# K031269: Access Thyroglobulin Reagents on the Access Immunoassay Systems

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: May 2, 2003 after 11 days
- Product code: MSW (System, Test, Thyroglobulin)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002905 (2000). 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)
- K002905: Access Thyroglobulin Reagents on the Access Analyzer, Beckman Coulter, Inc. (2000) Summary page 1.

## Recalls of this device
- Jul 10, 2025 · Class II · Z-2322-2025: Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely increased Access Thyroglobulin results may lead a physician to pursue unnecessary diagnostic imaging stud
- Jul 6, 2023 · Class II · Z-0100-2024: It has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator cards for use with the Thyg reagent packs distributed in April 2023 will cause a decrease of
- Apr 30, 2019 · Class II · Z-2240-2020: The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays (Free T3-REF A13422, Total T3-REF 33830
- May 9, 2017 · Class II · Z-2636-2017: The Access immunoassays are susceptible to biotin interference.
- Jul 28, 2015 · Class II · Z-2733-2015: Beckman Coulter, Inc. is recalling Access Thyroglobulin reagent packs because some may exhibit greater than 10% imprecision at concentrations <10 ng/mL.
- Oct 18, 2010 · Not classified · Z-2215-2011: The recall was initiated because In addition to Access Tg Sample Diluent, an additional diluent, Access Wash Buffer II, was added to Thyroglobulin instructions for use (IFU) for evaluation of samples 

## Indications for use
The Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin levels in human serum and plasma, using the Access Immunoassay Systems. This device is intended to aid in the monitoring for the presence of local and metastatic thyroid tissue in patients who have had thyroid gland ablation (using thyroid surgery with or without radioactivity) and who lack serum thyroglobulin antibodies.

Source page: https://510kreport.com/device/K031269
Methodology: https://510kreport.com/methodology