# K954418: Intact Parathyroid Hormone (PTH) Immunoassay (Modification)

- Pathway: 510(k) (Traditional)
- Applicant: Nichols Institute Diagnostics
- Decided: Nov 3, 1995 after 42 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.
25 later devices descend from it; 2 cite it directly.
0 of 26 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
- K020217: Acs:180 and Advia Centaur Ipth Immunoassay (2002), 12 descendants of its own
- K992680: Elecsys Parathyroid Hormone Test System (1999), 11 descendants of its own
- K133124: Immulite 2000; Total T3 Calibration Verification Material, Total T4 Calibration Verification Material, Total TBG Calibra (2013), 5 descendants of its own
- K132515: Liaison N-Tact PTH Gen II, Control Set, Calibration Verifiers (2013), 4 descendants of its own
- K141463: Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration Verifiers (2014), 3 descendants of its own

Source page: https://510kreport.com/device/K954418
Methodology: https://510kreport.com/methodology