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510(k) Data Aggregation

    K Number
    K163271
    Device Name
    i-Stat Alinity System with i-Stat Glucose test
    Manufacturer
    Abbott Point of Care, Inc.
    Date Cleared
    2017-04-10

    (140 days)

    Product Code
    CGA
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K103195
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The i-STAT Alinity System with i-STAT Glucose test is intended for use or clinical laboratory settings. The i-STAT Alinity System with Glucose test is intended for the quantitative measurement of glucose in arterial and venous whole blood.

    Glucose measurements are used in the diagnosis, monitoring, and treatment of carbohydrate metabolism disorders including, but not limited to, diabetes mellitus, idiopathic hypoglycemia, and pancreatic islet cell carcinoma. The i-STAT Glucose test with the i-STAT Alinity System has not been evaluated in neonates.

    For in vitro diagnostic use.

    Device Description

    The i-STAT System is a handheld, in vitro diagnostic analytical device designed to run only i-STAT test cartridges. 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 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 test reagents which are located on the sensors. 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.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study used to prove the device meets them, based on the provided text:

    Device: i-STAT Alinity System with i-STAT Glucose test

    Intended Use: Quantitative measurement of glucose in arterial and venous whole blood for diagnosis, monitoring, and treatment of carbohydrate metabolism disorders.

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly present a table of "acceptance criteria" vs. "reported performance" in a single, consolidated table with specific pass/fail thresholds. Instead, it details various performance characteristics and their observed results, implying that meeting these results demonstrates acceptable performance. I will construct a table reflecting this, drawing from the "Performance Characteristics" section.

    Performance CharacteristicAcceptance Criteria (Implied)Reported Device Performance and Results
    Precision (Aqueous)Demonstrate acceptable within-laboratory, within-run, between-run, and between-day precision across 5 glucose levels.CV L1 (26.9 mg/dL): ST: 0.42 (1.56%CV), Sr: 0.22 (0.82%CV), Srr: 0.34 (1.26%CV), Sdd: 0.12 (0.45%CV)CV L2 (41.0 mg/dL): ST: 0.34 (0.83%CV), Sr: 0.20 (0.49%CV), Srr: 0.18 (0.44%CV), Sdd: 0.21 (0.51%CV)CV L3 (125.0 mg/dL): ST: 0.32 (0.26%CV), Sr: 0.21 (0.17%CV), Srr: 0.23 (0.18%CV), Sdd: 0.09 (0.07%CV)CV L4 (286.7 mg/dL): ST: 0.77 (0.27%CV), Sr: 0.53 (0.18%CV), Srr: 0.52 (0.18%CV), Sdd: 0.22 (0.08%CV)CV L5 (600.6 mg/dL): ST: 3.47 (0.58%CV), Sr: 2.42 (0.40%CV), Srr: 2.26 (0.38%CV), Sdd: 1.06 (0.18%CV)All results fall within typical expectations for precision in diagnostic devices.
    Precision (Whole Blood)Demonstrate acceptable within-instrument and total precision across 6 glucose levels.Concentration (mg/dL) / Total SD / Total %CV:30-50: 0.36-0.51 / 0.97-1.16%51-110: 0.22-0.51 / 0.21-0.61%111-150: 0.48-0.64 / 0.38-0.54%151-250: 0.54-0.70 / 0.22-0.38%251-400: 1.43-2.53 / 0.41-0.73%401-700: 2.81-7.46 / 0.49-1.36%All results fall within typical expectations for precision in diagnostic devices, with CVs generally below 2%.
    LinearityDemonstrate linearity across the reportable range (20-700 mg/dL).Best fitting regression model was a second-order model. Absolute value of non-linearity ranged from 0.00 to 23.8 mg/dL. Demonstrated linearity over the reportable range (20-700 mg/dL).
    RecoveryDemonstrate acceptable recovery bias and % recovery across the reportable range (20-700 mg/dL).% recovery ranged from 94.6% to 100.3% across the glucose reportable range (20-700 mg/dL).
    Limit of Quantitation (LoQ)Establish the LoQ.LoQ determined to be 5.558 mg/dL.
    InterferenceIdentify compounds that do and do not interfere with glucose measurements (difference > 10% from control).Non-interfering compounds (at specified concentrations): Acetaminophen, Acetaldehyde, Acetoacetate, L-Ascorbic Acid, Acetyl Cysteine, Ammonium Chloride, Bromide, β-Hydroxybutyric Acid, Dopamine, Ethanol, Fluoride, Formaldehyde, Glycolic Acid, Gentamicin, Glucosamine, Glutathione, Guaifenesin, Hemoglobin, Heparin, Ibuprofen, Isoniazid, Lactate, Mannose, Maltose, pH, Pyruvate, Salicylate, Thiocyanate, Triglyceride, Uric Acid, Sodium Thiosulfate, Bilirubin, Cholesterol, Creatinine, Fructose, Galactose, Xylose.Interfering compound (at specified concentrations): Hydroxyurea concentration above 0.43 mmol/L may falsely elevate i-STAT glucose by >10%.
    Anticoagulant StudyDemonstrate equivalence between heparinized and non-anticoagulated whole blood.Deming regression result: slope of 1.00 and correlation coefficient of 1.00.
    Altitude StudyDemonstrate equivalent performance at altitudes up to 10,000 feet compared to sea level.Performance at altitude up to 10,000 feet was found to be equivalent to performance at sea level.
    Oxygen StudyDemonstrate equivalent glucose results at low and high oxygen levels.This study demonstrated equivalent glucose results when evaluated at low and high oxygen levels for all glucose concentrations tested.
    Method Comparison with Predicate DeviceDemonstrate substantial equivalence to the predicate device (i-STAT 1 Wireless Analyzer).Weighted Deming regression for all 3 sites combined: slope of 0.999, intercept of 1.164, and correlation coefficient of 1.000. These results demonstrate substantial equivalence.

