(135 days)
The i-STAT CHEM8+ cartridge with the i-STAT 1 System is in the in vitro quantification of sodium, potassium, chloride, ionized calcium, glucose, blood urea nitrogen, creatinine, hematocrit, and total carbon dioxide in arterial or venous whole blood in point of care or clinical laboratory settings.
Sodium measurements are used for monitoring electrolyte imbalances.
Potassium measurements are used in the diagnosis and clinical conditions that manifest high and low potassium levels.
Chloride measurements are primarily used in the diagnosis, monitoring, and treatment of electrolyte and metabolic disorders including, but not limited to, cystic fibrosis, diabetic acidosis, and hydration disorders.
Ionized calcium measurements are used in the diagnosis and treatment of parathyroid disease, chronic renal disease and tetany.
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.
Blood urea nitrogen measurements are used for the diagnosis, and treatment of certain renal and metabolic diseases.
Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Hematoorit 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.
Carbon dioxide measurements are used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
The i-STAT CHEM8+ test cartridge contains test reagents to analyze whole blood at the point of care or in the clinical laboratory for sodium (Na), potassium (K), chloride (CI), ionized calcium (iCa), glucose (Glu), blood urea nitrogen (BUN), creatinine (Crea), hematocrit (Hct), and total carbon dioxide (TCO2). 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.
The provided text describes a 510(k) premarket notification for the i-STAT CHEM8+ cartridge with the i-STAT 1 System, specifically addressing the addition of an anticoagulant-free whole blood matrix. The document references several previous 510(k) clearances for various analytical performance characteristics and presents a new "Matrix Equivalence" study for the anticoagulant-free whole blood.
Here's an analysis of the acceptance criteria and study information provided, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria for the "Matrix Equivalence" study in a tabulated format. However, it implicitly uses a Passing-Bablok linear regression analysis to demonstrate equivalence. The reported device performance is presented as the results of this regression analysis. We can infer the expected performance from general expectations for method comparisons in analytical chemistry, where a slope close to 1, an intercept close to 0, and a high correlation coefficient (r) indicate good agreement.
| Analyte | Units | Candidate Range | Primary Sample Range | r (Correlation Coefficient) | Slope | Intercept |
|---|---|---|---|---|---|---|
| Na | mmol/L | 110 - 174 | 111 - 173 | 0.99 | 1.00 | 0.50 |
| K | mmol/L | 2.2 - 7.7 | 2.2 - 7.5 | 0.96 | 1.00 | 0.00 |
| Cl | mmol/L | 76 - 136 | 79 - 137 | 0.98 | 1.00 | -0.50 |
| iCa | mmol/L | 0.41 - 2.48 | 0.71 - 2.28 | 0.85 | 1.04 | -0.04 |
| Glu | mg/dL | 29 - 663 | 35 - 660 | 1.00 | 1.01 | -0.63 |
| BUN | mg/dL | 4 - 120 | 4 - 118 | 1.00 | 1.00 | 0.00 |
| Crea | mg/dL | 0.2 - 19.4 | 0.2 - 19.4 | 1.00 | 1.00 | 0.00 |
| Hct | %PCV | 16 - 75 | 16 - 73 | 0.99 | 1.00 | 0.46 |
| TCO2 | mmol/L | 9 - 42 | 11 - 41 | 0.95 | 1.00 | 0.00 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set for Matrix Equivalence): The sample sizes vary slightly per analyte:
- Na, Cl, iCa: 314
- K, Glu: 313
- BUN: 310
- Crea: 312
- Hct: 311
- TCO2: 273
- Data Provenance: The study was conducted at "three (3) point of care sites." The document does not specify the country of origin, but given the FDA submission, it is likely the US or a region with equivalent regulatory standards. The data is prospective in nature, as it involved collecting samples (both anticoagulant-free and anticoagulated) for direct comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study (matrix equivalence for IVD devices) does not typically involve human experts establishing "ground truth" in the way a diagnostic imaging study would. The ground truth (or reference method) for comparison is the measurement obtained from the previously cleared device using anticoagulated samples. The expertise lies in the calibration of the reference method and the design and execution of the analytical study, not in human interpretation of results.
4. Adjudication Method for the Test Set
Not applicable for this type of analytical method comparison study. Adjudication is relevant for subjective assessments, typically in diagnostic imaging or clinical outcomes, to resolve discrepancies among human readers or between AI and human readers. Here, the comparison is between two quantitative measurement 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 for an in vitro diagnostic device, not a diagnostic imaging or clinical decision support AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the analytical performance (precision, linearity, LoQ, LoB/LoD, interference, and method comparison) of the i-STAT CHEM8+ cartridge with the i-STAT 1 System, and its equivalence between different sample matrices, primarily represents standalone performance of the device without human intervention beyond sample collection and device operation. The "Matrix Equivalence" study directly compares the results of the device using two different sample types.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the "Matrix Equivalence" study was established by the mean result from the primary sample, which refers to measurements obtained from whole blood samples collected with balanced heparin or lithium heparin anticoagulant using the previously cleared i-STAT CHEM8+ system. This acts as the "reference method" for comparison to the anticoagulant-free samples.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" for the purpose of the Matrix Equivalence study. This study is a validation study demonstrating that a new sample matrix (anticoagulant-free whole blood) yields equivalent results to the established (anticoagulated) sample matrix. The device itself (i-STAT CHEM8+ with i-STAT 1 System) would have undergone extensive development and internal testing (which could be considered a form of "training") prior to its initial clearances (K183678, K183680, K183688, K191298, K191360). The current submission focuses on extending the indications for use.
9. How the Ground Truth for the Training Set was Established
As no explicit "training set" is mentioned for this specific submission's study, this question is not directly answerable from the provided text. The "ground truth" for the reference method within the Matrix Equivalence study, as stated above, derives from the previously cleared performance of the i-STAT CHEM8+ system using anticoagulated samples, which would have been established through robust analytical validation studies (e.g., comparison to laboratory reference methods).
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.