# K924863: Aia-Pack FSH Calibration Verification Test Set

- Pathway: 510(k) (Traditional)
- Applicant: Tosoh Medics, Inc.
- Decided: Nov 16, 1992 after 49 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.
15 later devices descend from it; 5 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K970147: Elecsys Calcheck Prolactin (1997), 6 descendants of its own
- K053059: Roche Diagnostics Elecsys Prolactin II Calcheck (2005), 5 descendants of its own
- K060585: Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol Acth (2006), 4 descendants of its own
- K970146: Elecsys Calcheck Testosterone (1997), 4 descendants of its own
- K140505: Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve Material, and Testosterone Master Curve Material (2014), 3 descendants of its own

Source page: https://510kreport.com/device/K924863
Methodology: https://510kreport.com/methodology