# K963695: Immulite Anti-Tpo-AB (Lktoi,LKT05,Lktoz

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Jan 17, 1997 after 123 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: 1 generation back to K950090 (1995). 1 ancestor in all.
3 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)
- K950090: Orgentec Anti-Tpo Pia (Pin Immuno Assay), American Laboratory Products Co., Ltd. (1995) Summary page 1.

## Most influential descendants
- K991096: Immulite 2000 Anti-Tpo AB, Model L2KT02, L2KT06 (1999), 2 descendants of its own
- 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 Anti-TPO Ab is a solid-phase, enzyme chemiluminescent immunoassay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of antibodies against thyroid peroxidase (TPO) in serum and EDTA plasma. It is intended strictly for in vitro diagnostic use as an aid in the clinical diagnosis of thyroid diseases.

Source page: https://510kreport.com/device/K963695
Methodology: https://510kreport.com/methodology