(86 days)
The StatStrip Xpress 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, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens.
The StatStrip Xpress 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 whole blood 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 diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.
The StatStrip Xpress Glucose Hospital Meter System is a hand-held testing device that works in conjunction with the StatStrip Glucose Test Strips. Meter operation is self-prompting using a segmented liquid crystal display (LCD) and icons. Function and data selection is accomplished using 3 push buttons. The handheld meter supports audible alerts and prompts with a built-in beeper. In addition to measuring glucose, the meter also stores up to 400 patient test records. The user can recall and review test results. A single coin battery powers the device, and is expected to perform up to 600 tests before needing to be replaced. A low battery prompt will appear when it is time to replace the battery. All test data is stored in a non-volatile form to prevent data loss.
The StatStrip Glucose Hospital Meter Test Strips are designed with an electrode that measures Glucose levels. Glucose in the blood sample mixes with reagent on the test strip that produces an electric current. The amount of current that is produced depends on how much Glucose is in the blood. 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.
The StatStrip Control Solutions are aqueous solutions that contain no products of human origin. There are three levels of control solutions (Levels 1-3). StatStrip Glucose Control Solutions are intended to verify the accuracy of the blood Glucose test results.
The StatStrip Glucose Linearity Solutions are aqueous materials with a known concentration of glucose intended to verify performance of the Nova Biomedical Analyzers. There are five levels of linearity solutions (Levels 1-5). The Linearity Solution is intended for monitoring the performance (linearity) of the StatStrip Glucose Hospital Meter System.
Here's a breakdown of the acceptance criteria and study information for the StatStrip Xpress Glucose Hospital Meter System, based on the provided text:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It specifically states: "The StatStrip Xpress Glucose Hospital Meter System that is the subject of this submission is identical in form, fit and function, to the device originally cleared in K070960." And also, "The StatStrip Glucose Hospital Meter Test Strips that are the subject of this submission are identical in form, fit, function and packaging, to the qlucose test strips originally cleared for use with the system in K070960."
Therefore, the performance testing described is likely a verification that the new model performs identically to the predicate, rather than a full de novo validation of a completely new device. This means the detailed acceptance criteria and standalone performance would have been established during the clearance of the predicate device (K132121) or the original device (K070960). The current document reports that the new device meets the same performance standards as that predicate.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" for the StatStrip Xpress Glucose Hospital Meter System in this 510(k) submission. Instead, it highlights that the device is "identical in form, fit and function" to its predicate and that "The results of the performance verification testing confirmed that the StatStrip Xpress Glucose Hospital Meter System is safe and effective for its intended purpose and that the StatStrip Xpress Glucose Hospital Meter System is substantially equivalent to the predicate StatStrip Glucose Hospital Meter System (K132121)."
The comparison table (Table 2-1) emphasizes the sameness between the predicate and the modified device for key technical characteristics, implying that the performance met the same standards as the predicate.
Here's an inferred table based on the common characteristics of blood glucose meters and the affirmation of substantial equivalence:
| Characteristic | Acceptance Criteria (Inferred from Predicate's Performance) | Reported Device Performance (StatStrip Xpress) |
|---|---|---|
| Measuring Range | 10-600 mg/dL (as per predicate) | Same (10-600 mg/dL) |
| Hematocrit Range | 20-65% (as per predicate) | Same (20-65%) |
| Sample Size | 1.2 µL (as per predicate) | Same (1.2 µL) |
| Time to Result | ~6 seconds (as per predicate) | Same (~6 seconds) |
| Accuracy/Precision | Meets the clinical and analytical performance claimed for the predicate device (K132121 and K070960). While specific metrics (e.g., % within +/-15mg/dL) are not given here, this would be a core requirement. | "The results of the performance verification testing confirmed that the StatStrip Xpress Glucose Hospital Meter System is safe and effective for its intended purpose and that the StatStrip Xpress Glucose Hospital Meter System is substantially equivalent to the predicate..." |
| Calibration | Automatic, no calibration code (as per predicate) | Same (Automatic, no Calibration Code) |
| Quality Control | Operates with 3 levels for QC (as per predicate) | Same (3 levels) |
| Linearity | Operates with 5 levels for linearity (as per predicate) | Same (5 levels) |
| Intended Use Adherence | Matches the predicate's intended use | Matches the predicate's intended use |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "The results of the performance verification testing confirmed that the StatStrip Xpress Glucose Hospital Meter System is safe and effective for its intended purpose and that the StatStrip Xpress Glucose Hospital Meter System is substantially equivalent to the predicate StatStrip Glucose Hospital Meter System (K132121)."
However, the specific sample sizes used for the performance verification testing of the StatStrip Xpress Glucose Hospital Meter System are not detailed in this 510(k) summary. It refers to "performance verification testing" but does not provide details on the number of samples, patients, or the specific types of clinical studies (e.g., prospective, retrospective, country of origin).
Given the context of a 510(k) where the device is described as "identical in form, fit and function" to a cleared predicate, the new submission primarily validates that the manufacturing process or minor changes do not negatively impact performance, usually through bench testing and often a limited clinical bridging study. The extensive clinical performance data would have been submitted with the original (K070960) or predicate (K132121) devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For blood glucose meters, the "ground truth" (or reference method) is typically established by laboratory-based glucose analyzers, which are themselves highly standardized and calibrated. Expert consensus is generally not the primary method for establishing ground truth in this context.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in imaging studies where subjective expert interpretation is required. For a quantitative device like a blood glucose meter, the ground truth is established by a reference laboratory measurement, and thus adjudication methods are not applicable nor mentioned in this context.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. MRMC studies are relevant for reader-dependent diagnostic tools, often in imaging. A blood glucose meter is a direct quantitative measurement device, not one that relies on human interpretation for its primary output.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
For a blood glucose meter, the device itself is the "standalone" algorithm. The performance of the meter system (meter + test strip) is what is always evaluated. Therefore, yes, a standalone performance study was implicitly done as part of the "performance verification testing" where the device's measurements are compared against a reference method. The results of this testing led to the conclusion of substantial equivalence.
7. Type of Ground Truth Used
The ground truth for blood glucose measurements is almost universally established by a reference laboratory method, typically an enzymatic reference method (e.g., hexokinase method) performed on a laboratory analyzer, which is highly accurate and precise. While not explicitly stated for this specific submission's "performance verification," this is the standard for glucose meter ground truth. The document supports this by stating the device is "intended to provide plasma equivalent results to laboratory methods."
8. Sample Size for the Training Set
The document is a 510(k) submission for a device described as "identical in form, fit and function" to a predicate. This implies that the underlying algorithms and device design were already well-established and "trained" during the development of the original (K070960) and predicate (K132121) systems.
Therefore, the concept of a separate "training set" for this specific submission is not directly applicable or discussed. Any "training" would have occurred during the development phase of the prior, substantially equivalent devices, not for this specific K150461 submission, which verified performance of an identical design.
9. How the Ground Truth for the Training Set Was Established
As mentioned above, the notion of a 'training set' for this specific submission is not relevant as it's a re-submission of an "identical" device. For the original development of such a device, the ground truth for any data used in algorithm development (if machine learning was involved, which is unlikely for a simple electrochemical biosensor calculation) would also have been established via reference laboratory methods, as described in point 7.
§ 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.