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K Number
K183680
Device Name
i-STAT CHEM8+ cartridge with the i-STAT 1 System
Manufacturer
Abbott Point of Care Inc.
Date Cleared
2020-02-28

(427 days)

Product Code
JPI
Regulation Number
864.6400
Type
Traditional
Panel
HE
Reference & Predicate Devices
k163342
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The i-STAT CHEM8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of hematocrit in arterial or venous whole blood in point of care or clinical laboratory settings. Hematocrit measurements can aid in the determination and monitoring of normal total red cell volume status that can be associated with conditions including anemia and erythrocytosis. The i-STAT Hematocrit test has not been evaluated in neonates.

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.

AI/ML Overview

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:

  1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Performance Metric)Acceptance CriteriaReported 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) - VenousNot explicitly stated as acceptance criteria, but study results presented for various ranges.≤ 35%PCV: 1.6% CV
    Precision (Whole Blood) - ArterialNot explicitly stated as acceptance criteria, but study results presented for various ranges.≤ 35%PCV: 7.1% CV
    LinearityAbsolute 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
    Interference95% 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

  2. 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).

  3. 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.

  4. 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.

  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 device is an in-vitro diagnostic (IVD) instrument for quantitative measurement of hematocrit, not an AI imaging or diagnostic algorithm that assists human readers.

  6. 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.

  7. 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.

  8. 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.

  9. How the Ground Truth for the Training Set Was Established

    • Not applicable, as no training set (for machine learning) is relevant to this device.

§ 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.