# K092993: Advia Centaur Cyclosporine Master Curve Material

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Nov 20, 2009 after 53 days
- Product code: JJX (Single (Specified) Analyte Controls (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: 3 generations back to K950469 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062501: Validate Thyroid Calibration Verification / Linearity Test Set, Model 901, Maine Standards Co. (2006) Summary page 4.

## Indications for use
The ADVIA Centaur® Cyclosporine Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range in the ADVIA Centaur® Cyclosporine (CsA) assay.

Source page: https://510kreport.com/device/K092993
Methodology: https://510kreport.com/methodology