(78 days)
The CareSens N Meter is used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management at home or in clinical settings. CareSens N Blood Glucose System should be used only for testing outside the body (in vitro diagnostic use only). Do not use the system for the diagnosis or screening of diabetes. Testing sites include the traditional fingertip testing along with alternate sites testing on forearm, palm, thigh and calf.
CareSens N Test Strip is used with the CareSens N Blood Glucose Meter for quantitatively measuring glucose in capillary whole blood. The CareSens N Test Strip is intended for selftesting outside the body (in vitro diagnostic use only). Do not use the system for the diagnosis of diabetes without the guidance of healthcare professional. Testing sites include the traditional fingertip testing along with alternate sites testing on forearm, palm, thigh and calf.
CareSens Control A&B Solutions are a red liquid to check that both the meters and test strips are working together properly. It contains a known range of glucose as written on the bottle.
CareSens N Blood Glucose Monitoring System ("CareSens N BGMS") is an in vitro diagnostic device designed to measure the concentration of glucose in capillary whole blood with CareSens N Test Strips. The CareSens N model consists of the CareSens N meter (Model GM505IA, GM505IB, GM505IC: IA, IB and IC indicates the color of the devices, respectively, black, white, and light blue.), CareSens N test strips, and CareSens control solutions for two different glucose concentration ranges (called "Normal" and "Middle" ranges), lancing device, lancets, user manual, quick reference guide and a logbook.
The provided document describes the CareSens N Blood Glucose Monitoring System, a modification of the previously cleared CareSens Blood Glucose Monitoring System. The modifications include automatic code identification, alarms, and post-meal flagging. The document presents performance evaluation summaries for both the original and modified features.
1. A table of acceptance criteria and the reported device performance
| Test | Pre-determined Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Evaluation (Original Features) | ||
| PE-01 Repeatability Test |
§ 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.