# K993585: Varelisa Tpo Antibodies, Model 12348/12396

- Pathway: 510(k) (Traditional)
- Applicant: Pharmacia & Upjohn Co.
- Decided: Jan 5, 2000 after 75 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) elias™ TM Antibodies: named in the summary without a submission number

## Most influential descendants
- K151799: EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 (2016), 0 descendants of its own

## Indications for use
The Varelisa TPO Antibodies EIA kit is designed for the quantitative and qualitative determination of TPO (thyroid peroxidase) antibodies in serum or plasma to aid in the diagnosis of thyroid diseases such as Autoimmune Thyroiditis and Graves’ Disease.

Source page: https://510kreport.com/device/K993585
Methodology: https://510kreport.com/methodology