# K142895: LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: May 21, 2015 after 230 days
- Product code: LTK (Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125))
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K983715 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020828: CA 125 Assay for the Advia Centaur System, Bayer Corp. (2002) Summary page 7.

## Indications for use
Lumipulse G CA125II Immunoreaction Cartridges For in vitro diagnostic use. Lumipulse G CA125II is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of CA125 in human serum and plasma (sodium heparin, lithium heparin, or dipotassium EDTA) on the LUMIPULSE G System. The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with ovarian cancer. Serial testing for patient CA125 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer. Lumipulse G CA125II Calibrators Lumipulse G CA125II Calibrators are for use in the calibration of the LUMIPULSE G System for the quantitative measurement of CA125 in human serum or plasma (sodium heparin, lithium heparin, or dipotassium EDTA). LUMIPULSE G1200 System LUMIPULSE G1200 is intended for in vitro diagnostics use, and is designed to perform automated chemiluminescence immunoassays of specimens using Lumipulse G reagents, conducting various processes such as dispensing, agitation and photometric measurement.

Source page: https://510kreport.com/device/K142895
Methodology: https://510kreport.com/methodology