(192 days)
The TD-4140 Smart Dongle Blood Glucose plus [-ketone Monitoring System consists of the Smart Dongle blood glucose test strips, Smart Dongle {}-ketone test strips, and the Procheck mobile application as the display component of the system. This system is intended to be used for the quantitative measurement of glucose (sugar) and fketone in fresh capillary whole blood from the finger.
This system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is intended to be used by a single person and should not be shared. This system should not be used for the diagnosis of or screening for diabetes, nor for use on neonates.
The TD-4140 Smart Dongle Blood Glucose plus ß-ketone Monitoring System consists of the Smart Dongle meter, Smart Dongle blood glucose test strips, Smart Dongle 0-ketone test strips, and the Procheck mobile application as the display component of the system.
This system is compatible to iPhone series, including iPhone 4/4s, 5/5s, 6/6 plus, and iPod touch 5. These products have been designed, tested, and proven to work together as a system to produce accurate test results. The Smart Dongle meter should only be used with the Smart Dongle Blood Glucose test strips and the Smart Dongle ß-ketone test strips.
The provided text describes the TD-4140 Smart Dongle Blood Glucose plus ß-ketone Monitoring System, but only offers limited information on specific acceptance criteria for blood glucose and ß-ketone measurements. It reports accuracy and precision performance. The study described is a submission for 510(k) clearance, which typically involves demonstrating substantial equivalence to a predicate device through various performance characteristics, not necessarily a comparative effectiveness study with human readers.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state "acceptance criteria" but rather presents performance results against implicit standards for glucose and ß-ketone meters. The ranges below are derived from the reported accuracy tables for blood glucose and ß-ketone.
| Measurement Parameter | Acceptance Criteria (Implied from Performance Tables) | Reported Device Performance |
|---|---|---|
| Blood Glucose | ||
| Accuracy: | For glucose |
§ 862.1435 Ketones (nonquantitative) test system.
(a)
Identification. A ketones (nonquantitative) test system is a device intended to identify ketones in urine and other body fluids. Identification of ketones is used in the diagnosis and treatment of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets and patients with diabetes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.