# K984228: IS Anti-Tpo Igg Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Columbia Bioscience, Inc.
- Decided: Feb 2, 1999 after 69 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.
No later device cites it as a predicate yet.
0 of 1 device 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 TPO Kit: named in the summary without a submission number

## Indications for use
The & TPO IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection and quantitation of antibodies against the Thyroid Peroxidase (TPO) antigen in serum as an aid in the diagnosis of thyroid autoimmune disease. The test can be performed either manually or in conjunction with the Mago Plus automated EIA processor.

Source page: https://510kreport.com/device/K984228
Methodology: https://510kreport.com/methodology