# K971276: Glucometer Encore QA+ Blood Glucose Meter

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Jun 16, 1997 after 70 days
- Product code: CFR (Hexokinase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) GLUCOMETER ENCORE® Blood Glucose Monitoring System: named in the summary without a submission number
- (no number) ACCU-CHEK® ADVANTAGE® Blood Glucose System: named in the summary without a submission number
- (no number) YSI Blood Glucose Analyzer: named in the summary without a submission number

## Indications for use
The GLUCOMETER ENCORE QA+ Blood Glucose Monitoring System is an over-the-counter (OTC) home test for glucose in blood. The system is for use by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes. The GLUCOMETER ENCORE QA+ Blood Glucose Monitoring System can be used with capillary and venous blood specimens, arterial blood specimens and neonatal blood specimens.

Source page: https://510kreport.com/device/K971276
Methodology: https://510kreport.com/methodology