# K033727: Nichols Advantage Bio-Intact PTH (1-84) Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Nichols Institute Diagnostics
- Decided: Apr 22, 2004 after 146 days
- Product code: CEW (Radioimmunoassay, Parathyroid Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1545
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Apr 7, 2005 · Not classified · Z-0810-05: Values do not agree with Directional Instructions.

## Indications for use
The Nichols Advantage® Bio-Intact PTH (1-84) Immunoassay is intended for use with the Nichols Advantage® Specialty System to measure the levels of parathyroid hormone in serum, EDTA plasma and heparinized 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. Measurements of parathyroid hormone levels with the Bio-Intact PTH (1-84) Immunoassay are also used as an aid in monitoring therapeutic intervention of secondary hyperparathyroidism that frequently occurs in chronic kidney disease. 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/K033727
Methodology: https://510kreport.com/methodology