# K082683: SD Check Gold

- Pathway: 510(k) (Traditional)
- Applicant: Standard Diagnostics, Inc.
- Decided: Dec 8, 2009 after 449 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: 1 generation back to K024194 (2003). 2 ancestors in all.
6 later devices descend from it; 1 cites 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)
- K032552: Accu-Chek Advantage System, Roche Diagnostics Corp. (2003) Summary page 2.
- K024194: One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems, Lifescan, Inc. (2003) Summary page 2.

## Most influential descendants
- K100398: Smartlink Gold Blood Glucose Monitoring System (2010), 5 descendants of its own
- 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

## Indications for use
SD CHECK 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. SD CHECK GOLD meter must be used with SD CHECK GOLD blood glucose test strip and SD CHECK GOLD control solutions. The SD Check Gold control solutions Level M and Level H are for use with SD Check 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 newborns.

Source page: https://510kreport.com/device/K082683
Methodology: https://510kreport.com/methodology