(266 days)
The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of ionized calcium and hematocrit in arterial or venous whole blood in point of care or clinical laboratory settings.
The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of hematocrit in capillary whole blood in point of care or clinical laboratory settings.
Ionized calcium measurements are used in the diagnosis, monitoring, and treatment of conditions including, but not limited to, parathyroid disease, a variety of bone disease, chronic renal disease, tetany, and disturbances related to surgical and intensive care.
Hematocrit measurements can aid in the determination of normal or abnormal total red cell volume status that can be associated with conditions including anemia, erythrocytosis, and blood loss related to trauma and surgery.
The i-STAT CG8+ cartridge is used with the i-STAT 1 analyzer as part of the i-STAT 1 System and contains test reagents to measure hematocrit (Hct) in arterial, venous or capillary whole blood and to measure ionized calcium (iCa) in arterial and venous whole blood.
The i-STAT 1 System is an in vitro diagnostic (IVD) medical device intended for the quantitative determination of various clinical chemistry tests contained within i-STAT cartridges using whole blood. The i-STAT 1 System consists of a portable blood analyzer (i-STAT 1 analyzer), single-use disposable test cartridges (i-STAT cartridges), liquid quality control and calibration verification materials, and accessories (i-STAT 1 Downloader/Recharger, i-STAT Electronic Simulator and i-STAT 1 Printer). The i-STAT 1 System, including the i-STAT CG8+ cartridge, is designed for use by trained medical professionals in point of care or clinical laboratory settings and is for prescription use only.
The i-STAT CG8+ cartridge contains the required sensors, a fluid pack (calibrant pouch), a sample entry well and closure, fluid channels, waste chamber, and the necessary mechanical features for controlled fluid movement within cartridge. The i-STAT cartridge format allows all the tests in the cartridge to be performed simultaneously. All the test steps and fluid movement occur within the i-STAT CG8+ cartridges require two to three drops of whole blood which are applied to the cartridge using a transfer device by the trained user before the cartridge is placed within the analyzer.
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 i-STAT CG8+ cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes).
The provided text describes the analytical performance studies for the i-STAT CG8+ cartridge with the i-STAT 1 System, a device for in vitro quantification of ionized calcium (iCa) and hematocrit (Hct). This submission sought to demonstrate substantial equivalence to a predicate device (i-STAT CHEM8+ cartridge with the i-STAT 1 System, K191360).
Here's an analysis of the acceptance criteria and study details based on the provided information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state pre-defined acceptance criteria (e.g., target ranges for precision, linearity, or bias). Instead, it presents the results of various analytical performance studies. The conclusion states that the studies demonstrate substantial equivalence to the predicate device, implying that the reported performance metrics met the internal or regulatory thresholds for such a claim.
However, we can infer performance targets for some aspects by comparing the reported results to general expectations for such devices or by looking at the predicate device's characteristics mentioned (though the predicate's detailed performance is not provided in this document).
For the purpose of this request, I will present the reported performance values. The "Acceptance Criteria" column will reflect the general expectation of "demonstrating substantial equivalence" or meeting regulatory standards for the tested parameter, as specific numerical acceptance criteria are not provided in the document.
| Test Parameter | Acceptance Criteria (Inferred from "Substantial Equivalence") | Reported Device Performance (i-STAT CG8+ cartridge with i-STAT 1 System) |
|---|---|---|
| Precision (Aqueous Materials) - 20 Days | Performance demonstrating substantial equivalence to predicate. | iCa (mmol/L): Overall Within-Laboratory SD typically < 0.015 mmol/L, %CV < 0.8%. Hct (%PCV): Overall Within-Laboratory SD typically < 0.5%, %CV < 2%. (See Table 2 for full details) |
| Precision (Aqueous Materials) - Multi-site/Operator | Performance demonstrating substantial equivalence to predicate. | iCa (mmol/L): Overall SD typically < 0.02 mmol/L, %CV < 1%. Hct (%PCV): Overall SD typically < 0.5%, %CV < 3.5%. (See Table 3 for full details) |
| Precision (Whole Blood) | Performance demonstrating substantial equivalence to predicate. | iCa (mmol/L): SD typically < 0.022 mmol/L, %CV < 1.3%. Hct (%PCV): SD typically < 2.2%, %CV < 5.6%. (See Table 4 for full details) |
| Linearity (iCa) | Linear response over reportable range, demonstrating substantial equivalence. | Reportable Range: 0.25 - 2.50 mmol/L Range Tested: 0.204 - 2.832 mmol/L Slope: 1.016, Intercept: 0.019, R: 0.9981 (See Table 5) |
| Linearity (Hct) | Linear response over reportable range, demonstrating substantial equivalence. | Reportable Range: 15 - 75 %PCV Range Tested: 12.7 - 78.3 %PCV Slope: 1.031, Intercept: -0.592, R: 0.9992 (See Table 5) |
| Limit of Quantitation (LoQ) | LoQ at or below the lower limit of the reportable range. | iCa: Determined LoQ 0.15 mmol/L (Lower limit: 0.25 mmol/L) Hct: Determined LoQ 13 %PCV (Lower limit: 15 %PCV). (See Table 6) |
