(169 days)
The HemoCue Glucose 201 RT system is used for quantitative determination of glucose in whole blood supplementing the clinical evidence in the diagnosis and treatment of patients with diabetes. The HemoCue Glucose 201 RT system is for In Vitro Diagnostic use only. The HemoCue Glucose 201 RT Analyzer is only to be used with HemoCue Glucose 201 RT Microcuvettes. For professional use only.
The HemoCue Glucose 201 RT system consists of a small and portable analyzer (photometer) and plastic microcuvettes. The HemoCue Glucose 201 RT Microcuvette contains reagents deposited on its inner walls and serves both as a pipette and as a measuring cuvette. A blood sample of approximately 4 uL is drawn into the cavity by capillary action. The filled microcuvette is inserted into the HemoCue Glucose 201 RT Analyzer. The measurement takes place in the analyzer in which the transmittance is measured and the absorbance and glucose level is calculated.
The HemoCue Glucose 201 RT system is designed for quantitative determination of glucose in whole blood.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list specific numerical acceptance criteria (e.g., accuracy, precision targets in mg/dL or %). Instead, it generally states that the device provides "clinical results comparable to other test methods." This implies that the acceptance criteria are met if the new device's performance is demonstrably equivalent or non-inferior to the legally marketed predicate device (HemoCue Glucose 201 system, K020935) and other established test methods.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance comparable to the predicate device and other test methods in clinical laboratory and point-of-care settings. | "Studies were conducted... to demonstrate the performance of the HemoCue Glucose 201 RT system and that the intended user can easily operate the system and obtain results as expected." |
| "...provide clinical results comparable to other test methods in current clinical laboratory and point-of-care practices." | |
| Ease of operation by intended users. | "...intended user can easily operate the system..." |
| Accurate quantitative determination of glucose in whole blood. | "The measurement takes place in the analyzer in which the transmittance is measured and the absorbance and glucose level is calculated." |
| "The calibration... is traceable to the ID GC-MS method." | |
| Suitable for professional use. | "For professional use only." (Stated in Intended Use) |
| In Vitro Diagnostic use only. | "For In Vitro Diagnostic use only." (Stated in Intended Use) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for the test set. It mentions:
- "Studies were conducted in-house, in clinical laboratory settings and point of care centers..."
This indicates that the data was collected from various settings, suggesting a prospective data collection approach from potentially multiple sites. The country of origin is not explicitly stated, but given the submitter is HemoCue AB in Sweden, and the contact is HemoCue, Inc. in the US, it's plausible the studies were conducted in both Europe and the US.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts or their qualifications for establishing ground truth for the test set. Given it's a glucose measurement device, the "ground truth" would likely be established by a reference method rather than expert consensus on interpretation.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. For a glucose measurement device, the primary validation involves comparison to a reference standard rather than human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
An MRMC study is not applicable to this type of device (a glucose measurement system). MRMC studies typically involve human readers interpreting images or data, which is not the primary function of a glucose meter. Therefore, no effect size of human readers improving with AI vs without AI assistance is reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, this device inherently functions in a standalone (algorithm only) manner. The HemoCue Glucose 201 RT system, consisting of the analyzer and microcuvettes, performs the measurement and calculates the glucose level without direct human interpretation of raw data. The user only provides the blood sample and
reads the displayed result. The description of the device operation and the fact that "the transmittance is measured and the absorbance and glucose level is calculated" within the analyzer confirms its standalone operation.
7. The Type of Ground Truth Used
The ground truth used for this device is based on a traceable reference method:
- "The calibration of the HemoCue Glucose 201 RT system is traceable to the ID GC-MS method."
ID GC-MS (Isotope Dilution Gas Chromatography-Mass Spectrometry) is a highly accurate and precise reference method for glucose determination, often considered a "gold standard."
8. The Sample Size for the Training Set
The document does not specify a separate training set or its sample size. For an in vitro diagnostic device like this, the "training" (calibration) is typically part of the manufacturing process or device design. The device is "factory calibrated" and "needs no further calibration."
9. How the Ground Truth for the Training Set Was Established
Given that the device is "factory calibrated" and its calibration is "traceable to the ID GC-MS method," the ground truth for establishing the device's inherent measurement characteristics and calibration was likely established using samples analyzed by the ID GC-MS reference method. These known concentrations would have been used during the manufacturing and calibration process of the analyzers.
§ 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.