(36 days)
The CareSide™ Glucose cartridge is intended for in vitro diagnostic use in conjunction with the Exigent Diagnostics CareSide™ Analyzer to quantitatively measure glucose concentration in whole blood, plasma or serum by laboratory professionals. The CareSide™ Glucose test aids in the diagnosis and treatment of glucose regulation disorders such as diabetes.
For in vitro diagnostic use with Exigent Diagnostics' CareSide™ Analyzer to measure glucose from anti-coagulated whole blood, plasma or serum specimens to aid in the diagnosis and management of disorders of blood glucose regulation such as diabetes.
CareSide™ Glucose cartridges are used with the Exigent Diagnostics CareSide™ Analyzer to measure glucose concentration in whole blood, plasma or serum specimens. The CareSide™ Glucose cartridge, a single use disposable in vitro diagnostic test cartridge, aids in specimen separation and delivers a measured volume of plasma or serum to a dry film to initiate the measurement of glucose concentration. The film cartridge (patent pending) contains all reagents necessary to measure glucose concentration.
Each Exigent Diagnostics CareSide™ Glucose cartridge consists of a glucose-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the whole blood, serum, or plasma specimen into the cartridge sample deposition well, closes the lid and inserts the cartridge into the Exigent Diagnostics CareSide™ Analyzer.
Once loaded, the CareSide™ analyzer scans the cartridge barcode, spins the cartridge to move the sample from the sample deposition well into the cartridge channels and chambers, and brings the cartridge and the contained specimen to 37℃. As the cartridge continues to spin, the blood cells are separated from the plasma/serum and the cells accumulate in the separation well. Approximately ten microliters of plasma (or serum, as applicable) remain in the metering passage. Any excess sample flows into an overflow well.
The plasma (or serum, as applicable) is automatically dispensed onto the multi-layer reagent film. The spreading layer distributes the sample evenly on the film. Protein is removed before the glucose solution diffuses through the reflection layer and reaches the reaction layer. In the reaction layer glucose reacts with oxygen via a glucose oxidasecatalyzed reaction to produce hydrogen peroxide which in turn participates in a peroxidase-catalyzed reaction with the substrate to produce a red dye. The color intensity, as measured by the amount of light reflected at 505 nanometers, is directly related to the specimen glucose concentration.
Test Reaction Sequence:
B-D-glucose + O2 + H2O __ slucoseoxidase > D-gluconic acid + H2O2 peroxiduse > Red dye 1,7-dihydroxynaphthalene + 4-aminoantipyrine + 2 H2O2-
As the cartridges spin, photodiodes measure reflectance of light emitted by wavelengthspecific light emitting diodes (LEDs) at a fixed time. The analyzer uses the reflectance measurements and the lot-specific standard curve to calculate glucose concentration.
The provided text describes the CareSide™ Glucose device and its premarket notification, including a comparison to a predicate device. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a separate section with specific numerical thresholds for various performance metrics. Instead, it presents performance characteristics and compares them to a predicate device, implying that performance "as well as or better than" the predicate device is the de facto acceptance criterion for substantial equivalence.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported CareSide™ Glucose Performance | Predicate Device (Vitros Glucose DT) Performance |
|---|---|---|---|
| Detection Limit | ≥ 20 mg/dL | 20 mg/dL | 20 mg/dL |
| Reportable Range | ≥ 20 to 450 mg/dL | 20 to 600 mg/dL | 20 to 450 mg/dL |
| Accuracy | Comparable to Predicate | Mean recovery 98% | Not provided |
| Precision | Comparable to Predicate | Total CV, 94 mg/dL, 5.8% | Total CV, 117 mg/dL, 1.4% |
| Method Comparison | High correlation with Predicate | CareSide™ = 1.04 (Vitros Glucose DT) - 7.0 mg/dL, r = 1.00 | N/A |
| Linearity | High correlation | Mean deviation approx 99%, r = 1.00 | Not provided |
| Interference | Less or equal interference | No significant interference observed at tested concentrations of: Ascorbic Acid, Bilirubin, Creatinine, Hemoglobin, Protein, Triglycerides, Uric Acid | Interference observed for: Ascorbic acid, Hemoglobin @ 250 mg/dL, Protein 10 g/dL |
| Specimen Types & Anticoagulants | Comparable utility | No clinically significant difference between heparinized whole blood, serum, heparin plasma, and EDTA plasma. | No clinically significant difference between serum, heparin plasma, or EDTA plasma. Whole blood is unsuitable. |
| Expected Values | Comparable to Predicate | 68 to 101 mg/dL (fasting) | 65 - 110 mg/dL (fasting) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the clinical test set. The data provenance is not specified, but it's implied to be retrospective as part of a 510(k) submission showcasing performance data that has already been collected. The studies appear to be laboratory-based evaluations rather than specific patient trials with details on country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the test set. The performance data presented appears to be direct measurements and comparisons rather than subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader, multi-case (MRMC) comparative effectiveness study is mentioned. The device is an in vitro diagnostic (IVD) for quantitative measurement of glucose, not an imaging device or one requiring human reader interpretation in the same way. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable in this context.
6. Standalone (Algorithm Only) Performance Study
Yes, the entire document is essentially a description of the standalone performance of the CareSide™ Glucose device (algorithm and integrated system) without human-in-the-loop performance influencing the measurement itself. The device is designed to quantitatively measure glucose.
7. Type of Ground Truth Used
The ground truth used for performance evaluation is established by a "Reference Method" which is Hexokinase. This is a well-established enzymatic method for glucose measurement, considered a gold standard in clinical chemistry.
8. Sample Size for the Training Set
The document does not provide information on the sample size used for the training set. As it refers to a device for quantitative chemical analysis, the "training set" might refer to samples used for initial calibration, method development, and optimization rather than a dataset for machine learning in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
The document does not explicitly state how the ground truth for the training set was established. However, given the nature of the device (quantitative glucose measurement), it is highly probable that the ground truth for both training/development and testing would be established using a recognized reference method like the Hexokinase method, as indicated for the "Reference Method."
§ 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.