# K022580: Bacton Dickinson Latitude Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Oct 9, 2002 after 65 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 3 (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) Glucometer DEX Test Sensor: named in the summary without a submission number

## Recalls of this device
- Jan 5, 2006 · Not classified · Z-0561-06: 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 29, 2004 · Not classified · Z-0763-04: 39 lots of BD Test strip may produce an increased frequency of E-3 messages when used during blood glucose testing.
- Jul 23, 2003 · Not classified · Z-1221-03: Test Strips may not be meeting specifications at the lower range of glucose values.

## Indications for use
The Becton Dickinson LatitudeTMDiabetes Management System is intended to be used for the quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellitus in the home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The Becton Dickinson LatitudeTMDiabetes Management System is specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the fingertip.

Source page: https://510kreport.com/device/K022580
Methodology: https://510kreport.com/methodology