# K033063: Mission Controls

- Pathway: 510(k) (Traditional)
- Applicant: Diamond Diagnostics, Inc.
- Decided: Dec 12, 2003 after 74 days
- Product code: JJS (Controls For Blood-Gases, (Assayed And Unassayed))
- 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
Longest line of descent: 1 generation back to K950902 (1995). 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)
- K950902: Alko Tonometered Saline Control, Alko Diagnostic Corp. (1995) Summary page 1.

## Indications for use
There are 4 levels of QC encompassed in this request. Levels 1,2,3 cover the Low Mid High of the clinical range for the analytes included in the QC. Level 4 is to check at High O2 level. Mission Controls are intended for six systems: AVL Scientific: 990, 995; 982,983,985; 984, 987; 9110,9140; 9180, 9181 Ciba-Corning/Bayer: 248; 278; 288; 614,644; 654; 800 series IL: BG3; 1610,1620 NOVA: Stat Profile 1-5 Radiometer: ABL 300, 330; ABL, 50, 500, 520; BL 600, 610, 1620; EML-10 Medica, Shappare'li, Medarmin The products encompassed by this request are intended for in-vitro diagnostics use and are intended for pH/Blood Gas - (pH, pCO2, pO2), and Electrolyte - (Na, K, Cl, Ca, Li, TCO2) Analyzers to estimate test imprecision and to detect systematic deviations that may occur because of instrument or reagent variation. The products encompassed are to be handled using normal laboratory precautions.

Source page: https://510kreport.com/device/K033063
Methodology: https://510kreport.com/methodology