# K143639: IMMULITE 2000 CEA Calibration Verification Material

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Jan 23, 2015 after 32 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: 7 generations back to K950469 (1995). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140258: Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification Material, Siemens Healthcare Diagnostics, Inc. (2014) Summary page 4.

## Indications for use
The IMMULITE® CEA Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE CEA assay on the IMMULITE 2000 systems.

Source page: https://510kreport.com/device/K143639
Methodology: https://510kreport.com/methodology