# K052308: Architect Anti-TG Immunoassay Reagents, Calibrators, Controls and System Assay CD-Rom

- Pathway: 510(k) (Traditional)
- Applicant: Fisher Diagnostics
- Decided: May 10, 2006 after 259 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 K972070 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983992: Nichols Advantage Thyroglobulin Autoantibodies (Tgab) Assay, Nichols Institute Diagnostics (1999) Summary page 1.
- K972070: Nichols Advantage Chemiluminescence Tri-Level Specialty Controls, Nichols Institute Diagnostics (1997) Summary page 1.

## Indications for use
ARCHITECT® Anti-Tg is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of the IgG class of thyroglobulin autoantibodies (anti-Tg) in human serum and plasma on the ARCHITECT i System. The ARCHITECT Anti-Tg assay is intended for use as an aid in the diagnosis of thyroid disease. The ARCHITECT® Anti-Tg Calibrators are for the calibration of the ARCHITECT® i System when used for the quantitative determination of IgG class of thyroglobulin autoantibodies (anti-Tg) in human serum and plasma. The ARCHITECT® Anti-Tg Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT® i System (reagents, calibrators and instrument) when used for the quantitative determination of the IgG class of thyroglobulin autoantibodies (anti-Tg) in human serum and plasma.

Source page: https://510kreport.com/device/K052308
Methodology: https://510kreport.com/methodology