# K110571: Telcare Blood Glucose Monitoring System, Test Strips, Control Solutions, Telserve-Home Use, Telserve-Professional Use

- Pathway: 510(k) (Traditional)
- Applicant: Telcare, Inc.
- Decided: Jul 28, 2011 after 149 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011233 (2001). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102037: Autosure Voice II Blood Glucose Monitoring System and Test Strips, Apex BioTechnology Corp. (2010) Summary page 1.
- K073699: MCT-Diabetes, Mycare Team, Inc. (2008) Summary page 1.
- K062799: Gluco Track Blood Glucose Monitoring System, Apex BioTechnology Corp. (2007) Summary page 1.

## Most influential descendants
- K120064: Test, Blood Glucose System (2012), 1 descendant of its own
- K131173: FIA Blood Glucose Monitoring System (G2) (2014), 0 descendants of its own

## Recalls of this device
- Jan 30, 2025 · Class II · Z-1270-2025: Telcare, LLC has received customer complaints related to battery expansion/swelling for its Philips Connected Blood Glucose Meter (i.e., BGM 4 brand name) Monitoring System.. The issue was identified 

## Indications for use
Telcare Blood Glucose Monitoring System The Telcare Blood Glucose Monitoring system is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended for lay use by persons with diabetes to aid in diabetes management. It is indicated for use at home (over the counter [OTC]) and should be used only by a single patient and should not be shared. Testing is done outside the body (in vitro diagnostic use). The Telcare Blood Glucose Monitoring System consists of the Telcare Blood Glucose Meter, Telcare Blood Glucose Test Strips, and Telcare Glucose Control Solutions. The Telcare Blood Glucose Monitoring system is not indicated for the diagnosis or screening of diabetes or for neonatal use. Palm and forearm testing should be done only during steady-state times when glucose is not changing rapidly. The Telcare Blood Glucose Meter uses cellular data transmission to send test results to Telcare's remote database,Telserve, and to receive messages from Telserve. The Telcare Blood Glucose Monitoring System is not intended to provide automated treatment guidance or decisions, nor is it to be used as a substitute for professional healthcare judgment. Telcare Blood Glucose Test Strips The Telcare Blood Glucose Test Strips are to be used with the Telcare Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, palm, or forearm. These test strips are intended for lay use by persons with diabetes and should only be used by a single patient. They are not indicated for the diagnosis or screening of diabetes or for neonatal use. Palm and forearm testing should be done only during steady-state times when glucose is not changing rapidly. Telcare Glucose Control Solutions The purpose of the control solution is to validate the performance of the Telcare Blood Glucose Monitoring System by using a test solution with a known amount of glucose. A control test that falls within the acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly. Telserve Data Management System - Home Use The Telserve Data Management System - Home Use (Telserve - Home) is an accessory to blood glucose monitoring systems for the review and evaluation of blood glucose test results to aid in diabetes management. Telserve collects data from blood glucose meters such as the Telcare BGM. Telserve - Home is not intended to provide automated treatment guidance or decisions, nor is it to be used as a substitute for professional healthcare judgment. Telserve Data Management System - Professional Use The Telserve Data Management System - Professional Use (Telserve - Pro) is an accessory to blood glucose monitoring systems for the review and evaluation of blood glucose test results to aid in diabetes management. Telserve collects data from blood glucose meters such as the Telcare BGM.

Source page: https://510kreport.com/device/K110571
Methodology: https://510kreport.com/methodology