57% | 0.10 | 0.15% | 0.09 | 0.14% |
Table 1: 20-day Precision Study Results
Precision (whole blood)
The whole blood precision of the i-STAT Hematocrit Test on the i-STAT Alinity Instrument was evaluated using venous whole blood (native or altered) samples targeted to be within a low abnormal, normal and high abnormal hematocrit levels.
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 Alinity Instruments (total of 21 test results per sample). The results of the whole blood precision study are shown in Table 2.
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| Level (%PCV) | Site | N | Mean
(%PCV) | Within-Instrument | | Total | |
|-------------------------|------|----|----------------|-------------------|------|-------|------|
| | | | | SD | %CV | SD | %CV |
| 51
(abnormal high) | 1 | 21 | 54.9 | 0.44 | 0.80 | 0.48 | 0.88 |
| | 2 | 21 | 53.1 | 0.30 | 0.57 | 0.30 | 0.57 |
| | 4 | 21 | 53.0 | 0.22 | 0.41 | 0.22 | 0.41 |
Table 2: Whole Blood Precision Results
b. Linearity
The study was based on CLSI EP06-A: Evaluation of the linearity of quantitative measurement procedures; Approved Guideline. The linearity of the i-STAT Hematocrit test was evaluated on the i-STAT Alinity Instrument by preparing a series of whole blood samples with hematocrit levels that spanned the reportable range of the test. The best fitting regression model was a third order model, and the absolute value of the non-linearity ranged from 0.19 to 0.81 %PCV. The linearity of the i-STAT Hematocrit test used with the i-STAT Alinity Instruments was demonstrated over the reportable range (15 - 75 %PCV).
c. Recovery
The recovery of the i-STAT Hematocrit test was evaluated on the i-STAT Alinity Instrument by by preparing a series of whole blood samples with hematocrit levels that spanned the reportable range of the test, measuring their expected value on the predicate device and determining the % recovery. The % recovery ranged from 100.1% to 102.8%.
d. 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 Hematocrit test was evaluated on the i-STAT Alinity Instrument using whole blood samples that were altered to low hematocrit levels ( 10.8% of the mean reference value. Compounds that do not interfere with
i-STAT Hematocrit Test with the i-STAT Alinity System
9
the hematocrit test are shown in Table 3; those compounds that do interfere are shown in Table 4.
| Compound | Test Concentration
(mmol/L) | Test Concentration
(mg/dL) |
|--------------------|--------------------------------|-------------------------------|
| Bromide** | 12 (g/dL) | 26.5 - 31.5* | Interfering |
| Total Protein
(human serum albumin) | >12 (g/dL) | 57 - 63** | Non-interfering |
| White Blood Cells | > 50,000
WBC/µL | 26.5 - 31.5 * | Interfering |
*Concentrations greater than the test concentrations do interfere
**Concentrations less than the test concentrations do not interfere
f. Anticoagulant Study
The sample type comparison study was performed using the i-STAT Hematocrit test on the i-STAT Alinity Instrument and 40 blood samples spanning the reportable range, 15 to 75 %PCV. The comparator condition for this study was heparinized whole blood and the test condition was non-anticoagulated whole blood. The Deming regression results were a slope of 1.00 and a correlation coefficient of 1.00.
g. Microhematocrit Reference Study
The microhematocrit reference study was performed using the i-STAT Hematocrit test on the i-STAT Alinity Instrument and 40 lithium heparinized whole blood samples spanning the reportable range, 15 to 75 %PCV. Two comparator conditions for this study were used: the K2EDTA and K2EDTA microhematocrit results for the 40 whole blood samples. The Deming regression of the i-STAT Hematocrit results (traceable to K2EDTA reference) to the K2EDTA microhematocrit results gave a slope of 1.02, an intercept of -0.53 and a coefficient of
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determination (R2) of 1.00.The Deming regression of the i-STAT Hematocrit results (traceable to K2EDTA reference) to the K2EDTA microhematocrit results gave a slope of 1.02, an intercept of -0.41 and a coefficient of determination (R2) of 1.00.
h. Method Comparison with Predicate Device
The method comparison study compared the clinical results of the i-STAT Hematocrit test on the i-STAT Alinity Instrument to the results of the i-STAT Hematocrit test on the i-STAT 1 Wireless Analyzer (predicate). The study was conducted across 3 point of care sites. The study included 240 whole blood (venous or arterial) samples covering the reportable range, 15 to 75 %PCV. The Weighted Deming regression for all 3 sites combined had a regression slope of 1.016 and correlation coefficient (r) of 0.995.
8. Conclusion
Analytical and clinical studies have shown the i-STAT Hematocrit test with the i-STAT Alinity System to be safe and effective for its intended use. The results of these studies demonstrate that performance of the i-STAT Hematocrit test with the i-STAT Alinity System is substantially equivalent to the predicate device.