# K070506: SMS Multi Glucose Control, Model 2120049

- Pathway: 510(k) (Traditional)
- Applicant: Medical Specialties Supply Co., Inc.
- Decided: Apr 18, 2007 after 56 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K945887 (1995). 16 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011479: One Touch Fasttake Compact Blood Glucose Monitoring System, One Touch Ultra Blood Glucose Monitoring System, Inverness Medical Innovations, Inc. (2001) Summary page 1.
- K011738: Accu-Chek Active System, Roche Diagnostics Corp. (2001) Summary page 2.
- K060706: Liberty Normal Glucose Control Solution, Liberty Healthcare Group, Inc. (2006) Summary page 2.

## Cited in the summary but kept off the family tree
- K023657: Ascensia Microfill Control Solution. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K081403: Glucose Meter-Check Control Solution for Roche Accu-Chek (2008), 2 descendants of its own
- K123851: Glucose Meter-Check Solution for Roche Accu-Chek (2013), 1 descendant of its own
- K082395: Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter, Model: MC002 (2008), 1 descendant of its own
- K152493: POGO Automatic Blood Glucose Monitoring System (2016), 0 descendants of its own
- K123966: Glucose Meter-Check Solution for Bayer (2013), 0 descendants of its own

## Indications for use
For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the Roche Accu-chek Active, the Bayer Ascensia Contour, and the LifeScan OneTouch Ultra and FastTake Blood Glucose Monitors.

Source page: https://510kreport.com/device/K070506
Methodology: https://510kreport.com/methodology