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510(k) Data Aggregation
(41 days)
The i-STAT CG4+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of pH, PO2, PCO2, and lactate in arterial or venous whole blood in point of care or clinical laboratory settings.
pH, PO2, and PCO2 measurements are used in the diagnosis, monitoring, and treatment of respiratory disturbances and metabolic and respiratory-based acid-base disturbances.
Lactate measurements are used in (1) the diagnosis and treatment of lactic acidosis in conjunction with measurements of blood acid/base status, (2) monitoring tissue hypoxia and strenuous physical exertion, and (3) diagnosis of hyperlactatemia.
The i-STAT CG4+ test cartridge contains test reagents to analyze whole blood at the point of care or in the clinical laboratory for pH. PO2 (partial pressure of oxygen), PCO2 (partial pressure of carbon dioxide), and lactate. 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.
Here's a summary of the acceptance criteria and study information for the i-STAT CG4+ Cartridge with the i-STAT 1 System, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" for each performance characteristic in a pass/fail format. Instead, it presents study results and concludes that the device is "substantially equivalent" to predicate devices. However, we can infer some criteria from the reported performance, especially in precision and linearity compared to typical clinical expectations.
| Performance Characteristic | Acceptance Criteria (Implied/Inferred) | Reported Device Performance |
|---|---|---|
| Precision (Aqueous Materials) | Acceptable Total CV% (Specific values for each analyte and level) | pH: Total CV% ranged from 0.03% to 0.07% across 5 levels. PO2: Total CV% ranged from 1.9% to 3.5% across 5 levels. PCO2: Total CV% ranged from 1.5% to 3.4% across 5 levels. Lactate: Total CV% ranged from 0.4% to 2.7% across 5 levels. |
| Precision (Whole Blood) | Acceptable SD and CV% within specified sample ranges for venous and arterial blood | pH (Venous): SDs from 0.0030 to 0.0064, CV% from 0.04 to 0.09. pH (Arterial): SDs from 0.0047 to 0.0060, CV% from 0.06 to 0.08. PO2 (Venous): SDs from 0.9 to 12.4, CV% from 0.7 to 3.4. PO2 (Arterial): SDs from 0.5 to 8.5, CV% from 1.2 to 4.4. PCO2 (Venous): SDs from 0.29 to 0.77, CV% from 0.8 to 1.7. PCO2 (Arterial): SDs from 0.37 to 0.90, CV% from 0.5 to 2.1. Lactate (Venous): SDs from 0.016 to 0.200, CV% from 1.14 to 2.26. Lactate (Arterial): SDs from 0.018 to 0.036, CV% from 0.42 to 2.49. |
| Linearity | Demonstrated linearity over the reportable range (e.g., r² > 0.99) | pH: Slope 0.966, Intercept 0.246, r² 0.9983 PO2: Slope 1.005, Intercept -0.196, r² 0.9988 PCO2: Slope 1.027, Intercept -1.084, r² 0.9978 Lactate: Slope 1.128, Intercept 0.104, r² 0.9966 |
| Limit of Quantitation (LoQ) | LoQ to be below the lower limit of the reportable range | pH: Determined LoQ 6.716 (LLR ≤ 7.000) PO2: Determined LoQ 10 mmHg (LLR ≤ 15 mmHg) PCO2: Determined LoQ 9.7 mmHg (LLR ≤ 15.0 mmHg) Lactate: Determined LoQ 0.27 mmol/L (LLR ≤ 0.30 mmol/L) |
| Limit of Blank (LoB) / Limit of Detection (LoD) | LoB and LoD for Lactate to be within acceptable limits | Lactate: LoB 0.15 mmol/L, LoD 0.19 mmol/L |
| Oxygen Sensitivity (Lactate) | Insensitive to oxygen changes between 20 to >500 mmHg (equivalence demonstrated) | The study demonstrated that the i-STAT Lactate test is insensitive to oxygen changes between 20 to >500 mmHg. |
| Interference | No significant interference (difference between control and test samples within allowed error (Ea)) (Note: Bromide and Glycolic Acid were identified as interferents for Lactate, with specific effects reported) | pH, PO2, PCO2: No interference found for Acetaminophen, Atracurium, Calcium, Ethanol, Ibuprofen, Morphine, Potassium, Sodium, Bilirubin, Hemoglobin, Triglyceride, Intralipid, Thiopental. Lactate: No interference for Acetaldehyde, Acetaminophen, N-Acetyl-Cysteine, Ascorbic Acid, β-Hydroxybutyric Acid, Bilirubin, Dopamine, Formaldehyde, Hemoglobin, Hydroxyurea, Pyruvate, Salicylate, Thiocyanate, Triglyceride, Intralipid, Uric Acid. Interference identified for Bromide (decreased results ≥ 40.7 mmol/L) and Glycolic Acid (increased results ≥ 1.18 mmol/L). |
| Method Comparison | Acceptable correlation with predicate device (e.g., high r-value, slope near 1, intercept near 0) | pH: N=316, Slope 1.05, Intercept -0.34, r 0.97 PO2: N=308, Slope 1.03, Intercept -3.96, r 0.99 PCO2: N=327, Slope 1.01, Intercept -1.29, r 0.99 Lactate: N=246, Slope 0.96, Intercept 0.08, r 1.00 |
2. Sample Sizes Used for the Test Set and Data Provenance
- Precision (Aqueous Materials): The "test set" for this was aqueous materials. N values for each level were 80 or 81. Provenance is not explicitly stated beyond "at one site." It's an analytical performance study, not involving human subjects directly.