| Limit of Blank (LoB) | LoB consistent with low-end measurement expectations. | iCa: LoB 0.119 mmol/L Hct: LoB 0 %PCV (See Table 7) |
| Limit of Detection (LoD) | LoD consistent with low-end measurement expectations. | iCa: LoD 0.125 mmol/L Hct: LoD 0.4 %PCV (See Table 7) |
| Analytical Specificity (Interference) | Interference properties demonstrate substantial equivalence to predicate, with known interferences identified. | Various substances tested. Identified interferences for iCa: Bromide (dose-response needed), Lactate (≥6 mmol/L), Leflunomide (≥0.345 mmol/L), Magnesium (≥3.5 mmol/L), Nithiodote (≥5.3 mmol/L), Teriflunomide (≥0.049 mmol/L), Thiocyanate (≥0.898 mmol/L). Identified interferences for Hct: Bromide (dose-response needed), Total Protein (≥9.5 g/dL). (See Table 8) |
| Method Comparison (iCa) | Strong correlation and low bias against comparative method, demonstrating substantial equivalence. | Comparative Method: i-STAT CHEM8+ N: 343 Slope: 1.02, Intercept: -0.02, r: 0.99 Bias at MDLs: -0.009 to 0.003 mmol/L (See Table 9) |
| Method Comparison (Hct) | Strong correlation and low bias against comparative method, demonstrating substantial equivalence. | Comparative Method: i-STAT CHEM8+ / Epoc Blood Analysis System N: 535 Slope: 1.000, Intercept: -1.00, r: 0.98 Bias at MDLs: -1.0 %PCV (See Table 10) |
| Method Comparison (Capillary Hct only) | Strong correlation and low bias against comparative method, demonstrating substantial equivalence for capillary samples. | N: 208 Slope: 1.000, Intercept: 0.00, r: 0.97 Range: 18-73 %PCV Bias at MDLs (Native): 0.0 %PCV. (See Tables 11 & 12) |
| Matrix Equivalence (iCa) | Strong correlation between non-anticoagulated and anticoagulated samples. | N: 298 r: 0.99, Slope: 1.00, Intercept: 0.01 (See Table 13) |
| Matrix Equivalence (Hct) | Strong correlation between non-anticoagulated and anticoagulated samples. | N: 293 r: 0.99, Slope: 1.000, Intercept: 0.00 (See Table 13) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Precision (Aqueous Materials) - 20 Days: N=80-82 for iCa and Hct (number of measurements). Data provenance: Not specified, but likely internal lab data based on CLSI guidelines.
- Precision (Aqueous Materials) - Multi-site/Operator: N=90-97 for iCa and Hct (number of measurements). Data provenance: Three (3) sites, 2 operators per site. Not specified if within the US or international, or retrospective/prospective.
- Precision (Whole Blood): Sample sizes vary by analyte and range:
- iCa Venous: N=5-95
- iCa Arterial: N=0-92
- Hct Venous: N=7-88
- Hct Arterial: N=2-104
- Hct Capillary: N=17-109
- Data provenance: "collected across multiple point of care sites." Not specified if within the US or international, or retrospective/prospective, but implied prospective for the study as specimens were "collected with lithium heparin."
- Linearity/Assay Reportable Range: Sample not explicitly sized by patient count, but rather by varying analyte levels created from whole blood samples. Data provenance: Whole blood samples.
- Limit of Quantitation (LoQ): Whole blood samples (altered to low analyte level).
- Limit of Blank (LoB) & Detection (LoD): Whole blood samples (altered to blank/low levels).
- Analytical Specificity (Interference): Whole blood samples.
- Method Comparison:
- iCa Method Comparison: N=343 (pooled venous and arterial whole blood specimens).
- Hct Method Comparison (pooled): N=535 (venous, arterial, and capillary whole blood specimens).
- Hct Method Comparison (capillary only): N=208 (capillary whole blood specimens, native and contrived). N=193 for native only.
- Data provenance: "Lithium heparin venous and arterial whole blood specimens collected across multiple point of care sites." "Capillary whole blood specimens collected from skin puncture... across multiple point of care sites." Implied prospective collection for the study. Not specified if within the US or international.
- Matrix Equivalence: N=298 for iCa, N=293 for Hct. Data provenance: "non-anticoagulated venous and arterial whole blood specimens." Implied prospective collection for the study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is an in vitro diagnostic (IVD) instrument that provides quantitative measurements. The "ground truth" for these types of devices is established by a comparative method (often a laboratory reference method or another FDA-cleared device) rather than expert consensus on interpretations. The document explicitly mentions:
- iCa and Hct Method Comparison: The i-STAT CG8+ cartridge on the i-STAT 1 analyzer was compared against "a comparative method." For iCa, the predicate device i-STAT CHEM8+ was used as the comparative method. For Hct, the i-STAT CHEM8+ and Epoc Blood Analysis System were used as comparative methods.
- Traceability: iCa is traceable to NIST SRM956. Hct is traceable to CLSI H07-A3 procedure for determining packed cell volume by the microhematocrit method.
Therefore, no human experts were directly involved in establishing the ground truth for these quantitative measurements in terms of interpretation, as it's an analytical performance study against established analytical methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human readers interpret medical images or clinical findings and discrepancies need to be resolved. This study focuses on the analytical performance of a quantitative measurement device, where the ground truth is established by a "comparative method" or recognized reference standards, not by human interpretation requiring adjudication.
