(167 days)
The On Call® Express Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternative should be done only during steady-state times (when blocd glucose level is not changing rapidly).
The On Callo Express Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only.
The On Call® Express Blood Glucose Monitoring System in not intended for the diagnosis of or diabetes, nor intended for use on neonates. The On Call® Express Blood Glucose Test Strips are used with the On Call Express Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm.
The On Call® Express Blood Glucose Control Solutions are for use with the On Call® Express Blood Glucose Meter and On Call® Express Blood Glucose Test Strips to check that the meter and test strips are working together properly and the test is performing correctly.
The On Call Express Blood Glucose Monitoring System is a quantitative assay for the detection of glucose in capillary whole blood sampled from the fingertip, palm and forearm. The glucose measurement is achieved by using the amperometric detection method.
The test strip has a reagent system including glucose oxidase and a mediator that reacts with glucose in the whole blood sample to produce an electrical current. This current is measured by the meter, and after calculation by the meter, the blood glucose concentration reading is displayed on the meter display, calibrated to a plasma reference.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the On Call Express Blood Glucose Monitoring System are based on the EN ISO 15197:2003 standard. The document states that the device "meets the accuracy requirements per EN ISO 15197:2003." Unfortunately, the specific numerical acceptance criteria from EN ISO 15197:2003 and the exact corresponding reported device performance values (e.g., % of results within ±15% or ±20% of reference for specific glucose ranges) are not detailed within the provided text. The text only provides a list of performance characteristics tested.
Therefore, the table below will list the relevant performance characteristics mentioned as being evaluated against the ISO standard in the "Laboratory Testing" section, and indicate that the exact reported performance values are not provided, but that the device meets the ISO standard.
| Acceptance Criteria Category (from ISO 15197:2003) | Reported Device Performance (as stated in document) |
|---|---|
| Repeatability precision | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Intermediate precision | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Accuracy evaluation | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 (compared to YSI Model 2300 STAT PLUS) |
| User performance | Evaluated (lay persons obtained comparable readings to trained technicians); device meets accuracy requirements per EN ISO 15197:2003 |
| Linearity | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Interfering agents | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Altitude effect | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| System traceability | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Validation of calibration control materials | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Hematocrit effect | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Temperature effect evaluation (blood & control solution) | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Low battery effect evaluation | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Sample volume | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Humidity effect | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Simulated shipping studies (test strip & control solution) | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Accelerated Use Life (control & strip) | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| 65° Accelerated Stability (Strip & Control) | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Packaging, vibration, drop tests, temperature exposure, humidity exposure | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Control value assignment | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Virucidal, efficacy validation | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Meter cleaning and disinfection | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Meter testing | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Software validation testing | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
| Electromagnetic compatibility and electrical safety testing (per EN/IEC 61010-1 & 61010-2-101) | Evaluated; device meets accuracy requirements per EN ISO 15197:2003 |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the sample size (number of patients or measurements) for the clinical studies involving lay persons and trained laboratory technicians. It simply mentions "clinical studies were conducted with lay persons and trained laboratory technicians."
- Data Provenance: The document does not specify the country of origin for the data. The study involved "lay persons" and "trained technicians" using the device. It is a prospective study as it involved conducting clinical studies and laboratory testing for the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: One "expert" device was used: the YSI Model 2300 STAT PLUS. The document does not specify a number of human experts involved in establishing the ground truth, but rather refers to readings obtained by "trained technicians."
- Qualifications of Experts: The ground truth was established by comparing the On Call Express Blood Glucose Monitoring System's readings to those from the YSI Model 2300 STAT PLUS (K913806), which is a laboratory reference method. The text mentions that "trained technicians" were involved in obtaining readings, implying they are qualified to operate such equipment and conduct these tests accurately. There is no mention of specific medical qualifications (e.g., radiologist with X years of experience) as this is a blood glucose monitoring device.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method in the traditional sense (e.g., 2+1, 3+1 consensus). Instead, the method involved direct comparison of the test device's readings with a recognized laboratory reference method (YSI Model 2300 STAT PLUS). The goal was to establish accuracy by demonstrating concordance, not to resolve discrepancies between multiple human readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. This type of study typically involves assessing the performance of multiple human readers on multiple cases, often with and without AI assistance. The study described focuses on the accuracy of the device itself and its usability by lay persons compared to trained technicians using a reference method. It does not evaluate human reader improvement with AI assistance. The device itself is a standalone glucose monitor, not an AI assistant to human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was conducted. The "Laboratory Testing" section lists numerous tests (repeatability, precision, accuracy, linearity, interfering agents, etc.) that evaluate the system's performance independently. The "clinical studies" also assess the device's ability to provide accurate blood glucose readings on its own, with lay persons simply operating it according to instructions. The comparison to the YSI Model 2300 STAT PLUS explicitly assesses the algorithm's (and integrated system's) accuracy against a gold standard.
7. The Type of Ground Truth Used
The ground truth used was reference laboratory measurement. Specifically, the On Call Express Blood Glucose Monitoring System's results were compared to those obtained from the YSI Model 2300 STAT PLUS (K913806), which is a widely accepted laboratory reference instrument for glucose measurement.
8. The Sample Size for the Training Set
The document does not provide information regarding a specific training set or its sample size. This device is a blood glucose monitoring system, not a machine learning model that typically undergoes explicit "training" on a separate dataset in the way an AI diagnostic algorithm would. The development and calibration of such devices usually involve internal studies by the manufacturer, but the specific details of these are not disclosed as "training set" information in this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" is mentioned in the context of a machine learning model, this question is not directly applicable. For the device's internal calibration and development, it's highly probable that similar reference laboratory methods (like YSI) would have been used, but the document does not elaborate on this.
§ 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.