# K063605: ST Aia-Pack Intact PTH Assay

- Pathway: 510(k) (Traditional)
- Applicant: Tosoh Bioscience, Inc.
- Decided: Jun 21, 2007 after 199 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: 2 generations back to K954418 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992680: Elecsys Parathyroid Hormone Test System, Roche Diagnostics Corp. (1999) Summary page 1.

## Indications for use
ST AIA-PACK Intact PTH is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of the levels of parathyroid hormone in human serum and EDTA plasma on specific TOSOH AIA System analyzers. 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. The ST AIA-PACK Intact PTH CALIBRTOR SET is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK Intact PTH. The AIA-PACK Intact PTH CONTROL SET is intended for IN VITRO DIAGNOSTIC USE ONLY for performing quality control procedures with the ST AIA-PACK Intact PTH Assay.

Source page: https://510kreport.com/device/K063605
Methodology: https://510kreport.com/methodology