# K022472: Parathyroid Hormone Test System/Nichols Advantage Quick-Intraoperative Bio-Intact PTH (1-84)

- Pathway: 510(k) (Traditional)
- Applicant: Nichols Institute Diagnostics
- Decided: Oct 9, 2002 after 75 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Nichols Advantage Bio-Intact PTH (1-84): named in the summary without a submission number

## Indications for use
The Nichols Advantage QuiCk-IntraOperative'M Bio-Intact PTH (1-84) is intended for use with the Nichols Advantage@Specialty System to measure parathyroid hormone in EDTA plasma and human serum. This procedure is recommended for rapid intraoperative measurement of Intact PTH 1-84 using EDTA plasma or human serum. The reagent cartridge is designed for single use only.

Source page: https://510kreport.com/device/K022472
Methodology: https://510kreport.com/methodology