# K002905: Access Thyroglobulin Reagents on the Access Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Oct 19, 2000 after 31 days
- Product code: MSW (System, Test, Thyroglobulin)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K220972: Access Thyroglobulin (2023), 3 descendants of its own
- K241423: Access Thyroglobulin (2024), 1 descendant of its own
- K242981: Atellica IM Thyroglobulin (Tg) (2025), 0 descendants of its own
- K240927: Access Thyroglobulin (2024), 0 descendants of its own
- K221890: Elecsys Tg II (2023), 0 descendants of its own

## Recalls of this device
- 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 

Source page: https://510kreport.com/device/K002905
Methodology: https://510kreport.com/methodology