# K133003: Rightest Control Solution

- Pathway: 510(k) (Traditional)
- Applicant: Bionime Corporation
- Decided: Oct 24, 2013 after 29 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: 6 generations back to K024194 (2003). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110737: Rightest Blood Glucose Monitoring System GM700, Bionime Corporation (2012) Summary page 2.

## Indications for use
The Rightest Control Solutions GC300 are for use with the Rightest Blood Glucose Meter GM300 and the Rightest Blood Glucose Test Strip GS300 to check that the meter and test strips are working together properly and that the test is performing correctly. The Rightest Control Solutions GC1 00 are for use with the Rightest Blood Glucose Meter GM100 and the Rightest Blood Glucose Test Strip GS1 00 to check that the meter and test strips are working together properly and that the test is performing correctly. The Rightest Control Solutions GC1 10 are for use with the Rightest Blood Glucose Meter GM1 10 and the Rightest Blood Glucose Test Strip GS300 to check that the meter and test strips are working together properly and that the test is performing correctly. The Rightest Control Solutions GC310 are for use with the Rightest Blood Glucose Meter GM31 0 and the Rightest Blood Glucose Test Strip GS31 0 to check that the meter and test strips are working together properly and that the test is performing correctly.

Source page: https://510kreport.com/device/K133003
Methodology: https://510kreport.com/methodology