5. 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 is an analytical performance study for an IVD device, not a multi-reader multi-case clinical study involving human readers and AI assistance for interpretation. The device itself performs the measurement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this entire submission revolves around the standalone analytical performance of the i-STAT CG8+ cartridge with the i-STAT 1 System. The "algorithm" (the device's internal measurement and calculation processes) generates quantitative results without human interpretation as part of its core function, although trained medical professionals operate the device. All the precision, linearity, detection limit, interference, and method comparison studies are evaluations of this standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this quantitative measurement device is established through:
- Comparative Reference Methods: For method comparison studies, existing FDA-cleared or well-established laboratory methods (i-STAT CHEM8+ and Epoc Blood Analysis System) serve as the comparative ground truth.
- Certified Reference Materials/Standardized Procedures: Traceability to NIST SRM956 for iCa and CLSI H07-A3 for Hct indicates the use of recognized reference materials and standardized procedures for calibration and accuracy verification, which forms the basis for the ground truth in analytical measurements.
8. The sample size for the training set
The document does not explicitly describe a "training set" in the context of machine learning. This is an IVD device, and its development typically involves internal R&D, calibration, and verification rather than a dedicated machine learning "training set" as understood in AI/ML systems. All the presented studies are for validation of the finalized product.
9. How the ground truth for the training set was established
As there's no explicitly defined "training set" for a machine learning algorithm in the provided document, this question is not fully applicable. The development and internal validation of such a device generally rely on established metrological principles, using reference materials, spiked samples, and comparison to established methods to ensure accuracy and precision during its design and optimization phases.
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October 27, 2023
Abbott Point of Care, Inc. Brian Ma, Ph.D. Principal Specialist, Regulatory Affairs 400 College Road East Princeton, New Jersey 08540
Re: K230300
Trade/Device Name: i-STAT CG8+ cartridge with the i-STAT 1 System Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium Test System Regulatory Class: Class II Product Code: JFP, JPI Dated: September 28, 2023 Received: September 29, 2023
Dear Brian Ma:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Paula V. Caposino -S
Paula Caposino Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Ouality Center for Devices and Radiological HealthEnclosure
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
i-STAT CG8+ cartridge with the i-STAT 1 System
Indications for Use (Describe)
The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of ionized calcium and hematocrit in arterial or venous whole blood in point of care or clinical laboratory settings.
The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of hematocrit in capillary whole blood in point of care or clinical laboratory settings.
lonized calcium measurements are used in the diagnosis, monitoring, and treatment of conditions including, but not limited to, parathyroid disease, a variety of bone disease, chronic renal disease, tetany, and disturbances related to surgical and intensive care.
Hematocrit measurements can aid in the determination of normal or abnormal total red cell volume status that can be associated with conditions including anemia, erythrocytosis, and blood loss related to trauma and surgery.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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.
I. SUBMITTER INFORMATION
| Owner | Abbott Point of Care Inc.400 College Road EastPrinceton, NJ 08540 |
|---|---|
| Contact | Primary: Brian Ma, PhDPrincipal Specialist Regulatory AffairsPhone: +1613-688-5949 |
| Secondary: Mojgan SoleimaniAssociate Director Regulatory AffairsPhone: +1613-295-0932 | |
| Date Prepared | October 27, 2023 |
II. DEVICE INFORMATION
| Proprietary Name | i-STAT CG8+ cartridge with the i-STAT 1 System |
|---|---|
| Common Name | Chemistry test, hematology test, analyzer, handheld |
| 510(k) Number | K230300 |
| Product Code | Device ClassificationName | RegulationNumber | Class | Panel |
|---|---|---|---|---|
| JFP | Electrode, IonSpecific, Calcium | 862.1145 | II | Clinical Chemistry |
| JPI | Device, Hematocrit,Measuring | 864.6400 | II | Hematology |
III. PREDICATE DEVICE
| Proprietary Name | i-STAT CHEM8+ cartridge with the i-STAT 1 System |
|---|---|
| 510(k) Number | K191360 |
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| ProductCode | Device ClassificationName | RegulationNumber | Class | Panel |
|---|---|---|---|---|
| JFP | Electrode, Ion Specific,Calcium | 862.1145 | II | Clinical Chemistry |
IV. DEVICE DESCRIPTION
The i-STAT CG8+ cartridge is used with the i-STAT 1 analyzer as part of the i-STAT 1 System and contains test reagents to measure hematocrit (Hct) in arterial, venous or capillary whole blood and to measure ionized calcium (iCa) in arterial and venous whole blood.
The i-STAT 1 System is an in vitro diagnostic (IVD) medical device intended for the quantitative determination of various clinical chemistry tests contained within i-STAT cartridges using whole blood. The i-STAT 1 System consists of a portable blood analyzer (i-STAT 1 analyzer), single-use disposable test cartridges (i-STAT cartridges), liquid quality control and calibration verification materials, and accessories (i-STAT 1 Downloader/Recharger, i-STAT Electronic Simulator and i-STAT 1 Printer). The i-STAT 1 System, including the i-STAT CG8+ cartridge, is designed for use by trained medical professionals in point of care or clinical laboratory settings and is for prescription use only.
