# K163053: Lumipulse G E2-III Calibrators

- Pathway: 510(k) (Abbreviated)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: Dec 1, 2016 after 30 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 K965109 (1997). 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)
- K142021: Elecsys Estradiol III CalSet, Roche Diagnostics (2014) Summary page 4.

## Indications for use
Lumipulse * E2-III Calibrators are for in vitro diagnostic use in the calibration of Lumipulse * E2-III on the LUMIPULSE® * System.

Source page: https://510kreport.com/device/K163053
Methodology: https://510kreport.com/methodology