# K052407: Architect Anti-Tpo Immunoassay, Calibrators & Controls

- Pathway: 510(k) (Traditional)
- Applicant: Fisher Diagnostics
- Decided: Jul 18, 2006 after 320 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: 1 generation back to K020348 (2002). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020348: Abbott Axsym Anti-Thyroid-Peroxidase, MODELS5F57 Comprising Standards/Calibrators, Axis-Shield Diagnostics, Ltd. (2002) Summary page 1.

## Most influential descendants
- K250250: ADVIA Centaur Anti-Thyroid Peroxidase II (2025), 0 descendants of its own

## Recalls of this device
- Apr 24, 2025 · Class II · Z-1843-2025: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the
- Apr 24, 2023 · Class III · Z-1696-2023: Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU).

## Indications for use
ARCHITECT® Anti-TPO is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma (EDTA and Heparin) on the ARCHITECT® i System. The ARCHITECT® Anti-TPO assay is intended for use as an aid in the diagnosis of autoimmune thyroid disease. The ARCHITECT® Anti-TPO Calibrators are for the calibration of the ARCHITECT® i System when used for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma. The ARCHITECT® Anti-TPO 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 thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma.

Source page: https://510kreport.com/device/K052407
Methodology: https://510kreport.com/methodology