# K982866: Nichols Advantage Chemiluminescence Thyroid Peroxidase Autoantibodies Immunoassay, Model # 62-701521

- Pathway: 510(k) (Traditional)
- Applicant: Nichols Institute Diagnostics
- Decided: Oct 16, 1998 after 63 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 K931311 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931311: Thyroid Peroxidase Auto Antibodies (Tpo) Immun Kit, Nichols Institute (1993) Summary page 1.

## Indications for use
The Nichols Advantage™ Chemiluminescence Thyroid Peroxidase Autoantibodies Immunoassay is intended for use on the Nichols Advantage™ Specialty System for the quantitative determination of Thyroid Peroxidase Autoantibodies (TPOAb) in human serum as an aid in the diagnosis and assessment of patients with autoimmune thyroid disease.

Source page: https://510kreport.com/device/K982866
Methodology: https://510kreport.com/methodology