# K121027: Diamond Calibrator Low, Diamond Calibrator High

- Pathway: 510(k) (Traditional)
- Applicant: Diamond Diagnostics, Inc.
- Decided: Dec 20, 2012 after 260 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: 1 generation back to K945271 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945271: Atac 8000 Random Access Chemistry System, Bio-Chem Laboratory Systems, Inc. (1995) Summary page 2.

## Most influential descendants
- K133751: Diamond Diagnostics Ise Serum Standards, Diamond Diagnostics Ise Urine Standards (2014), 0 descendants of its own

## Indications for use
Diamond Diagnostics Calibrators for ATAC 8000 and Envoy 500 instruments are intended to provide calibration points for the Nat, K+, Cl-' and CO 2 electrodes on the ATAC 8000 and Envoy 500 instruments.

Source page: https://510kreport.com/device/K121027
Methodology: https://510kreport.com/methodology