# K082417: Glucocard 01-Mini Blood Glucose Monitoring System, Model 73110

- Pathway: 510(k) (Special)
- Applicant: Arkray Factory USA, Inc.
- Decided: Oct 21, 2008 after 60 days
- Product code: CGA (Glucose Oxidase, 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) ARKRAY GLUCOCARDTM 01 Blood Glucose Monitoring System: named in the summary without a submission number

## Most influential descendants
- K142035: Glucocard 01-Mini Blood Glucose Monitoring System, Relion Micro Blood Glucose Monitoring System (2014), 0 descendants of its own

## Indications for use
The GLUCOCARDTM 01-mini Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTO]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

Source page: https://510kreport.com/device/K082417
Methodology: https://510kreport.com/methodology