# K950090: Orgentec Anti-Tpo Pia (Pin Immuno Assay)

- Pathway: 510(k) (Traditional)
- Applicant: American Laboratory Products Co., Ltd.
- Decided: Apr 21, 1995 after 101 days
- Product code: JZO (System, Test, Thyroid Autoantibody)
- Device class: 2
- Regulation: 21 CFR 866.5870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 2 cite it directly.
0 of 10 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
- K980206: Immulite Anti-TG AB (1998), 4 descendants of its own
- K991094: Immulite 2000 Anti-TG AB, Model L2KTG2, L2KTG6 (1999), 3 descendants of its own
- K963695: Immulite Anti-Tpo-AB (Lktoi,LKT05,Lktoz (1997), 3 descendants of its own
- K020672: Elecsys Anti-TG Test System (2002), 2 descendants of its own
- K991096: Immulite 2000 Anti-Tpo AB, Model L2KT02, L2KT06 (1999), 2 descendants of its own

Source page: https://510kreport.com/device/K950090
Methodology: https://510kreport.com/methodology