# K040813: Nichols Advantage Chemiluminescence Intact Parathyroid Hormone, Model 62-7022

- Pathway: 510(k) (Traditional)
- Applicant: Nichols Institute Diagnostics
- Decided: Jun 8, 2004 after 70 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 K962598 (1996). 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)
- K962598: Nichols Advantage Chemiluminescence Intact Parathyroid Hormone Kit, Nichols Institute Diagnostics (1996) Summary page 1.

## Indications for use
The Nichols Advantage® Chemiluminescence Intact Parathyroid Hormone Immunoassay is intended for use with the Nichols Advantage® Specialty System for the quantitative determination of intact parathyroid hormone in human EDTA plasma, heparinized plasma and serum. 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 intact parathyroid hormone levels 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/K040813
Methodology: https://510kreport.com/methodology