(427 days)
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.
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.
The medical device discussed in these documents is the i-STAT CHEM8+ cartridge with the i-STAT 1 System for measuring hematocrit.
Here's a breakdown of the acceptance criteria and the study information, structured as requested:
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Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria (Performance Metric) Acceptance Criteria Reported Device Performance Precision (Aqueous Materials) Not explicitly stated as acceptance criteria, but study results presented for various levels. CV L2/Control L1: 1.1% Precision (Whole Blood) - Venous Not explicitly stated as acceptance criteria, but study results presented for various ranges. ≤ 35%PCV: 1.6% CV Precision (Whole Blood) - Arterial Not explicitly stated as acceptance criteria, but study results presented for various ranges. ≤ 35%PCV: 7.1% CV Linearity Absolute degree of nonlinearity results meet acceptance criteria. Demonstrated linearity over 15 - 75 %PCV. (Regression R² = 0.9973) Limit of Quantitation (LoQ) LoQ must be below the lower limit of the reportable range. LoQ = 12.4 %PCV (below reportable range of 15%PCV) Limit of Blank (LoB) Not explicitly stated as a numerical acceptance criteria. LoB = 0.66 %PCV Limit of Detection (LoD) Not explicitly stated as a numerical acceptance criteria. LoD = 1.38 %PCV Interference 95% CI of the difference between test & control samples must be within allowable error (Ea). Most substances showed no interference. Lithium Bromide, Total Protein (high/low), and White Blood Cells (>50,000 WBC/uL) showed interference. Method Comparison (Slope vs. Predicate) Not explicitly stated as a numerical acceptance criteria. 1.030 Method Comparison (Intercept vs. Predicate) Not explicitly stated as a numerical acceptance criteria. -0.530 Method Comparison (Correlation vs. Predicate) Not explicitly stated as a numerical acceptance criteria. 1.00 -
Sample Size Used for the Test Set and Data Provenance
- Precision (Aqueous Materials): N=80-81 for each of the 4 levels. Data provenance not specified (likely internal laboratory data).
- Precision (Whole Blood): 190 samples (123 venous, 67 arterial). Data collected across three point-of-care sites. Data provenance not specified (implies retrospective collection from clinical sites).
- Linearity: Whole blood samples of varying analyte levels. Number of samples not specified. Data provenance not specified.
- Limit of Quantitation: Four whole blood samples. Study conducted over 3 days using 2 cartridge lots. Data provenance not specified.
- Limit of Blank/Detection: Whole blood samples (one "blank" and two "low" Hct concentrations). Data provenance not specified.
- Interference: Whole blood test samples. Number of samples not specified for each substance. Data provenance not specified.
- Method Comparison: N=194 (venous and arterial blood specimens). Data provenance not specified (implies collection at sites performing method comparison).
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- No information provided regarding the use of experts to establish a "ground truth" in the traditional sense. These are analytical performance studies, where the reference method (e.g., predicate device, microhematocrit method) serves as the comparator or reference.
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Adjudication Method for the Test Set
- Not applicable/Not mentioned. These are objective analytical measurements compared against established reference methods or statistical criteria, not subjective interpretations requiring adjudication.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- Not applicable. This device is an in-vitro diagnostic (IVD) instrument for quantitative measurement of hematocrit, not an AI imaging or diagnostic algorithm that assists human readers.
-
If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- Yes, the entire submission focuses on the standalone analytical performance of the i-STAT CHEM8+ cartridge with the i-STAT 1 System, a fully automated measurement device. There is no human-in-the-loop component in the measurement itself, beyond loading the sample and operating the device.
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The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Analytical Performance: The ground truth or reference method for analytical performance studies is implicitly or explicitly stated.
- Precision: Statistical variability of repeated measurements.
- Linearity: Expected values based on dilutions or known concentrations.
- LoQ/LoB/LoD: Statistical determination from low-level samples.
- Interference: Comparison of spiked samples to unspiked controls.
- Method Comparison: The predicate device (i-STAT Hematocrit test on the i-STAT Alinity Instrument) was used as the comparative method. The "Test Traceability" section also notes the Microhematocrit Method as the basis for traceability.
- Analytical Performance: The ground truth or reference method for analytical performance studies is implicitly or explicitly stated.
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The Sample Size for the Training Set
- Not applicable. This device is a quantitative measurement system, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its performance is based on its electrochemical sensing mechanisms and calibration, rather than on parameters learned from a data set.
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How the Ground Truth for the Training Set Was Established
- Not applicable, as no training set (for machine learning) is relevant to this device.
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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.