The i-STAT CG8+ cartridge contains the required sensors, a fluid pack (calibrant pouch), a sample entry well and closure, fluid channels, waste chamber, and the necessary mechanical features for controlled fluid movement within cartridge. The i-STAT cartridge format allows all the tests in the cartridge to be performed simultaneously. All the test steps and fluid movement occur within the i-STAT CG8+ cartridges require two to three drops of whole blood which are applied to the cartridge using a transfer device by the trained user before the cartridge is placed within the analyzer.
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 i-STAT CG8+ cartridge to move fluid across the sensors and generate a quantitative result (within approximately 2 minutes).
V. INTENDED USE STATEMENT
The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of ionized calcium and hematocrit in arterial or venous whole blood in point of care or clinical laboratory settings.
The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of hematocrit in capillary whole blood in point of care or clinical laboratory settings.
Ionized calcium measurements are used in the diagnosis, monitoring, and treatment of conditions including, but not limited to, parathyroid disease, a variety of bone diseases, chronic renal disease, tetany, and disturbances related to surgical and intensive care.
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, erythrocytosis, and blood loss related to trauma and surgery.
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VI. SUMMARY COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| Table 1: Similarities and Differences (Test and Instrument): iCa and Hct in Whole Blood | ||
|---|---|---|
| Feature orCharacteristic | Candidate Devices:iCa and Hct Tests in the:i-STAT CG8+ cartridgewith the i-STAT 1 System | Predicate Device:iCa Test in the:i-STAT CHEM8+ cartridgewith the i-STAT 1 System(K191360) |
| Intended Use | The i-STAT CG8+ cartridge with thei-STAT 1 System is intended for use in thein vitro quantification of ionized calciumand hematocrit in arterial or venouswhole blood in point of care or clinicallaboratory settings.The i-STAT CG8+ cartridge with the i-STAT1 System is intended for use in the in vitroquantification of hematocrit in capillarywhole blood in point of care or clinicallaboratory settings.Ionized calcium measurements are usedin the diagnosis, monitoring, andtreatment of conditions including, but notlimited to, parathyroid disease, a varietyof bone diseases, chronic renal disease,tetany, and disturbances related tosurgical and intensive care.Hematocrit measurements can aid in thedetermination and monitoring of normalor abnormal total red cell volume statusthat can be associated with conditionsincluding anemia, erythrocytosis, andblood loss related to trauma and surgery. | The i-STAT CHEM8+ cartridge with the i-STAT 1 System is intended for use in the invitro quantification of ionized calcium inarterial or venous whole blood in point ofcare or clinical laboratory settings.Ionized calcium measurements are usedin the diagnosis and treatment ofparathyroid disease, a variety of bonediseases, chronic renal disease andtetany. |
| DeviceClassification | Same | Class II |
| Product Code | JFP (iCa)JPI (Hct) | JFP (iCa) |
| RegulationNo. | 862.1145 (iCa)864.6400 (Hct) | 862.1145 (iCa) |
| ReportableRange | Same | iCa 0.25 – 2.50 mmol/L1.0 – 10.0 mg/dLHct 15 – 75 %PCV0.15 – 0.75 Fraction |
| Table 1: Similarities and Differences (Test and Instrument): iCa and Hct in Whole Blood | ||
| Feature or Characteristic | Candidate Devices:iCa and Hct Tests in the:i-STAT CG8+ cartridgewith the i-STAT 1 System | Predicate Device:iCa Test in the:i-STAT CHEM8+ cartridgewith the i-STAT 1 System(K191360) |
| Sample Type | iCa Arterial or venous whole bloodHct Arterial, venous, or capillary whole blood | Arterial and venous whole blood |
| Sample Volume | Same | 95 µL |
| Sample Preparation | Same | Ready to Use |
| Sample collection | Without anticoagulant Arterial or venous | With balanced heparin anticoagulant or lithium heparin anticoagulant |
| With balanced heparin anticoagulant or lithium heparin anticoagulant | ||
| iCa Arterial or venousHct Arterial, venous, or capillary | ||
| Traceability | Same | iCa NIST SRM956Hct CLSI H07-A3 procedure for determining packed cell volume by the microhematocrit method |
| Calibration | Same | 1-point on-board contained within cartridge |
| Principle of Measurement | iCa: Ion-selective electrode potentiometryHct: Conductometric method | iCa: Ion-selective electrode potentiometry |
| Reagent Format | Same | Cartridge |
| Reagent Storage and Stability | Refrigerated at 2-8°C (35-46°F) until expiration dateRoom Temperature at 18-30°C (64-86°F) for 2 months | Refrigerated at 2-8°C (35-46°F) until expiration dateRoom Temperature at 18-30°C (64-86°F) for 14 days |
| Analyzer Type | Same | Handheld |
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VII. PERFORMANCE CHARACTERISTICS
A. Analytical Performance
a. Precision/Reproducibility:
i. Precision 20 days (Aqueous materials)
The precision of the i-STAT Ionized Calcium (iCa) test in the i-STAT CG8+ cartridge on the i-STAT 1 System was evaluated using five (5) levels of aqueous material. The precision of the i-STAT Hematocrit (Hct) test in the i-STAT CG8+ cartridge on the i-STAT 1 System was evaluated using four (4) levels of aqueous materials. This 20-day precision testing was based on CLSI document EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition. Each study was conducted using multiple analyzers and one (1) test cartridge lot over at least 20 days at one site. Repeatability, betweenrun, between-day, and within-laboratory precision were estimated for each level. The results of the 20-day precision study for the i-STAT CG8+ cartridge on the i-STAT 1 System are shown in Table 2.
