# K073416: Arkray Glucocard 01 Blood Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Arkray Factory USA, Inc.
- Decided: Jun 13, 2008 after 193 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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) Advance Micro-draw BGM: named in the summary without a submission number

## Most influential descendants
- K124021: Arkray Glucocard 01 Blood Glucose Monitoring System and Relion Confirm Blood Glucose Monitoring System (2014), 1 descendant of its own
- K142336: GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System (2014), 0 descendants of its own

## Indications for use
The GLUCOCARDTM 01 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 [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. The GLUCOCARDTM 01 Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. GLUCOCARDTM 01 SENSOR Blood Glucose Test Strips must be used with the GLUCOCARDTM 01 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. GLUCOCARDTM 01 SENSOR Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. GLUCOCARDTM 01 SENSOR Blood Glucose Test Strips must be used with the GLUCOCARDTM 01 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. (JLU(OCARIJ'M U1 CONTROL: For use with GLUCOCARDTM 01 Blood Glucose Meter and GLUCOCARDTM 01 SENSOR Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. Control solutions are available in three levels - Low (L), Normal (N) and High (H).

Source page: https://510kreport.com/device/K073416
Methodology: https://510kreport.com/methodology