# K980206: Immulite Anti-TG AB

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: May 1, 1998 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
Longest line of descent: 1 generation back to K950090 (1995). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 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 2.

## Most influential descendants
- K991094: Immulite 2000 Anti-TG AB, Model L2KTG2, L2KTG6 (1999), 3 descendants of its own
- K020672: Elecsys Anti-TG Test System (2002), 2 descendants of its own
- K053426: Roche Elecsys Anti-TG (2006), 1 descendant of its own
- K222610: Elecsys Anti-Tg (2023), 0 descendants of its own

## Indications for use
IMMULITE® Anti-TG Ab is a solid-phase, two-step chemiluminescent enzyme immunometric assay for use with the IMMULITE® Automated Immunoassay Analyzer and designed for the quantitative measurement of antibodies against thyroglobulin (TG) in serum, EDTA, heparinized, and citrate 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/K980206
Methodology: https://510kreport.com/methodology