# K991096: Immulite 2000 Anti-Tpo AB, Model L2KT02, L2KT06

- Pathway: 510(k) (Special)
- Applicant: Diagnostic Products Corp.
- Decided: May 13, 1999 after 42 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
Longest line of descent: 2 generations back to K950090 (1995). 2 ancestors in all.
2 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)
- K963695: Immulite Anti-Tpo-AB (Lktoi,LKT05,Lktoz, Diagnostic Products Corp. (1997) Summary page 1.

## Most influential descendants
- K061382: Access Tpo Antibody, and Access Tpo Antibody Calibrators, Models A12985 and A18227 (2006), 1 descendant of its own
- K240469: Access TPO Antibody (2024), 0 descendants of its own

## Indications for use
IMMULITE 2000 Anti-TPO Ab is for in vitro diagnostic use with the IMMULITE 2000 Analyzer — for the quantitative measurement of antithyroid peroxidase (TPO) antibodies in serum and EDTA plasma, as an aid in the clinical diagnosis of thyroid diseases.

Source page: https://510kreport.com/device/K991096
Methodology: https://510kreport.com/methodology