(87 days)
The StatStrip Xpress 2 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 throughout all hospital and all professional healtheare 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 Xpress 2 Glucose Hospital Meter is a hand-held, battery-powered, in vitro diagnostic laboratory instrument that works in conjunction with Nova Biomedical glucose electrochemical test strips to measure glucose in a whole blood sample, a Quality Control (QC) solution, linearity, or proficiency solutions. In addition to measuring glucose, the meter stores patient test data, and other information relating to patient sample, operator, reagents, and the meter. The meter can store up to 400 patient and/or quality control test results. The user can review all stored test results on screen. Functions and data selection are accomplished by 3 push buttons. The meter has a built-in beeper for audible alerts and prompts.
The StatStrip Glucose Hospital Meter Test Strips are intended for use with the StatStrip Xpress 2 Glucose Hospital Meter System.
The Nova StatStrip Glucose Control Solutions are used as a quality control check to ensure that the StatStrip Xpress 2 Glucose Hospital Meter and the Glucose Test Strips are working properly as a system.
The Nova StatStrip Glucose Linearity Solutions are used to check the linearity of the Nova StatStrip Xpress 2 Glucose Hospital Meter.
The provided text describes a 510(k) premarket notification for the StatStrip Xpress 2 Glucose Hospital Meter System. It states that the purpose of this submission is to change the labeling to include the use of capillary whole blood specimens in all hospital and professional healthcare settings, including for patients receiving intensive medical intervention/therapy. Crucially, it highlights that this expanded indication was previously cleared for the predicate device, StatStrip Glucose Hospital Meter System (K181043), and no changes have been made to the candidate device itself, the test strips, controls, or linearity solutions since its prior clearance (K163490).
Therefore, the submission is not focused on proving the device meets new acceptance criteria through a new study, but rather on demonstrating substantial equivalence to a predicate device that already had this expanded indication cleared. The document implies that the device inherently meets these criteria because it is identical to a previously cleared device for the expanded use.
Given this context, if we were to infer "acceptance criteria" and "study" from the provided text, it would be based on the original clearance of the predicate device (K181043) for the expanded indication, or the original clearance of the candidate device (K163490) for its initial indications. However, the current document does not detail those studies.
Therefore, many of the requested items (sample size, data provenance, expert ad-judgement, MRMC studies, standalone performance, training set details) are not described in the provided text because this 510(k) relies on the substantial equivalence principle, not on a new study for the device itself to prove the expanded indication.
Here's a breakdown of what can be inferred or directly stated from the text, and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or performance data from a new study specific to this K182549 submission. It states: "The expanded indication proposed in this submission was previously cleared for the predicate device (K181043). No changes have been made to the candidate device, the software, the test strips, controls or linearity solutions since the K163490 clearance therefore; there are no additional safety and efficacy concerns to the device." This implies that the performance data for this expanded indication was deemed acceptable in the predicate device's clearance.
However, the "Comparison of Predicate and Candidate devices" table (Page 5-6) lists technological characteristics that could act as implied performance specifications or features if a study were to be conducted. Since no new study is described, this is a comparison of design, not performance data from a new study.
| Item | Predicate Device (K181043) StatStrip Glucose Hospital Meter System | Candidate Device StatStrip Xpress 2 Glucose Hospital Meter System | Implied Acceptance Criteria (based on device specs) | Reported Device Performance (as stated in document, no new study performance data presented) |
|---|---|---|---|---|
| Intended Use | Quantitative determination of glucose in capillary finger stick, venous whole blood, arterial 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. | Same | Device successfully determines glucose in specified samples and settings. | Stated to be the same and previously cleared. No new performance data provided in this document. |
| Operating Principle | Electrochemical biosensor | Same | Operates as an electrochemical biosensor. | Achieved (by identity to predicate). |
| Measuring Technology | Enzyme, Amperometric Glucose Enzyme (Aspergillus sp., >1.0 IU) | Same | Uses specified enzyme and amperometric technology. | Achieved (by identity to predicate). |
| Sample type | Capillary whole blood (finger stick), venous whole blood, arterial whole blood, neonatal heel stick, and neonatal arterial whole blood samples | Same | Compatible with specified sample types. | Achieved (by identity to predicate). |
| Sample size | 1.2 $μ$ L | Same | Requires 1.2 $μ$ L sample. | Achieved (by identity to predicate). |
| Measuring range | 10-600 mg/dL | Same | Accurately measures within 10-600 mg/dL. | Achieved (by identity to predicate). |
| Hematocrit range | 20-65% | Same | Functions correctly within 20-65% hematocrit. | Achieved (by identity to predicate). |
| Time to Result | ~ 6 seconds | Same | Produces result in ~6 seconds. | Achieved (by identity to predicate). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified. The document does not describe a new study or test set for this 510(k) submission. It relies on the previous clearance of the predicate device for the expanded indication.
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)
- Not applicable/Not specified. Since no new human-expert based ground truth for a test set is described, this information is not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. No new test set or adjudication process is described.
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
- Not applicable. This device is a blood glucose meter, not an AI imaging analysis system that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. A blood glucose meter operates as a standalone device, providing a quantitative result without human "interpretation" of a complex output. The "performance" of such a device is typically assessed as an algorithm (meter software) reading a biochemically induced electrical signal. However, the document does not describe the specific standalone performance study from this submission, but rather refers to prior clearances.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For a blood glucose meter, the ground truth would typically be established by a reference method (e.g., a laboratory-grade glucose analyzer, often using enzymatic or hexokinase methods) that is highly accurate and precise. This is implied by the nature of glucose measurement, but not explicitly stated in this document for this submission.
8. The sample size for the training set
- Not specified. No details on training sets are provided, as this is not a de novo AI/ML device submission. The device is based on established electrochemical biosensor technology.
9. How the ground truth for the training set was established
- Not specified. (See 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.