# K143075: ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set

- Pathway: 510(k) (Traditional)
- Applicant: Tosoh Bioscience, Inc.
- Decided: Jul 2, 2015 after 248 days
- Product code: CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone)
- Device class: 1
- Regulation: 21 CFR 862.1680
- 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: 3 generations back to K941797 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060818: Architect SHBG Reagent Kit, Architect SHBG Calibrator Kit, and Architect SHBG Control Kit with Models, 8K26-25, 8K26-01, Biokit, S.A. (2007) Summary page 5.

## Recalls of this device
- Mar 5, 2018 · Class II · Z-2092-2018: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

## Indications for use
ST AIA-PACK SHBG is designed for In Vitro Diagnostic Use Only for the quantitative measurement of sex hormone binding globulin (SHBG) in human serum or Na heparinized plasma on Tosoh AIA System Analyzers. The ST AIA-PACK SHBG assay is intended for use as an aid in the diagnosis of androgen disorders. The ST AIA-PACK SHBG Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK SHBG assay.

Source page: https://510kreport.com/device/K143075
Methodology: https://510kreport.com/methodology