# K903628: Aia-Pack Iri

- Pathway: 510(k) (Traditional)
- Applicant: Tosoh Corp.
- Decided: Sep 7, 1990 after 28 days
- Product code: CFP (Radioimmunoassay, Immunoreactive Insulin)
- Device class: 1
- Regulation: 21 CFR 862.1405
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021535: Advia Cantaur and Acs:180 Insulin Calibrator (2002), 3 descendants of its own
- K060359: Archiect Insulin and Controls, Model 8K41-01, 8K41-10 (2006), 1 descendant of its own
- K171168: VITROS Immunodiagnostic Products Insulin Calibrators (2017), 0 descendants of its own
- K162538: ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator (2016), 0 descendants of its own

Source page: https://510kreport.com/device/K903628
Methodology: https://510kreport.com/methodology