# K033302: Nichols Advantage Bio-Intact PTH (1-84) Assay, Model 62-7040

- Pathway: 510(k) (Special)
- Applicant: Nichols Institute Diagnostics
- Decided: Jan 26, 2004 after 104 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: 1 generation back to K013992 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013992: Nichols Advantage Chemiluminescence Bio-Intact Parathyroid Hormone (1-84) Immunoassay, Nichols Institute Diagnostics (2001) Summary page 1.

## 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/K033302
Methodology: https://510kreport.com/methodology