# K924862: Aia-Pack HCG Calibration Verification Test Set

- Pathway: 510(k) (Traditional)
- Applicant: Tosoh Medics, Inc.
- Decided: Dec 28, 1992 after 91 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.
55 later devices descend from it; 9 cite it directly.
0 of 56 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
- K963147: Elecsys Calcheck TSH (1996), 32 descendants of its own
- K963167: Elecys Calcheck T 3 (1996), 17 descendants of its own
- K111552: Elecsys T3 Calcheck 5 (2011), 16 descendants of its own
- K112528: Elecsys T4 Calcheck 5 (2011), 15 descendants of its own
- K974383: Elecsys Calcheck Vitamin B12 (1997), 10 descendants of its own

Source page: https://510kreport.com/device/K924862
Methodology: https://510kreport.com/methodology