# K062187: Betachek Glucose Test

- Pathway: 510(k) (Traditional)
- Applicant: National Diagnostic Products
- Decided: Mar 24, 2009 after 966 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- 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
Longest line of descent: 1 generation back to K943503 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943503: Chemcard Glucose Test, Chem-Elec, Inc. (1996) Summary page 1.

## Indications for use
Betachek Blood Glucose (Sugar) is a test intended to be used by non-diabetic individuals at home to estimate their fasting blood glucose (blood sugar) level from a drop of blood obtained from a finger stick. Any abnormal results should be verified by a medical professional, such as a physician, and confirmed with a quantitative, laboratory reference method. Only a trained medical professional can determine if an individual has diabetes. A test result within the normal range does not exclude the possibility that the individual has diabetes or pre-diabetes. Any individual who is concerned that he or she may have diabetes or pre-diabetes should seek the advice of a physician. Betachek Blood Glucose Test is not intended to be used for children or by individuals who are diabetic or pregnant. This test can not be used to screen or diagnose diabetes. It should not be used for children or by individuals who are diabetic or pregnant. This test is only intended for individual use at home. It is not for use as part of a screening program in a healthcare setting or any other setting.

Source page: https://510kreport.com/device/K062187
Methodology: https://510kreport.com/methodology