(84 days)
The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, 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 throughout all hospital and all professional healthcare settings, including patients receiving intensive medical intervention/therapy.
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 StatStrip Glucose Hospital Meter System was previously cleared under K150281. The purpose of this dual 510(k) and CLIA Waiver submission for the StatStrip Glucose Hospital Meter System is to expand the indication for use to include the use of capillary specimens on patients receiving intensive medical intervention/therapy and support a CLA Waived categorization for this expanded indication for use to include the quantitative determination of glucose in capillary finger stick throughout all hospital and all professional healthcare settings. No changes have been made to the software, the test strips, controls or linearity solutions.
The system contains the following:
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- StatStrip Meter, with integrated Wi-Fi connection and antenna option
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- Charging Station
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- Vial of StatStrip Test Strips
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- Battery (3.7 V Lithium)
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- Quick Reference Guide
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- Instructions for Use Manual
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- StatStrip Log Book
Offered separately:
- . StatStrip Test Strips
- Quality Control Solutions, Level 1, 2, 3
- Linearity Solutions, Levels 1, 2, 3, 4, 5.
Meter: The StatStrip Glucose Hospital Meter is a hand-held testing device that works in conjunction with Nova StatStrip Glucose test strips to measure glucose in a whole blood sample. Meter operation is selfprompting using an illuminated touch-screen Graphical User Interface (GUI). In addition to measuring glucose, the meter also stores patient test data, quality control test data and other information relating to the patient, patient sample, operator, reagents and meter.
The self-prompting menu system is navigated by means of a combination of touch-panel on-screen keys, on-screen soft keyboard. The operator can use a finger or a PDA stylus to select options for the onscreen display. It offers audible feedback for user inputs, and audible and/or visual feedback for prompts and user alerts. The Meter also has a barcode scanner that automates data entry.
The rechargeable batteries provide sufficient power to operate for 8 hours before requiring recharging. A "battery fuel gauge" bitmap constantly informs the user as to the current state of charge on the battery. Battery charge state information is available on the "meter Welcome screen". The meter will shutoff (Sleep) after 90 seconds of inactivity. Test data and meter setup information will be stored in a nonvolatile form to prevent data loss.
Charging (Docking) Station: The meter charging station is a stationary accessory used to recharge the meter. The charging station has one slot for the meter to be placed for charging and a slot for an extra battery to be charged.
The charging station should be located central to the patient care area being served by the meter (e.g. a nursing station). The data charging station must remain plugged in to a wall outlet for power.
The system still allows the charging station to be used to transfer data from the meter to a central workstation, and allow meter setup information to be downloaded from the central workstation to the meter.
Test Strips: The test strips contain a reaction layer that contains a glucose-enzyme (greater than 1.0 IU) and ferricvanide as a mediator. The test strip is touched to a drop of blood to initiate the test process. The strip is designed such that when a drop of blood is touched to the strip, the blood is drawn into the reaction space via capillary action. A simple one-step process provides a blood glucose result. Test strips will be sold in vials of 25 strips.
Control Solutions: The control solutions are aqueous assayed solutions, containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dye). They contain no products of human origin. There are three levels of controls, (Level 1, Level 2 and Level 3). These solutions will be offered for sale separately from the meter.
Linearity Solutions: There are 5 levels of Linearity solutions containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dye). They contain no products of human origin. These solutions are offered separately from the system for users to verify the performance of the system.
Replacement batteries will be offered separately.
Wi-Fi Option: The StatStrip Glucose Hospital Meter provides a Wi-Fi communication method with a healthcare facility's network system. The wireless radio chipset utilizing the IEEE 802.11 alb/g communication protocols (Wi-Fi) is used as an optional means to transmit and receive test results, previously cleared under K150281.
The provided text describes the Nova Biomedical Corporation's StatStrip Glucose Hospital Meter System. Here's a breakdown of the acceptance criteria and study information:
Acceptance Criteria and Device Performance for StatStrip Glucose Hospital Meter System
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for glucose meters, particularly those for critical care, typically align with ISO 15197 standards or internal company-defined standards that demonstrate clinical agreement. While explicit "acceptance criteria" are not given in quantitative terms like "must achieve X% within Y mg/dL," the clinical study performance data serves as the reported performance against FDA's substantial equivalence requirements. Therefore, the "acceptance criteria" can be inferred from the performance metrics demonstrated.
Interpreted Acceptance Criteria (Based on Study Performance):
- **For glucose concentrations =75 mg/dL). This suggests that after filtering or specific data points, these are the totals used for analysis.
- Data Provenance: Retrospective data mining ("real world evidence") from two leading medical centers in the U.S. (one in Minnesota and one in Maryland). These were described as CLIA Waived retrospective studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The ground truth was established by a central laboratory comparator method.
4. Adjudication method for the test set:
This information is not provided in the document.
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 is not applicable. The device is a glucose meter, not an imaging device or AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Yes, the studies assessed the performance of the StatStrip Glucose Hospital Meter System (algorithm-driven device) by comparing its readings to a central laboratory comparator method. This is essentially a standalone performance evaluation of the device itself. The "CLIA Waived operators" used the device, but the performance being measured is of the device's accuracy compared to a gold standard, not the operator's diagnostic ability.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth was established using plasma glucose specimens obtained from either an arterial or venous specimen as measured on a central laboratory comparator method, specifically an IDMS traceable hexokinase comparator method (Roche Cobas System, Roche Diagnostics, Indianapolis, IN). This is considered a highly accurate and standardized laboratory method for glucose determination.
8. The sample size for the training set:
This information is not provided in the document. The document describes clinical studies for performance evaluation for a 510(k) submission, not specifically developmental or training data for the device's underlying technology. The device itself was previously cleared (K150281) and this submission is an expansion of its indication for use, implying the core technology was already developed and validated.
9. How the ground truth for the training set was established:
This information is not provided in the document, as the document focuses on the expanded indication's validation rather than the initial device development.
§ 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.