scope:

This guideline provides instructions and recommendations concerning the administration of point-of-care (POC) blood glucose monitoring programs at acute and chronic care facilities where laboratory support is available. POC blood glucose meter systems provide rapid results required by medical staff members to make therapeutic decisions.

This document applies to quantitative in vitro POC blood glucose meter systems intended for use by health care professionals for management of patients with diabetes mellitus and other conditions with fluctuations in glucose homeostasis. These test systems may be indicated for use with arterial, venous, or capillary whole blood samples obtained from adults, children, or neonates. This guideline does not pertain to glucose measurement for the purpose of self-monitoring of blood glucose, screening for diabetes, or diagnosing diabetes mellitus or other disorders of glucose metabolism.

As criteria for accepting a POC glucose meter are included in this document, manufacturers may wish to refer to this document as an indication of clinical requirements in the marketplace.

Automated clinical laboratory systems or analyzers used to perform routine and stat glucose testing on plasma, serum, whole blood, urine, and cerebrospinal fluid are not included in the scope of this guideline.