# K991094: Immulite 2000 Anti-TG AB, Model L2KTG2, L2KTG6

- 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: 2 (0 Class I)
- 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.
3 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)
- K980206: Immulite Anti-TG AB, Diagnostic Products Corp. (1998) Summary page 1.

## Most influential descendants
- 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

## Recalls of this device
- Apr 23, 2024 · Class II · Z-1886-2024: The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785, 786, 787, 788, 789, 790, 791, 792 and 793), of IMMULITE 2000 Anti-TG Ab.
- Apr 23, 2024 · Class II · Z-1887-2024: The potential for falsely elevated patient sample results when using impacted lots (785, 790, 791, and 793) of IMMULITE 2000 Anti-TG Ab.

## Indications for use
IMMULITE 2000 Anti-TG Ab is for in vitro diagnostic use with the IMMULITE 2000 Analyzer for the quantitative measurement of autoantibodies to thyroglobulin (TG) in serum, EDTA, and heparinized plasma, as an aid in the clinical diagnosis of thyroid diseases.

Source page: https://510kreport.com/device/K991094
Methodology: https://510kreport.com/methodology