# K190702: Lumipulse G whole PTH

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: Aug 30, 2019 after 165 days
- Product code: CEW (Radioimmunoassay, Parathyroid Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1545
- 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 K033426 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150879: LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers, DiaSorin, Inc. (2015) Summary page 6.

## Indications for use
For in vitro diagnostic use Lumipulse G whole PTH is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative measurement of PTH (1-84) in human serum and plasma on the LUMIPULSE G System. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism.

Source page: https://510kreport.com/device/K190702
Methodology: https://510kreport.com/methodology