(79 days)
The GlucoVitaal H1A Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, forearm, upper arm, thigh, or calf. The GlucoVitaal H1A Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The GlucoVitaal H A Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes controls. The Gluco Vitaal H1 A Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The GlucoVitaal H1A Blood Glucose Test Strips are for use with the Glood Glucose Test Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, forearm, upper arm, palm, thigh, or calf.
The GlucoVitaal H1A Glucose Control Solution is for use with the GlucoVitaal H1A Blood Glucose Test Meter and Test strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.
The GlucoVitaal H1A Blood Glucose Monitoring System consists of GlucoVitaal H1A Blood Glucose Test Meter, GlucoVitaal H1A Blood Glucose Test Strips, GlucoVitaal H1A Glucose Control Solution 1 and Control Solution 2, a Lancing device. Control Solution 1 and Control Solution 2 are required but not included with the meter. Control Solution 1 and Control Solution 2 are always provided as a set.
The provided text describes a 510(k) premarket notification for the GlucoVitaal H1A Blood Glucose Monitoring System, seeking substantial equivalence to a predicate device (CERA-CHEK 1070 Blood Glucose Monitoring System).
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a regulated performance standard. Instead, it aims to demonstrate substantial equivalence to a predicate device by comparing various specifications. The "reported device performance" is not given as numerical results against predefined criteria, but rather as statements of identical or similar specifications to the predicate device.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (GlucoVitaal H1A) |
|---|---|
| Detection Method | Amperometry (Same as Predicate) |
| Enzyme | Glucose dehydrogenase (FAD-GDH) (Same as Predicate) |
| Test Time | 5 seconds (Same as Predicate) |
| Memory | 1000 blood glucose test results with date and time (Same as Predicate) |
| Sample Volume | 0.5 uL (Same as Predicate) |
| Humidity range | 10-85% (Same as Predicate) |
| Temperature range | 50-104°F (10-40°C) (Same as Predicate) |
| Power (Battery) | One 3-volt lithium battery (CR2032) (Same as Predicate) |
| Test range | 20-600 mg/dL (Same as Predicate) |
| Level of QC | 2 Levels (Control 1, Control 2) (Same as Predicate) |
| Dimensions | 94mm(H) x 53.6(W) x 14.9mm(T) (Same as Predicate) |
| Weight | 35g (Same as Predicate) |
| Hematocrit range | 10-70% (Same as Predicate) |
| Code Setting | No code (Predicate device required a code key; candidate device has one built-in) |
| Language | English, Spanish and Portuguese (Predicate device only had English) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for any test set or the data provenance. It focuses on comparing specifications and features for substantial equivalence, rather than presenting a performance study with detailed results from a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The submission is for a blood glucose monitoring system, which typically relies on laboratory reference methods (e.g., YSI analyzer) for ground truth, not expert human readers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided in the document given the nature of the device and the substantial equivalence claim. Adjudication methods are typically relevant for image-based diagnostic systems where human interpretation can vary.
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
An MRMC comparative effectiveness study is not applicable and not mentioned in the document. This type of study is relevant for AI-assisted diagnostic tools involving human interpretation, which is not the case for a blood glucose monitoring system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
While the device itself operates "standalone" in measuring glucose, the document does not describe a specific performance study in terms of an algorithm-only evaluation. Instead, it asserts that the modification of code setting (from code key to no code) would have "no effect on the performance test," implying that prior performance data (likely from the predicate device) is considered relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used for any performance evaluation. However, for blood glucose monitoring systems, the ground truth is typically established using a highly accurate laboratory reference method, such as a YSI glucose analyzer.
8. The sample size for the training set
The document does not mention a training set or its sample size. This is a 510(k) submission focused on substantial equivalence to an existing device, not the development and training of a novel algorithm from scratch.
9. How the ground truth for the training set was established
Since no training set is mentioned, the method for establishing its ground truth is not provided.
§ 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.