# K133751: Diamond Diagnostics Ise Serum Standards, Diamond Diagnostics Ise Urine Standards

- Pathway: 510(k) (Traditional)
- Applicant: Diamond Diagnostics, Inc.
- Decided: Aug 8, 2014 after 242 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 K945271 (1995). 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)
- K121027: Diamond Calibrator Low, Diamond Calibrator High, Diamond Diagnostics, Inc. (2012) Summary page 5.

## Indications for use
Diamond Diagnostics ISE Serum Standards are intended for in-vitro diagnostics to provide calibration points for the sodium, potassium, and chloride electrodes on ADVIA Chemistry systems in Human Serum mode. Diamond Diagnostics ISE Urine Standards are intended for in-vitro diagnostics to provide calibration points for the sodium, potassium, and chloride electrodes on ADVIA Chemistry systems in Human Urine mode.

Source page: https://510kreport.com/device/K133751
Methodology: https://510kreport.com/methodology