# K001427: Modification to Fasttake Compact Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Selfcare, Inc.
- Decided: Jun 2, 2000 after 28 days
- Product code: CGA (Glucose Oxidase, Glucose)
- 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
No predicates in its family tree.
14 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K060706: Liberty Normal Glucose Control Solution (2006), 8 descendants of its own
- K012324: Accu-Chek Active Test System (2001), 7 descendants of its own
- K070506: SMS Multi Glucose Control, Model 2120049 (2007), 5 descendants of its own
- K081403: Glucose Meter-Check Control Solution for Roche Accu-Chek (2008), 2 descendants of its own
- K021448: Modification to Accu-Chek Active System (2002), 2 descendants of its own

Source page: https://510kreport.com/device/K001427
Methodology: https://510kreport.com/methodology