# K063232: Architect Intact PTH Reagents, Calibrators (a-F) and Controls (Low, Medium, High), Models 8K25-20, 8K25-25, 8K25-01

- Pathway: 510(k) (Traditional)
- Applicant: Biokit, S.A.
- Decided: Jun 19, 2007 after 237 days
- Product code: CEW (Radioimmunoassay, Parathyroid Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1545
- Recalls of this device: 4 (0 Class I)
- 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.
3 later devices descend from it; 1 cites it directly.
0 of 6 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 2.

## Most influential descendants
- K121981: Advia Centaur Inact Parathyroid Hormone (Ipth) Assay (2013), 2 descendants of its own
- K133601: Advia Centaur Intact Parathyroid Hormone (Ipth) Assay (2014), 1 descendant of its own
- K163658: ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay (2017), 0 descendants of its own

## Recalls of this device
- Apr 9, 2019 · Class III · Z-1358-2019: Devices were delivered without the required dry ice.
- Apr 9, 2019 · Class III · Z-1357-2019: Devices were delivered without the required dry ice.
- Feb 12, 2014 · Class II · Z-1672-2014: Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples. Results generated with impacted lots may demo
- Feb 12, 2014 · Class II · Z-1671-2014: Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient samples. Results generated with impacted lots may demo

## Indications for use
The ARCHITECT Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System. The ARCHITECT Intact PTH assay is intended to be used as an aid in the differential diagnosis of hpyercalcemia, hypocalcemia and parathyroid disorders. The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of intact PTH in human serum and plasma. The ARCHITECT Intact PTH Controls are for the use in quality control to monitor the accuracy and precision of the ARCHITECT Intact PTH assay on the ARCHITECT i System for human serum and plasma.

Source page: https://510kreport.com/device/K063232
Methodology: https://510kreport.com/methodology