| Table 2: Results of 20-Day Precision of the i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Test(units) | FluidLevel | N | Mean | Repeatability | Between-run | Between-day | Within-Laboratory | ||||
| SD | %CV | SD | %CV | SD | %CV | SD | %CV | ||||
| iCa(mmol/L) | CV L1 | 80 | 2.280 | 0.0129 | 0.57 | 0.0050 | 0.22 | 0.0036 | 0.16 | 0.0144 | 0.63 |
| CV L2 | 80 | 1.517 | 0.0073 | 0.48 | 0.0023 | 0.15 | 0.0020 | 0.13 | 0.0080 | 0.52 | |
| CV L3 | 80 | 1.282 | 0.0080 | 0.63 | 0.0020 | 0.15 | 0.0018 | 0.14 | 0.0085 | 0.66 | |
| CV L4 | 80 | 0.763 | 0.0034 | 0.44 | 0.0018 | 0.23 | 0.0010 | 0.13 | 0.0039 | 0.51 | |
| CV L5 | 80 | 0.260 | 0.0018 | 0.68 | 0.0007 | 0.27 | 0.0006 | 0.22 | 0.0020 | 0.76 | |
| Hct(%PCV) | CV L2 | 81 | 22.0 | 0.38 | 1.74 | 0.12 | 0.54 | 0.11 | 0.48 | 0.42 | 1.89 |
| CV L3 | 80 | 35.0 | 0.41 | 1.17 | 0.14 | 0.40 | 0.11 | 0.32 | 0.45 | 1.27 | |
| CV L4 | 80 | 56.4 | 0.22 | 0.40 | 0.12 | 0.21 | 0.10 | 0.18 | 0.27 | 0.48 | |
| CV L5 | 82 | 66.3 | 0.24 | 0.35 | 0.02 | 0.03 | 0.06 | 0.09 | 0.24 | 0.37 |
ii. Multi-site and operator-to-operator precision (Aqueous materials)
Multi-day precision testing was performed at three (3) sites using a panel of aqueous solutions containing five (5) levels of ionized calcium and a second panel of aqueous solutions containing five (5) levels of hematocrit. At each site, each level was tested once a day by two (2) operators for five (5) days on six (6) i-STAT 1 Analyzers using i-STAT CG8+ cartridges. Within-run, between-day, betweenoperator and within-site (total) variance components were calculated by site. These components were also calculated for all sites combined and provided in the Table 3 below.
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| Table 3: Multi-Day Precision of the i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Test(units) | FluidLevel | N | Mean | Within-Run | Between-Day | Between-Operator | Within-Site (Total) | Between-Site | Overall | ||||||
| SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | ||||
| iCa(mmol/L) | CV L1 | 91 | 2.323 | 0.0147 | 0.63 | 0.0104 | 0.45 | 0.0000 | 0.00 | 0.018 | 0.77 | 0.0079 | 0.34 | 0.0196 | 0.84 |
| CV L2 | 90 | 1.535 | 0.0078 | 0.51 | 0.0043 | 0.28 | 0.0000 | 0.00 | 0.0089 | 0.58 | 0.0018 | 0.12 | 0.0091 | 0.59 | |
| CV L3 | 97 | 1.288 | 0.0068 | 0.53 | 0.0000 | 0.00 | 0.0013 | 0.10 | 0.0069 | 0.53 | 0.0000 | 0.00 | 0.0069 | 0.53 | |
| CV L4 | 90 | 0.762 | 0.0049 | 0.64 | 0.0000 | 0.00 | 0.0000 | 0.00 | 0.0049 | 0.64 | 0.0008 | 0.10 | 0.0049 | 0.65 | |
| CV L5 | 90 | 0.260 | 0.0011 | 0.41 | 0.0000 | 0.00 | 0.0000 | 0.00 | 0.0011 | 0.41 | 0.0000 | 0.00 | 0.0011 | 0.41 | |
| Hct(%PCV) | CV L1 | 90 | 12.2 | 0.34 | 2.75 | 0.18 | 1.45 | 0.11 | 0.89 | 0.39 | 3.24 | 0.12 | 0.97 | 0.41 | 3.38 |
| CV L2 | 90 | 22.1 | 0.35 | 1.57 | 0.00 | 0.00 | 0.13 | 0.57 | 0.37 | 1.67 | 0.20 | 0.92 | 0.42 | 1.90 | |
| CV L3 | 90 | 35.1 | 0.36 | 1.03 | 0.00 | 0.00 | 0.08 | 0.22 | 0.37 | 1.06 | 0.11 | 0.31 | 0.39 | 1.10 | |
| CV L4 | 90 | 56.3 | 0.45 | 0.80 | 0.09 | 0.16 | 0.00 | 0.00 | 0.46 | 0.81 | 0.27 | 0.48 | 0.53 | 0.95 | |
| CV L5 | 90 | 66.1 | 0.31 | 0.47 | 0.17 | 0.26 | 0.06 | 0.10 | 0.36 | 0.54 | 0.14 | 0.21 | 0.38 | 0.58 |
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iii. Precision (Whole Blood)
Whole blood precision of the i-STAT Ionized Calcium and Hematocrit tests in the i-STAT CG8+ cartridge on the i-STAT 1 System was evaluated using whole blood specimens 1 collected with lithium heparin. The whole blood precision was assessed using the duplicate test results collected across multiple point of care sites. The mean values for each sample were divided into subintervals for each sample type across the reportable range for each i-STAT test. The results are summarized in Table 4.
