# K120591: Diamond Tokyo Boeki Ise Module Calibrator 1,2,1-2

- Pathway: 510(k) (Traditional)
- Applicant: Diamond Diagnostics, Inc.
- Decided: Apr 17, 2012 after 49 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 K851172 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040958: Prestige Models 24I and 400 and MGC Model 240, Tokyo Boeki Medical System, Ltd. (2005) Summary page 3.

## Indications for use
Diamond Calibrators for Tokyo Boeki ISE Modules are intended for in-vitro diagnostics use to provide calibration points for the Na+, K+, and Cl-electrodes on the Tokyo Boeki Prestige 24i, Biolis 24i, MGC 240, and Sirrus instruments in both Human Serum and Human Urine modes.

Source page: https://510kreport.com/device/K120591
Methodology: https://510kreport.com/methodology