# K050125: Rap/Tac/Csa Control - Level 1,2,3,4

- Pathway: 510(k) (Traditional)
- Applicant: More Diagnostics
- Decided: Mar 18, 2005 after 58 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The use of control material to estimate test precision in a test system and to detect systematic deviation that may arise from reagent or analytical instrurnent variation in the measurement of cyclosporine A, tacrolimus and rapamycin.

Source page: https://510kreport.com/device/K050125
Methodology: https://510kreport.com/methodology