# K100398: Smartlink Gold Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Standard Diagnostics, Inc.
- Decided: Jun 9, 2010 after 113 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: 2 generations back to K024194 (2003). 3 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082683: SD Check Gold, Standard Diagnostics, Inc. (2009) Summary page 2.

## Most influential descendants
- K132929: SD Gluconavii Mentor NFC Multi Blood Glucose Monitoring System, and SD Gluconavii Mentor NFC Blood Glucose Monitoring System (2015), 1 descendant of its own
- K123517: Glucomentor Blood Glucose Monitoring System, Glucomentor Multi Blood Glucose Monitoring System (2014), 1 descendant of its own
- K160282: SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System (2017), 0 descendants of its own
- K153201: SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System (2016), 0 descendants of its own
- K151265: SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System (2015), 0 descendants of its own

## Indications for use
SmartLinkTm GOLD blood glucose monitoring system is indicated for monitoring glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm. SmartLink TM GOLD meter must be used with SmartLink'T m GOLD blood glucose test strip and SD Control solutions. The SD control solutions Level M and Level H are for use with SmartLink Tm GOLD test system as quality controls to verify the accuracy of blood glucose test results. Testing is done outside the body (in vitro diagnostic use). This system is indicated for home (over-the-counter, OTC) by person with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. This system should not be used for the screening or diagnosis of diabetes or for testing neonates.

Source page: https://510kreport.com/device/K100398
Methodology: https://510kreport.com/methodology