# K030616: Cedia Cyclosporine Plus High Range Controls 4 and 5

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Mar 31, 2003 after 33 days
- Product code: LAS (Drug Specific Control Materials)
- Device class: 1
- Regulation: 21 CFR 862.3280
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K032842: Microgenics Cyclosporine Control Kit (2003), 0 descendants of its own

## Indications for use
The CEDIA@Cyclosporine Plus High Range Controls 4 and 5 are in-vitro diagnostic medical devices intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine.

Source page: https://510kreport.com/device/K030616
Methodology: https://510kreport.com/methodology