    2. Sample sizes used for the test set and the data provenance

    This section generally refers to the performance studies.

    • Precision (Aqueous):
      • Sample Size: 80 measurements per level for 5 levels (Total N = 400 test results).
      • Data Provenance: Not explicitly stated, but typically performed in a controlled laboratory setting (likely within the US, given the FDA submission). Retrospective/Prospective not specified, but usually prospective for such evaluations.
    • Precision (Whole Blood):
      • Sample Size: 21 test results per sample (3 tests x 7 instruments) for each of 6 concentration levels, across 3 sites. The total number of unique patient samples is not explicitly stated (the text mentions "venous whole blood (native or altered) samples targeted to six different glucose levels"). If each target level had a unique set of samples across sites, it would be at least 18 distinct sample pools (6 levels x 3 sites), each with 21 replicates.
      • Data Provenance: Performed at 3 point-of-care sites. Likely prospective, collecting fresh whole blood samples. Country of origin not specified, but likely US.
    • Linearity:
      • Sample Size: Not explicitly stated as a number of patient samples. It evaluated a "series of glucose concentration levels in whole blood."
      • Data Provenance: Not specified.
    • Recovery:
      • Sample Size: A "series of glucose concentration levels in whole blood." Not a specific count.
      • Data Provenance: Not specified.
    • Limit of Quantitation (LoQ):
      • Sample Size: Not explicitly stated, involved "whole blood that was altered to low glucose concentrations (< 20 mg/dL)."
      • Data Provenance: Not specified.
    • Interference:
      • Sample Size: Evaluated "whole blood test samples based on CLSI EP07-A2." Not a specific count of unique samples, but rather a set of samples spiked with various compounds.
      • Data Provenance: Not specified.
    • Anticoagulant Study:
      • Sample Size: 40 blood samples.
      • Data Provenance: Not specified.
    • Altitude Study:
      • Sample Size: Not a count of patient samples, but evaluated against "commercially available i-STAT Glucose control materials that represented 3 Glucose levels."
      • Data Provenance: Not specified, likely laboratory simulation.
    • Oxygen Study:
      • Sample Size: "whole blood samples... at four glucose levels." Not a specific count.
      • Data Provenance: Not specified, likely laboratory simulation.
    • Method Comparison with Predicate Device:
      • Sample Size: 237 subjects.
      • Data Provenance: Conducted across 3 point-of-care sites. Likely prospective collection of fresh venous or arterial whole blood samples. Country of origin not specified, but again, likely US.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    Not applicable. This device is an in vitro diagnostic (IVD) device for quantitative measurement of glucose. The "ground truth" or reference values are established by laboratory methods, typically using a validated reference method (like hexokinase method on a central lab analyzer) or traceable reference materials, not expert human interpretation. The clinical method comparison is against a legally marketed predicate device, not against expert consensus.

    4. Adjudication method for the test set

    Not applicable. This device provides a quantitative measurement of a biomarker. "Adjudication" typically refers to resolving discrepancies in human interpretation or classification, which isn't the primary mechanism for establishing ground truth for a glucose measurement device. The "ground truth" for the device's accuracy would be established by comparison to a traceable reference method.

    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 in vitro diagnostic device for quantitative chemical measurement, not an AI-assisted diagnostic imaging or interpretation device that would involve human "readers" or "AI assistance."

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    Yes. All performance characteristics listed (Precision, Linearity, Recovery, LoQ, Interference, Anticoagulant, Altitude, Oxygen studies) represent the standalone performance of the i-STAT Alinity System with the i-STAT Glucose test. The "Method Comparison with Predicate Device" also evaluates the standalone performance of the new device against another standalone device. There is no AI component or human-in-the-loop aspect described for the glucose measurement itself; the device provides a direct quantitative result.

    7. The type of ground truth used

    The type of ground truth used for the analytical performance studies (Precision, Linearity, Recovery, LoQ, Interference) would typically be:

    • For Precision (Aqueous) and Linearity: Certified reference materials (e.g., NIST SRM965 is mentioned for test traceability) or highly characterized control materials with assigned values. For linearity, serially diluted or spiked samples measured against a reference method.
    • For Precision (Whole Blood) and Method Comparison: Typically, a validated and highly accurate laboratory reference method for glucose measurement (e.g., spectrophotometric hexokinase method) performed on a central laboratory analyzer would serve as the "ground truth" or comparator for blood samples. The document states a comparison to the predicate device (i-STAT 1 Wireless Analyzer) for method comparison, which itself would have been validated against such a reference.
    • For Recovery, LoQ, Interference, Anticoagulant, Altitude, Oxygen Studies: These studies involve specific sample preparations (e.g., spiked samples, altered concentrations, different oxygen levels) and the "ground truth" would be either the known prepared concentration or the measurement by a trusted reference method.

    8. The sample size for the training set

    Not applicable. This is a traditional in vitro diagnostic device, not an AI/Machine Learning device that requires a "training set." Its operation is based on established electrochemical principles, not on learning from data.

    9. How the ground truth for the training set was established

    Not applicable, as there is no training set for this type of device.

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