# K001411: Whole PTH (1-84) Specific Immunoradiometric Irma Diagnostic Assay Kit, Model 3KG056

- Pathway: 510(k) (Traditional)
- Applicant: Scantibodies Laboratory, Inc.
- Decided: Aug 21, 2000 after 109 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K150879: LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers (2015), 1 descendant of its own
- K190702: Lumipulse G whole PTH (2019), 0 descendants of its own

Source page: https://510kreport.com/device/K001411
Methodology: https://510kreport.com/methodology