(25 days)
The StatStrip Xpress 2 Glucose Hospital Meter System is intended for point-of-care, in vitro diagnosic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, neonate arterial whole blood and neonate heel stick specimens.
The StatStrip Xpress 2 Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick and neonatal arterial samples throughout all hospital and all professional healthcare settings.
The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick.
It is not intended for use with neonate cord blood specimens.
It is not intended for the screening or diabetes mellitus but is indicated for use in determining dysglycemia.
The Nova Biomedical StatStrip Xpress 2 Glucose Hospital Meter System consists of a hand held meter, test strips, control solutions, and linearity solutions. The test strip contains a reagent (glucose oxidase) that reacts with the glucose in the test sample is applied to the test strip, which is then analyzed in the meter. The reagent test strip contains glucose oxidase and glucose dehydrogenase, which reacts with the glucose in the test sample.
A test strip is inserted into the meter, and the sample is applied to the sample entry end of the strip. When enough sample has been added to the strip (sample is drawn into strip though capillary action) the meter begins its analysis. A digital readout is displayed on the meter in 6 seconds. The system is designed for hospital point of care (POC) use including physicians' office labs.
The provided document discusses the StatStrip Xpress 2 Glucose Hospital Meter System, a point-of-care, in vitro diagnostic device for quantitative determination of glucose. The document is a 510(k) summary and indicates that the proposed device is substantially equivalent to a predicate device (K152986). The only change mentioned is the modification of the lower limit of the operating temperature range from 15°C to 5°C.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific acceptance criteria (e.g., accuracy percentages, bias limits) for the glucose meter's performance. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "Reported Device Performance" is implicitly that the device performs equivalently to the predicate device across all characteristics, with the exception of the broadened operating temperature range, which is stated not to adversely affect safety or efficacy.
The document provides a comparison table (Table 1) between the predicate and proposed devices, which details various characteristics:
| Characteristic | Predicate: StatStrip Xpress 2 Glucose Hospital Meter System (K152986) | Proposed: StatStrip Xpress 2 Glucose Hospital Meter System | Performance Claim / Status |
|---|---|---|---|
| Intended Use | (Detailed description provided in the document) | Same as Predicate | Equivalent |
| Measuring Range | 10-600 mg/dL | Same as Predicate | Equivalent |
| Hematocrit Range | 20-70 % | Same as Predicate | Equivalent |
| Operating Principle | Electrochemical biosensor | Same as Predicate | Equivalent |
| Operating Temperature Range | 59-104°F (15-40°C) | 41-104°F (5-40°C) | Modified/Improved |
| Sample type | (Detailed description provided in the document) | Same as Predicate | Equivalent |
| Sample size | 1.2 uL | Same as Predicate | Equivalent |
| Sample application | Test strip capillary draw | Same as Predicate | Equivalent |
| Handheld meter? | YES | Same as Predicate | Equivalent |
| Meter Calibration | Automatic, no Calibration Code | Same as Predicate | Equivalent |
| Data storage | 400 test results | Same as Predicate | Equivalent |
| Test Time | 6 sec | Same as Predicate | Equivalent |
| Weight | 2.77 oz. | Same as Predicate | Equivalent |
| Bar code scanner | None | Same as Predicate | Equivalent |
| Power source | Two AAA Batteries | Same as Predicate | Equivalent |
| Controls: | Liquid, 3 levels | Same as Predicate | Equivalent |
| Linearity Solutions | Liquid, 5 levels | Same as Predicate | Equivalent |
| Test Strips - Active reagent: | Glucose Oxidase | Same as Predicate | Equivalent |
| Screen Type | Non segmented Color Display | Same as Predicate | Equivalent |
| Location of Strip Port | Bottom of Meter | Same as Predicate | Equivalent |
The document states, "The modification of the lower limit of the operating temperature range from 15°C to 5°C does not adversely affect the safety or efficacy of the device." This statement implies that testing was conducted to prove the device's performance remains acceptable within this extended temperature range, but the specific data or acceptance criteria used for this proof are not detailed in the provided text.
2. Sample Size Used for the Test Set and the Data Provenance
The provided document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective) for the studies supporting the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not available in the provided document. The document pertains to a medical device (glucose meter) rather than an AI or image-based diagnostic system that would typically require expert ground truth labeling.
4. Adjudication Method for the Test Set
This information is not available in the provided document. As mentioned above, this is not typically applicable for a glucose meter's performance evaluation in the same way it would be for an AI diagnostic.
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
This information is not applicable to the StatStrip Xpress 2 Glucose Hospital Meter System, as it is a standalone diagnostic device and not an AI-assisted interpretation tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself, the StatStrip Xpress 2 Glucose Hospital Meter System, operates in a standalone manner to provide glucose measurements. The 510(k) summary implicitly covers the standalone performance of the device without human interpretation of the underlying signal, as it provides a direct digital readout. However, this is distinct from "algorithm only performance" in the context of an AI-driven system that outputs a diagnostic result for human review.
7. The Type of Ground Truth Used
For a glucose meter, the "ground truth" for accuracy studies would typically be established by comparing the device's readings to a laboratory reference method (e.g., a central lab analyzer using a hexokinase or glucose oxidase method) known for its high accuracy and precision. The document does not explicitly state the type of ground truth used, but this is the standard practice for such devices. It's not expert consensus, pathology, or outcomes data in this context.
8. The Sample Size for the Training Set
This information is not available in the provided document. As a traditional medical device (not an AI/machine learning product for which a "training set" is typically discussed), the concept of a training set for an algorithm as a distinct entity is not explicitly mentioned. Development and validation would involve various studies, but not in the framework of training an AI model.
9. How the Ground Truth for the Training Set Was Established
This information is not available in the provided document. See the explanation for point 8.
§ 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.