# K041478: BD Logic Blood Glucose Monitor and Paradigm Link Blood Glucose Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson
- Decided: Oct 28, 2004 after 147 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 2 (0 Class I)
- 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) BD Logic Blood Glucose Monitor: named in the summary without a submission number
- (no number) Paradigm Link Blood Glucose Monitor: named in the summary without a submission number
- (no number) Bayer Glucometer Dex: named in the summary without a submission number
- (no number) TheraSense FreeStyle: named in the summary without a submission number

## Recalls of this device
- Jan 5, 2006 · Not classified · Z-0560-06: BD Blood Glucose Monitors may inadvertently switch the Unit of Measure from mg/dL to mmol/L or vice versa during battery insertion or when a meter is dropped.
- Jan 5, 2006 · Not classified · Z-0562-06: BD Blood Glucose Monitors may inadvertently switch the Unit of Measure from mg/dL to mmol/L or vice versa during battery insertion or when a meter is dropped.

## Indications for use
BD Logic and Paradigm Link Blood Glucose Monitors are intended to be used for the quantitative measurement of glucose in whole blood. The monitors are intended for use by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. BD monitors are not intended for use in the diagnosis of or screening for diabetes mellitus and are not intended for use on neonates. BD Logic and Paradigm Link Blood Glucose Monitors are specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the fingertip, palm, and forearm.

Source page: https://510kreport.com/device/K041478
Methodology: https://510kreport.com/methodology