| cartridge on the i-STAT 1 Analyzer | ||||||
|---|---|---|---|---|---|---|
| Test(units) | Sample Type | Sample Range | N | Mean | SD | %CV |
| iCa(mmol/L) | Venous Whole Blood | 0.25-0.75 | 5 | 0.468 | 0.0045 | 0.96 |
| >0.75-1.20 | 95 | 1.123 | 0.0094 | 0.84 | ||
| >1.20-1.50 | 77 | 1.281 | 0.0165 | 1.29 | ||
| >1.50-2.50 | 7 | 2.179 | 0.0214 | 0.98 | ||
| Arterial Whole Blood | 0.25-0.75 | 0 | N/A | N/A | N/A | |
| >0.75-1.20 | 92 | 1.144 | 0.0063 | 0.55 | ||
| >1.20-1.50 | 58 | 1.282 | 0.0114 | 0.89 | ||
| >1.50-2.50 | 3 | 1.797 | 0.0100 | 0.56 | ||
| Hct(%PCV) | Venous Whole Blood | 15-35 | 88 | 27.3 | 0.45 | 1.63 |
| >35-50 | 75 | 39.4 | 2.20 | 5.59 | ||
| >50-75 | 7 | 60.1 | 0.46 | 0.77 | ||
| Arterial Whole Blood | 15-35 | 104 | 26.3 | 0.55 | 2.08 | |
| >35-50 | 45 | 38.9 | 0.48 | 1.24 | ||
| >50-75 | 2 | 50.0 | 0.00 | 0.00 | ||
| Capillary Whole Blood | 15-35 | 28 | 29.5 | 1.23 | 4.18 | |
| >35-50 | 109 | 41.1 | 1.10 | 2.68 | ||
| >50-75 | 17 | 53.5 | 0.95 | 1.78 |
Table 4: Whole Blood Precision of arterial, venous, and capillary whole blood for i-STAT CG8+
b. Linearity/assay reportable range:
i. Linearity
The study was designed based on CLSI EP06-Ed2: Evaluation of the Linearity of Quantitative Measurement Procedures - Second Edition.
The linearity of the i-STAT Ionized Calcium and Hematocrit tests in the i-STAT CG8+ cartridge with the i-STAT 1 System was evaluated by preparing whole blood samples of varying analyte levels for each i-STAT test. The i-STAT Ionized Calcium and Hematocrit tests in the i-STAT CG8+ cartridge demonstrated linearity over the reportable range for each i-STAT test. Regression summary of the response for each i-STAT test versus the concentration of the whole blood samples of varying analyte levels is provided in Table 5.
| Table 5: Regression Summary for the i-STAT iCa and Hct tests in the i-STAT CG8+ Cartridge on | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| the i-STAT 1 Analyzer | ||||||||||
| Test | Units | Reportable Range | Range Tested | Slope | Intercept | R | ||||
| iCa | mmol/L | 0.25 - 2.50 | 0.204 - 2.832 | 1.016 | 0.019 | 0.9981 |
1 The capillary whole blood clinical precision study design included the performance of two individual fingersticks, collected independently by two operators into two separate capillary tubes and tested on two (2) i-STAT CG8+ cartridges.
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| Table 5: Regression Summary for the i-STAT iCa and Hct tests in the i-STAT CG8+ Cartridge onthe i-STAT 1 Analyzer | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Test | Units | Reportable Range | Range Tested | Slope | Intercept | R | ||||
| Hct | %PCV | 15 — 75 | 12.7 - 78.3 | 1.031 | -0.592 | 0.9992 |
c. Detection Limit
Limit of Quantitation (LoQ) i.
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 Ionized Calcium and Hematocrit tests in the i-STAT CG8+ cartridge was evaluated on the i-STAT 1 analyzer using two (2) i-STAT CG8+ cartridge lots, and whole blood that was altered to a low analyte level for each i-STAT test. The LoQ for the i-STAT Ionized Calcium and Hematocrit tests in the i-STAT CG8+ cartridge was determined to be at or below the lower limit of the reportable range for each of the i-STAT tests as shown in Table 6.
| Table 6: Summary of LoQ Results for i-STAT Tests in the i-STAT CG8+ Cartridge | ||
|---|---|---|
| Test (units) | Lower limit of the reportable range | Determined LoQ |
| iCa (mmol/L) | 0.25 | 0.15 |
| Hct (%PCV) | 15 | 13 |
ii. 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 and LoD of the i-STAT Ionized Calcium (iCa) and Hematocrit (Hct) tests in the i-STAT CG8+ cartridge were evaluated on the i-STAT 1 analyzer using two (2) i-STAT CG8+ cartridge lots for each test. Whole blood was altered to blank ionized calcium and hematocrit levels for LoB testing. Whole blood was altered to two (2) low levels of ionized calcium and four (4) low levels of hematocrit for LoD testing.
