# K013992: Nichols Advantage Chemiluminescence Bio-Intact Parathyroid Hormone (1-84) Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Nichols Institute Diagnostics
- Decided: Dec 13, 2001 after 9 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; 2 cite 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. The FDA summary names its predicate without a number.
- (no number) Nichols Intact PTH Immunoassay: named in the summary without a submission number

## Most influential descendants
- K033727: Nichols Advantage Bio-Intact PTH (1-84) Immunoassay (2004), 0 descendants of its own
- K033302: Nichols Advantage Bio-Intact PTH (1-84) Assay, Model 62-7040 (2004), 0 descendants of its own

## Indications for use
The Nichols Advantage® Bio-Intact PTH (1-84) immunometric assay is intended for use with the Nichols Advantage® Specialty System to measure the levels of parathyroid hormone in serum and EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.

Source page: https://510kreport.com/device/K013992
Methodology: https://510kreport.com/methodology