# K012208: Access Thyroglobulin Antibody and Calibrators on the Access Immunoassay Systems, Models 33890, 33895

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Sep 7, 2001 after 53 days
- Product code: DDC (Thyroglobulin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5870
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K834203: Flexxr* CPM System, Qarex Laboratories, Inc. (1984). Our OCR of the scanned summary read K834203, FDA’s number for Flexxr* CPM System (Qarex Laboratories, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Kalibre-R™ Thyroglobulin Antibody (TgAb) RIA Kit”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K062516: Access Thyroglobulin Antibody II Assay, Models A32898 (Reagent) and A36920 (Calibrators) (2006), 4 descendants of its own
- K112933: Access Thyroglobulin Anitbody (2011), 3 descendants of its own
- K213517: Access Thyroglobulin Antibody II (2023), 1 descendant of its own
- K250816: ADVIA Centaur Anti-Thyroglobulin II (aTgII) (2025), 0 descendants of its own
- K240996: Access Thyroglobulin Antibody II (2024), 0 descendants of its own

## Recalls of this device
- Oct 26, 2006 · Not classified · Z-0417-2007: Low end imprecision affecting both S0 calibrators and patient samples which can lead to inaccurate low level patient results when using the Access Thyroglobulin Antibody assay.

## Indications for use
The Access Thyroglobulin Antibody (TgAb) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access® Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto’s disease, nontoxic goiter, and Graves ‘disease.

Source page: https://510kreport.com/device/K012208
Methodology: https://510kreport.com/methodology