# K082965: DS-a Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Alliance International Co., Ltd.
- Decided: Dec 7, 2009 after 430 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
Longest line of descent: 2 generations back to K010362 (2001). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043474: Accu-Chek Aviva System, Roche Diagnostics Corp. (2005) Summary page 1.

## Most influential descendants
- K132663: I-Qare DS-W Blood Glucose Monitoring System (2015), 0 descendants of its own

## Indications for use
The A-CHECK DS-A Blood Glucose Monitoring System is used with DS-A Test Strips and 3-level Controls for the measurement of glucose in fresh capillary whole blood from the finger. Testing is done outside the body ( in vitro diagnostic use). It is indicated for use at home ( over the counter [OTC] ) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness, of diabetes control. These are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates. The DS-A Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. DS-A Test Strips must be used with the A-CHECK DS-A Blood Glucose Monitoring System. 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. These are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates. The Alliance Blood Glucose 3 levels Control Solution are for use with the A-CHECK DS-A Blood Glucose Monitoring System and DS-A Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Source page: https://510kreport.com/device/K082965
Methodology: https://510kreport.com/methodology