- Precision (Whole Blood): The "test set" for this involved whole blood venous and arterial specimens. Sample sizes (N) varied by sample type and range for each analyte (e.g., pH venous <7.30 had N=20). Provenance: "data collected across multiple point of care sites." This implies prospective collection from various clinical settings.
- Linearity: Whole blood samples of varying analyte levels. Sample sizes are not explicitly stated for individual samples, but the study design evaluated the linearity of the tests using these blood samples. The regression summary provides an R² value for each analyte, indicating the strength of the linear relationship.
- Limit of Quantitation (LoQ): Whole blood altered to low concentrations. Sample size not specified, but utilized "two cartridge lots for each test."
- Limit of Blank (LoB) / Limit of Detection (LoD): Whole blood altered to "blank" and "low" lactate concentrations. Sample size not specified, but results based on the maximal value obtained for "each lot tested."
- Oxygen Sensitivity: Whole blood with high and low ranges of oxygen. Sample size not specified.
- Interference: Whole blood samples. Sample sizes not specified for individual interfering substances.
- Method Comparison:
- pH: N=316
- PO2: N=308
- PCO2: N=327
- Lactate: N=246
Provenance: "Lithium heparin venous and arterial blood specimens were evaluated." This implies prospective collection or re-analysis of existing clinical samples. Country of origin not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes the analytical performance of an in vitro diagnostic device (blood gas and lactate analyzer). The "ground truth" for these types of studies is typically established by comparative methods using highly accurate and precise laboratory-grade instruments or reference methods. It does not involve human expert consensus in the way a medical imaging AI would for diagnosis.
For the method comparison, the comparative methods used were:
- pH, PO2, and PCO2: Radiometer ABL800 FLEX
- Lactate: epoc® Blood Analysis System
These are established clinical laboratory devices, and their measurements form the "ground truth" for comparison. The expertise lies in the certified reference materials and the robust design of these predicate devices, which are regularly calibrated and validated. No individual human experts were mentioned to establish "ground truth" for the test set in the traditional sense of consensus reading in AI studies.
4. Adjudication Method for the Test Set
Not applicable to this type of analytical performance study. Adjudication methods (like 2+1, 3+1) are typically used in studies where human interpretation (e.g., radiologist reads) needs to be reconciled to establish a ground truth for evaluating AI systems. Here, the comparison is against established analytical methods.
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 of an in vitro diagnostic device, not a human-in-the-loop AI system for interpretation. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is an analytical instrument, so its performance is inherently "standalone" in generating a numerical result. The measurements generated (pH, PO2, PCO2, Lactate) are numerical outputs. The studies described (precision, linearity, LoQ, interference, method comparison) directly assess this standalone performance against reference methods or defined standards.
7. The Type of Ground Truth Used
The ground truth used for performance evaluation was:
- Certified Reference Materials / Aqueous Controls: For precision studies (aqueous materials).
- Measurements from Predicate Devices / Comparative Methods: For the method comparison study (Radiometer ABL800 FLEX for pH, PO2, PCO2, and epoc® Blood Analysis System for Lactate). These are considered highly accurate and serve as the clinical reference values.
- Spiked Samples / Altered Whole Blood Samples: For linearity, LoQ, LoB/LoD, and interference studies, where known concentrations or conditions are created and measured against expected values.
8. The Sample Size for the Training Set
Not applicable. This is an analytical device, not a machine learning or AI algorithm that requires a "training set" in the context of supervised learning. The device is designed based on electrochemical principles, and its performance is validated through traditional analytical studies.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device. The device's underlying principles are physics and chemistry-based rather than learned from data.
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