(220 days)
FORA Diamond Prima Blood Glucose Monitoring System is Intended for self testing outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The system is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. This system is intended for single-patient use and should not be shared. The FORA Diamond Prima Blood Glucose Test Strips are for use with the FORA Diamond Prima Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
FORA Diamond Mini Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The system is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitys. and is not intended for use on neonates. This system is intended for single-patient use and should not be shared. The FORA Diamond Mini Blood Glucose Test Strips are for use with the FORA Diamond Mini Blood Clucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only FORA test strips and FORA control solutions (cleared under K093724) with the FORA Diamond Prima Blood Glucose Monitoring System and FORA Diamond Mini Blood Glucosc Monitoring System.
This 510(k) summary describes the "FORA Diamond Prima Blood Glucose Monitoring System" and "FORA Diamond Mini Blood Glucose Monitoring System." The information regarding acceptance criteria and study details is limited as it relies heavily on substantial equivalence to a predicate device (TD-4277, K100322) rather than presenting new detailed performance studies.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state specific numerical acceptance criteria for accuracy (e.g., ISO 15197 standards). Instead, it relies on the assertion of substantial equivalence to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (TD-4277, K100322) in performance characteristics | "A comparison of system accuracy performance demonstrated that the FORA Diamond Prima Blood Glucose Monitoring System, FORA Diamond Mini Blood Glucose Monitoring System and the TD-4277 blood glucose monitoring system are substantially equivalent." |
| Performance, safety, and effectiveness equivalent to the predicate device | "Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA Diamond Prima Blood Glucose Monitoring System and FORA Diamond Mini Blood Glucose Monitoring System are equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "A comparison of system accuracy performance" without providing details.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided. Given that it's a blood glucose monitoring system, the "ground truth" would typically refer to a laboratory reference method (e.g., YSI analyzer) rather than expert human interpretation.
4. Adjudication Method for the Test Set:
Not applicable or not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This type of study is relevant for imaging or diagnostic devices where human readers interpret results, comparing aided vs. unaided performance. For a blood glucose meter, the output is a numerical value.
6. Standalone (Algorithm Only) Performance:
The entire system (meter, test strips, control solutions) is presented as a standalone device for measuring glucose. However, the document does not present separate "algorithm only" performance data distinct from the overall system performance. The "algorithm" is embedded within the meter's software. The study essentially demonstrates the standalone performance of the device (meter + strip) as it is intended to be used.
7. Type of Ground Truth Used:
The document implicitly refers to a "comparison of system accuracy performance" against the predicate device. For blood glucose meters, the ground truth is typically established using a highly accurate laboratory reference method, such as a YSI glucose analyzer. While not explicitly stated, this is the standard for such devices.
8. Sample Size for the Training Set:
The document does not specify a training set sample size. This is common for predicate-based submissions where the original predicate device's data or established engineering principles are relied upon. Any "software modification" mentioned would have its own internal testing, but details are not provided.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided. If a training set was used for software development, the ground truth would likely have been established through a reference method (e.g., YSI analyzer). However, the document focuses on the end-product's equivalence to a predicate.
§ 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.