# K093384: Mission Trinity R (Level 1) (Level 2) (Level 3), (Level 1,2,3)

- Pathway: 510(k) (Traditional)
- Applicant: Diamond Diagnostics, Inc.
- Decided: Mar 10, 2010 after 131 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K880447 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K880447: Multi-Function Blood Gas Control, Bionostics, Inc. (1988) Summary page 2.

## Recalls of this device
- Feb 13, 2019 · Class II · Z-1057-2019: An error in the assignment of the control range pH in Blood Gas Control

## Indications for use
Mission Trinity R Control is intended to be used as an assayed quality control material for monitoring the precision and performance of the following analytes pH, pCO2, PO2, Na+, K, Ca+, Cl, glucose, and lactate on blood gas, electrolyte, and metabolite analyzers as well as tHb, %O2Hb, %O2Sat, %COHb, %MetHb, %O2Ct & %HHb on CO-Oximeter instrumentation.

Source page: https://510kreport.com/device/K093384
Methodology: https://510kreport.com/methodology