The LoB and LoD were determined based on the maximal LoB or LoD value obtained for each lot tested.
The determined LoB and LoD for i-STAT Ionized Calcium and Hematocrit tests in the i-STAT CG8+ cartridge on the i-STAT 1 analyzer are shown in the Table 7.
| Table 7: Summary of LoB and LoD Results | ||
|---|---|---|
| Test(units) | i-STAT CG8+ CartridgeLoB | i-STAT CG8+ CartridgeLoD |
| iCa (mmol/L) | 0.119 | 0.125 |
| Hct (%PCV) | 0 | 0.4 |
d. Analytical Specificity
i. Interference
The study was based on CLSI EP07-ED3: Interference Testing in Clinical Chemistry, Third Edition.
The interference performance of the i-STAT Ionized Calcium and Hematocrit tests in the i-STAT CG8+ cartridge on the i-STAT 1 analyzer with the i-STAT 1 System
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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 test 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 allowable error (±Ea) for the i-STAT test. For an identified interferent, a dose-response was performed to determine the degree of interference as a function of the substance concentration.
Table 8 contains the list of potentially interfering substances tested and the interference results for the i-STAT CG8+ cartridge.
| i-STAT CG8+ Cartridge | |||||
|---|---|---|---|---|---|
| Substance 2 | mmol/L(unless specified) | mg/dL(unless specified) | i-STAT Test | Interference(Yes/No) | Comments |
| Acetaminophen | 1.03 | 15.6 | iCa | No | |
| Acetyl Cysteine(N-Acetyl-L-Cysteine) | 0.92 | 15 | iCa | No | |
| Ascorbic Acid(L-Ascorbic Acid) | 0.298 | 5.25 | iCa | No | |
| β-Hydroxybutyric Acid3 | 6.0 | 62.46 | iCa | No | |
| Bilirubin | 0.684 | 40 | iCaHct | NoNo | |
| Bromide 3(Lithium Bromide) | 2.537.5 | 21.7325.7 | iCaHct | NoYes | |
| iCaHct | YesYes | Use Another Method | |||
| Cholesterol | 11.0 | 425 | iCa | No | |
| Hemoglobin | 10 g/L | 1000 | iCa | No | |
| N/A | 3447 | iCa | No | ||
| Intralipid 20% | 2325 | Hct | No | ||
| Iodide (Sodium Iodide)3 | 2.99 | 44.82 | iCa | No | |
| Lactate(Lithium Lactate) | 10 | 90 | iCa | Yes | Decreased results ≥ 6 mmol/L |
| Leflunomide | 0.722 | 19.5 | iCa | Yes | Decreased results ≥ 0.345 mmol/L |
| Magnesium(Magnesium Chloride) | 4.1 | 10 | iCa | Yes | Increased results ≥ 3.5 mmol/L |
| Nithiodote(Sodium Thiosulfate)3 | 16.7 | 264.04 | HctiCa | NoYes | |
| Decreased results ≥ 5.3 mmol/L | |||||
| Potassium (PotassiumChloride) | 8 | 59.6 | iCa | No | |
| Salicylate(Lithium Salicylate) | 0.207 | 2.86 | iCa | No | |
| Sodium(Sodium Chloride) | 170 | 993.48 | iCa | No | |
| Table 8: Potentially Interfering Substances and Test Concentrations for the i-STAT tests in the | |||||
| i-STAT CG8+ Cartridge | |||||
| Substance 2 | Test Concentration | ||||
| mmol/L(unlessspecified) | mg/dL(unlessspecified) | i-STATTest | Interference(Yes/No) | Comments | |
| Teriflunomide 3 | 0.722 | 19.5 | iCa | Yes | Decreased results≥ 0.049 mmol/L |
| Thiocyanate (LithiumThiocyanate) | 0.898 | 5.22 | iCa | Yes | Decreased results≥ 0.898 mmol/L |
| Total Protein (HumanSerum Albumin) | 15 g/dL | 150 g/L | Hct | Yes | Increased results ≥9.5 g/dL |
| Triglyceride | 16.94 | 1500 | iCaHct | No | |
| White Blood Cells | 50,000WBC/μL | N/A | Hct | No |
Table 8: Potentially Interfering Substances and Test Concentrations for the i-STAT tests in the
2 The test concentration for this substance is not included in CLSI guideline EP37 1st edition.
23 The compound tested to evaluate the interfering substance is presented in parenthesis.
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B. Comparison Studies
a. Method Comparison with Comparator Device
Method comparison for the i-STAT CG8+ cartridge with the i-STAT 1 System was demonstrated in studies based on CLSI EP09c-ED3: Measurement Procedure Comparison and Bias Estimation Using Patient Samples – Third Edition.
Lithium heparin venous and arterial whole blood specimens collected across multiple point of care sites were evaluated using i-STAT CG8+ cartridges on the i-STAT 1 analyzer against whole blood specimens tested on a comparative method. For ionized calcium and hematocrit, the first replicate result from the i-STAT 1 analyzer was compared to the mean result from the comparative method.
Two (2) capillary whole blood specimens collected from skin puncture with balanced heparin capillary tubes from each study subject across multiple point of care sites were evaluated and analyzed in singlicate on the i-STAT 1 analyzer against the comparative method. A Passing-Bablok linear regression analysis for hematocrit was performed using the singlicate result from the i-STAT 1 analyzer versus the singlicate result of the comparative method.
