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The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of glucose in arterial, venous, or capillary whole blood in point of care or clinical laboratory settings.

Glucose measurements are used in the diagnosis, monitoring, and treatment of carbohydrate metabolism disorders including, but not limited to, diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma.

The i-STAT 1 Analyzer is intended for use in the in vitro quantification of various analytes in whole blood or plasma in point of care or clinical laboratory settings. Analyzers and cartridges should be used by healthcare professionals trained and certified to use the system and should be used according to the facility's policies and procedures.

The i-STAT System is for in vitro diagnostics use. Caution: Federal law restricts this device to sale by or on the order of a licensed practitioner.

The i-STAT CG8+ cartridge is used with the i-STAT 1 analyzer as part of the i-STAT 1 System to measure glucose (Glu) in arterial, venous or capillary 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+ cartridge. Cartridges require two to three drops of whole blood, which are typically 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 acceptance criteria and study proving the device meets those criteria are detailed below, based on the provided FDA 510(k) summary for the i-STAT CG8+ cartridge with the i-STAT 1 System.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a single table with corresponding performance values in the provided document. Instead, performance expectations are implied through the comparison to the predicate device and the presentation of various study results (precision, linearity, detection limits, interference, sensitivity, and method comparison) against established CLSI guidelines or internal thresholds.

However, based on the provided information, a summary of key performance characteristics and their reported values can be presented as follows:

1. Table of Acceptance Criteria and Reported Device Performance (Implied from Study Results)

Note: The acceptance criteria are largely implied by the successful completion and positive results of studies designed according to CLSI (Clinical and Laboratory Standards Institute) guidelines, such as EP05-A3, EP06-Ed2, EP17-A2, EP07-ED3, EP37-ED1, EP09c-ED3, and EP35. Meeting the statistical benchmarks (e.g., specific SD, %CV, R², slope, intercept ranges, or being within "allowable error") for these guidelines indicates that the device's performance is acceptable for its intended use.

Study Details

Here's a breakdown of the study details based on the provided document:

2. Sample Sizes Used for the Test Set and Data Provenance

• Precision Studies:

  • 20-day Precision (Aqueous): N=80 samples per level.
  • Multi-site/Operator Precision (Aqueous): N=90-96 samples per level (across 3 sites).
  • Whole Blood Precision: Venous (N=29-102 per range), Arterial (N=5-105 per range), Capillary (N=15-107 per range).

• Linearity: Whole blood samples of varying glucose levels. Specific N not provided for this section, but typically multiple points across the range are tested.

• Detection Limits (LoQ, LoB, LoD): Whole blood samples (altered to low/blank glucose levels). Specific N not provided.

• Analytical Specificity (Interference): Whole blood samples. Specific N for each substance not provided, but the study was extensive (Table 8 lists many substances).

• Other Sensitivity Studies:

  • Oxygen Sensitivity: Whole blood samples.
  • Hematocrit Sensitivity: Whole blood samples (at low, mid, high hematocrit levels).
  • Altitude: Whole blood samples.

• Method Comparison (with predicate device):

  • N = 547 (pooled data from arterial, venous, and capillary whole blood specimens).

• Matrix Equivalence:

  • N = 297 (venous and arterial whole blood specimens).

• Data Provenance:

  • The document states "collected across multiple point of care sites" for whole blood precision and method comparison studies. It also mentions "at one site" for the 20-day precision study and "at three (3) sites" for the multi-site precision study.
  • The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. However, clinical studies for 510(k) submissions are typically prospective, especially those involving patient samples collected concurrently with the study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• For this type of in vitro diagnostic device (quantitative glucose measurement), the "ground truth" for the test set is established by comparative reference methods, not by expert consensus or interpretations of images by radiologists.
• The document mentions "a comparative method" (i-STAT CHEM8+ and epoc Blood Analysis System for glucose) for the method comparison study. These are legally marketed, validated laboratory or point-of-care devices that serve as the reference standard for measuring glucose.
• No human experts (like radiologists in an imaging study) are used to establish "ground truth" for quantitative lab tests in this context. Their role might be in collecting samples by healthcare professionals, but not in determining the true value of the analyte.

4. Adjudication Method for the Test Set

• Adjudication methods (e.g., 2+1, 3+1) are primarily relevant for imaging studies where human readers interpret data, and discrepancies need to be resolved.
• For quantitative in vitro diagnostic tests like glucose measurement, adjudication of results in the traditional sense is not applicable. The "ground truth" is determined by the output of a reference instrument or method, and performance is assessed by statistical agreement between the new device and the reference.

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

• No, an MRMC comparative effectiveness study was not done.
• This device is an in vitro diagnostic for quantitative measurement of glucose, not an AI-based imaging or diagnostic device that assists human readers. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Yes, the performance characteristics described (precision, linearity, detection limits, interference, sensitivity) represent the standalone performance of the device (i-STAT CG8+ cartridge with i-STAT 1 System).
• The method comparison study also evaluates the device's performance against a reference method independently. Human involvement is primarily in operating the device and collecting samples, not in interpreting or enhancing the device's quantitative output.

7. The Type of Ground Truth Used

• The ground truth for the device's performance evaluation was established using comparative reference methods (e.g., i-STAT CHEM8+ glucose test, epoc Blood Analysis System) which are considered established and validated methods for glucose quantification.
• This is akin to using a gold standard laboratory test result for comparison.

8. The Sample Size for the Training Set

• The provided document is a 510(k) summary for a point-of-care in vitro diagnostic device, not an AI/Machine Learning device.
• Therefore, there is no "training set" in the context of machine learning model development. The device relies on electrochemical detection mechanisms and pre-calibrated algorithms, not on statistical models trained on large datasets in the way AI applications do.
• The studies described are for validation (test set), not training.

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

• As explained in point 8, there is no "training set" for this device in the machine learning sense.
• The fundamental principles and calibration of the glucose sensor (glucose oxidase-based amperometric peroxide detection) are based on established chemical and electrochemical principles in analytical chemistry, refined and validated during product development.

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