# K060027: Architect Dhea-S Calibrators (a-F) and Controls (Low, Medium and High)

- Pathway: 510(k) (Traditional)
- Applicant: Biokit, S.A.
- Decided: Jan 26, 2006 after 22 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) DPC IMMULITE® DHEA-SO4 Calibrators and Controls: named in the summary without a submission number

## Indications for use
Calibrators The ARCHITECT ® DHEA-S Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of DHEA-S in human serum and plasma. Controls ARCHITECT ® DHEA-S Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of DHEA-S in human serum and plasma. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K060027
Methodology: https://510kreport.com/methodology