The venous and arterial data were pooled, and a Passing-Bablok linear regression analysis was performed using the i-STAT Ionized Calcium results from the i-STAT CG8+ cartridges on the i-STAT 1 analyzer versus the comparative method results. Method comparison results comparing the i-STAT Ionized Calcium performance on the i-STAT 1 analyzer to comparative method for arterial and venous are shown in Table 9. In the table, N is the number of specimens in the data set, and r is the correlation coefficient.
| Table 9: Method Comparison Results for the i-STAT iCa test in the i-STAT CG8+ Cartridge withi-STAT 1 System | |||||||
|---|---|---|---|---|---|---|---|
| Test(units) | ComparativeMethodArterial/Venous | N | Slope | Intercept | r | MedicalDecisionLevel | Bias at MedicalDecision Level |
| iCa(mmol/L) | i-STAT CHEM8+ | 343 | 1.02 | -0.02 | 0.99 | 0.370.82 | -0.0090.003 |
The venous, arterial, and capillary whole blood data were pooled, and a Passing-Bablok linear regression analysis was performed using the i-STAT Hematocrit results from the i-STAT CG8+ cartridges on the i-STAT 1 analyzer versus the comparative method results.
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Method comparison results comparing the i-STAT Hematocrit performance on the i-STAT 1 analyzer to the comparative method for arterial venous, and capillary whole blood specimens are shown in Table 10. In the table, N is the number of specimens in the data set, and r is the correlation coefficient.
| Table 10: Method Comparison Results for the i-STAT Hct test in the i-STAT CG8+ Cartridge withi-STAT 1 System | ||||||||
|---|---|---|---|---|---|---|---|---|
| Test(units) | ComparativeMethod | N | Slope | Intercept | r | MedicalDecisionLevel | Bias at MedicalDecision Level | |
| Arterial/Venous | Capillary | |||||||
| Hct(%PCV) | i-STATCHEM8+ | EpocBloodAnalysisSystem | 535 | 1.000 | -1.00 | 0.98 | 33 | -1.0 |
| Blood | 53 | -1.0 | ||||||
| Analysis | 56 | -1.0 | ||||||
| System | 70 | -1.0 |
The method comparison results for capillary whole blood specimens only for the i-STAT Hematocrit test are shown in Table 11.
| Table 11: Results for i-STAT CG8+ Cartridge with i-STAT 1 System - Native and Contrived Capillary Specimens | |||||
|---|---|---|---|---|---|
| Test(units) | N | Slope | Intercept | r | Range |
| Hct(%PCV) | 208 | 1.000 | 0.00 | 0.97 | 18-73 |
Bias at the medical decision levels for native capillary whole blood specimens only for the i-STAT Hematocrit test are shown in Table 12.
| Table 12: Results for i-STAT CG8+ Cartridge with i-STAT 1 System - Native Capillary Specimens | |||||||
|---|---|---|---|---|---|---|---|
| Bias at Medical Decision Levels | |||||||
| Test(units) | N | RangeMin | RangeMax | MedicalDecision Level | Bias | ||
| Estimate | 95% CI | ||||||
| Hct(%PCV) | 193 | 23 | 68 | 33 | 0.0 | (-1.0, 0.0) | |
| 53 | 0.0 | (-1.0, 0.0) | |||||
| 56 | 0.0 | (-1.0, 0.0) | |||||
| 70 | 0.0 | (-1.0, 0.0) |
b. Matrix Equivalence
A matrix equivalence study was conducted to evaluate the performance of the i-STAT Ionized Calcium and Hematocrit tests in the i-STAT CG8+ cartridge on the i-STAT 1 System using non-anticoagulated venous and arterial whole blood specimens. The study design and analysis method were based on recommendations from the Clinical and Laboratory Standards Institute (CLSI) guideline EP35: Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures, 1st ed. The matrix equivalence of each test in the i-STAT CG8+ cartridge was assessed by comparing arterial or venous whole blood specimens collected without
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anticoagulant (candidate specimen type) to samples collected with balanced heparin or lithium heparin anticoagulant (primary specimen type). Each specimen was tested in duplicate using two (2) i-STAT CG8+ cartridges with two (2) i-STAT 1 analyzers. A Passing-Bablok linear regression analysis was performed using the first replicate result from the candidate (y-axis) versus the mean result from the primary specimen (x-axis). The regression analysis results are summarized in Table 13. In the table, N is the number of specimens in the data set, and r is the correlation coefficient.
| Table 13: Matrix Equivalence Results | |||||||
|---|---|---|---|---|---|---|---|
| Test (units) | N | CandidateSpecimen Range | Primary SpecimenRange | r | Slope | Intercept | |
| iCa (mmol/L) | 298 | 0.44-2.43 | 0.45-2.42 | 0.99 | 1.00 | 0.01 | |
| Hct (%PCV) | 293 | 15-73 | 15-73 | 0.99 | 1.000 | 0.00 |
CONCLUSION
VIII.
The results of these studies demonstrate that performance of the i-STAT Ionized Calcium and Hematocrit tests in the i-STAT CG8+ cartridge with the i-STAT 1 System are substantially equivalent to the predicate device.
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.