# K951848: Aia-Pack CPR Assay

- Pathway: 510(k) (Traditional)
- Applicant: Tosoh Medics, Inc.
- Decided: Feb 13, 1996 after 298 days
- Product code: JKD (Radioimmunoassay, C-Peptides Of Proinsulin)
- Device class: 1
- Regulation: 21 CFR 862.1135
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K021532: Advia Centaur and Acs:180 C-Peptide Calibrator (2002), 1 descendant of its own
- K140648: ST Aia-Pack C-Peptide II Calibrator Set (2014), 0 descendants of its own
- K082141: Architect C-Peptide Calibrators, and Architect C-Peptide Controls, Models 3L53-01, 3L53-10 (2008), 0 descendants of its own

Source page: https://510kreport.com/device/K951848
Methodology: https://510kreport.com/methodology