# K060818: Architect SHBG Reagent Kit, Architect SHBG Calibrator Kit, and Architect SHBG Control Kit with Models, 8K26-25, 8K26-01

- Pathway: 510(k) (Traditional)
- Applicant: Biokit, S.A.
- Decided: Jan 23, 2007 after 302 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: 2 generations back to K941797 (1994). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031717: Elecsys SHBG Immunoassay, Roche Diagnostics Corp. (2003) Summary page 1.
- (no number) Elecsys® SHBG CalSet: named in the summary without a submission number
- (no number) Elecsys PreciControl Universal: named in the summary without a submission number

## Most influential descendants
- K152185: Architect SHBG (2016), 0 descendants of its own
- K143075: ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set (2015), 0 descendants of its own

## Recalls of this device
- Apr 18, 2017 · Class II · Z-2613-2017: Firm has identified that ARCHITECT SHBG results generated with the Potassium EDTA specimen tube type may demonstrate a negative shift relative to results generated with serum. There is a potential for

## Indications for use
Reagents The ARCHITECT® SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT i System. The ARCHITECT SHBG assay is intended for use as an aid in the diagnosis of androgen disorders. Calibrators The ARCHITECT® SHBG Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of SHBG in human serum and plasma. Controls ARCHITECT® SHBG Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of SHBG in human serum and plasma. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K060818
Methodology: https://510kreport.com/methodology