# K062674: Mission Trinity B

- Pathway: 510(k) (Traditional)
- Applicant: Diamond Diagnostics, Inc.
- Decided: Dec 1, 2006 after 84 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bayer Rapid Complete Level 1: named in the summary without a submission number
- (no number) Bayer Rapid Complete Level 2: named in the summary without a submission number
- (no number) Bayer Rapid Complete Level 3: named in the summary without a submission number

## Indications for use
Mission Trinity BTM Controls are intended to be used as a quality control material for monitoring the performance of pH, pCO2, pO2, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, %O2Hb, %COHb, %metHb & %HHb on Bayer instrumentation.

Source page: https://510kreport.com/device/K062674
Methodology: https://510kreport.com/methodology