(92 days)
The EMV3.1 Pro Blood Glucose System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing is done outside the body (In Viro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. The system includes the speaking function but is not intended to be operated by visually impaired users.
The system consists of the EMV3.1 Pro meter and the EMV3.1 Pro test strips. The EMV3.1 Pro meter only is used with the EMV3.1 Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.
The EMV3.1 Glucose Control Solution For use with the EMV3.1 Pro Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results.
The EMV3.1 Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system includes the speaking function but is not intended to be operated by visually impaired users. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.
The system consists of the EMV3.1 meter and the EMV3.1 meter only is used with the EMV3.1 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.
The EMV3.1 Glucose Control Solution For use with EMV3.1 Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.
The system consists of the EMV3.1 Pro meter and the EMV3.1 Pro test strips. The EMV3.1 Pro meter only is used with the EMV3.1 Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip.
The system consists of the EMV3.1 meter and the EMV3.1 meter only is used with the EMV3.1 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.
The provided document is limited to the FDA 510(k) clearance letters and "Indications for Use" statements for the EMV3.1 Self Monitoring Blood Glucose System and EMV3.1 Pro Blood Glucose System.
It does not contain the detailed study information, acceptance criteria tables, or performance metrics that would be necessary to fully answer your request.
Therefore, I cannot provide the specific information regarding:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts and their qualifications for ground truth establishment
- Adjudication method
- MRMC comparative effectiveness study results (effect size)
- Standalone algorithm performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
What the document does tell us:
- Device Names: EMV3.1 Self Monitoring Blood Glucose System and EMV3.1 Pro Blood Glucose System.
- Purpose: Quantitative measurement of glucose in whole blood.
- Intended Use (EMV3.1 Pro): Professional healthcare settings, venous or fresh capillary whole blood, multiple-patient use, aid to monitor diabetes control. Not for neonates, diagnosis, or screening for diabetes. Not for visually impaired users to operate.
- Intended Use (EMV3.1 Self Monitoring): Home use (OTC), single patient, fresh capillary whole blood from fingertip, palm, or forearm, aid to monitor diabetes control. Not for neonates, diagnosis, or screening for diabetes. Not for visually impaired users to operate. Alternative site testing only during steady-state blood glucose conditions.
- Components: Meter and test strips.
- Control Solution: EMV3.1 Glucose Control Solution for quality control.
- Regulatory Classification: Class II, Product Codes NBW, LFR, JJX.
- 510(k) Number: K133647.
To answer your request, you would need to consult detailed study reports (e.g., from the 510(k) submission materials, if publicly available, or from peer-reviewed publications by the manufacturer).
§ 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.