# K132663: I-Qare DS-W Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Alliance International Co., Ltd.
- Decided: Apr 20, 2015 after 602 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- 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: 3 generations back to K010362 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082965: DS-a Blood Glucose Monitoring System, Alliance International Co., Ltd. (2009) Summary page 4.

## Indications for use
The i-QARE DS-W Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The i-QARE DS-W Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The i-QARE DS-W Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The i-QARE DS-W Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The i-QARE DS-W Draw-in Blood Glucose Test Strips are for use with the i-QARE DS-W Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

Source page: https://510kreport.com/device/K132663
Methodology: https://510kreport.com/methodology