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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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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 EastPrinceton, NJ 08540 | |
| Contact | Primary: Susan TibedoDirector Regulatory Affairssusan.tibedo@abbott.comPhone: 609-454-9360Secondary: Maria FigueroaManager Regulatory Affairsmaria.l.figueroa@abbott.comPhone: 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
| Productcode | Device Classificationname | RegulationNumber | Class | Panel |
|---|---|---|---|---|
| JPI | Device, HematocritMeasuring | 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
| Productcode | Device Classificationname | RegulationNumber | Class | Panel |
|---|---|---|---|---|
| JPI | Device, HematocritMeasuring | 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 orCharacteristic | Predicate Device (K163342):i-STAT Hematocrit test on the i-STATEC4+ cartridge with thei-STAT Alinity System | Candidate Device:i-STAT Hematocrit test with the i-STAT1 System |
| Intended Use | The i-STAT Hematocrit test is intendedfor use in the in vitro quantification ofpacked red blood cell volume fraction inarterial or venous heparinized wholeblood, or in arterial or venous non-anticoagulated whole blood.Hematocrit measurements can aid in thedetermination and monitoring of normal orabnormal total red cell volume status thatcan be associated with conditionsincluding anemia and erythrocytosis.The i-STAT Hematocrit test with thei-STAT Alinity System has not beenevaluated in neonates. | The i-STAT CHEM8+ cartridge withthe i-STAT 1 System is intended foruse in the in vitro quantification ofhematocrit in arterial or venous wholeblood in point of care or clinicallaboratory settings.Hematocrit measurements can aid inthe determination and monitoring ofnormal or abnormal total red cellvolume status that can be associatedwith conditions including anemia anderythrocytosis.The i-STAT Hematocrit test has not |
| Similarities and Differences | ||
| Feature orCharacteristic | Predicate Device (K163342):i-STAT Hematocrit test on the i-STATEC4+ cartridge with thei-STAT Alinity System | Candidate Device:i-STAT Hematocrit test with the i-STAT1 System |
| The i-STAT Hematocrit test with thei-STAT Alinity System is not for use withcapillary samples. | been evaluated in neonates. | |
| ReportableRange | 15 - 75 %PCV | Same |
| Sample Type | Arterial or venous whole blood | Arterial or venous whole blood |
| SampleVolume | 65 μL | 95 μL |
| Samplepreparation | Ready to use | Same |
| TestTraceability | Microhematocrit Method | Same |
| Calibration | 1-point on-board (contained within thecartridge) | Same |
| Analysis Time | ~2 minutes | Same |
| Principle ofMeasurement | Hematocrit is measured using theconductivity method. | Same |
| ReagentFormat | Cartridge | Same |
| Storage andStability | Storage: 2°C to 8°C(35-46°F) | Same |
| CartridgeCase | White | Blue |
| Case thumbwell | 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 | ReportableRange (%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 (<15 %PCV). The study was conducted over three (3) days using two (2) cartridge lots. The LoQ for the i-STAT Hematocrit test was determined to be 12.4 %PCV, which is below the lower limit of the i-STAT Hematocrit test reportable range (15 - 75 %PCV).
d. Limit of Blank and Detection (LoB/LoD)
The study was based on CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline-Second Edition.
The LoB/LoD of the i-STAT Hematocrit test was evaluated on the i-STAT 1 Analyzer using whole blood that was altered to a "blank" hematocrit concentration for LoB testing and two "low" hematocrit concentrations for LoD testing. The LoB and LoD were determined based on the maximal LoB or LoD value obtained for each cartridge lot tested. The LoB the i-STAT Hematocrit test was determined to be 0.66 %PCV and
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the LoD was determined to be 1.38 %PCV.
e. Interference
The interference performance of the i-STAT Hematocrit test on the i-STAT 1 Analyzer was evaluated using whole blood test samples based on CLSI EP07-A2: Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition. The effect of each substance at each Hematocrit 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 95% confidence interval of the difference between the test sample and the control sample was not within the allowable error (Ea) for the i-STAT test.
Table 5 contains the list of potentially interfering substances tested for the i-STAT Hematocrit test and the interference results.
| Table 5: Substances Tested and Interference Results for the i-STAT Hct test | ||||
|---|---|---|---|---|
| Substance | Test Concentration1 | Interference(Yes/No) | Interference Results | |
| mmol/L | mg/dL | |||
| Bilirubin | 0.342 | 20 | No | |
| Intralipid | N/A | 5296 | No | |
| LithiumBromide | 37.5 | 325.69 | Yes | Lithium Bromide ≥ 14.0 mmol/L decreases Hct results. Use an alternate method. |
| Nithiodote(SodiumThiosulfate) | 16.7 | 264.04 | No | |
| Total Protein | 12 g/dL | 12000 | Yes | • Protein levels above normal (>8.0 g/dL) showed interference at 10.2 g/dL for Hct (<40% PCV)• Protein level below normal (<6.5 g/dL) showed interference at 5.3 g/dL for Hct (<40% PCV) |
| Triglyceride | 37 | 3233.8 | No | |
| White BloodCells | >50000WBC/uL* | >50000WBC/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.
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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.
§ 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.