# K982250: Access Free T4 Reagents on the Access Immunoassay Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Jul 14, 1998 after 18 days
- Product code: CEC (Radioimmunoassay, Free Thyroxine)
- Device class: 2
- Regulation: 21 CFR 862.1695
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) IMx® Free T4 Assay: named in the summary without a submission number

## Most influential descendants
- K240273: Access Free T4 (2024), 0 descendants of its own

## Recalls of this device
- Apr 30, 2019 · Class II · Z-2237-2020: 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-2637-2017: The Access immunoassays are susceptible to biotin interference.
- Nov 11, 2010 · Not classified · Z-1945-2011: The recall was initiated because the stability claim for Access Free T4 calibrator lot 014769 is not met. The affected T4 calibrator lot can produce quality control and patient results that are errone
- Mar 24, 2010 · Not classified · Z-2658-2010: The recall was initiated after Beckman Coulter determined that kit boxes for Access Free T4 reagent (REF 33880), lot number 916293 may contain reagent packs labeled as Access Vitamin B12, (REF 33000),

## Indications for use
The ACCESS® Free T4 Assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free thyroxine levels in human or plasma (heparin) using the ACCESS® Immunoassay System. A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in human serum or plasma (heparin). Levels of free thyroxine in plasma are tholight to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

Source page: https://510kreport.com/device/K982250
Methodology: https://510kreport.com/methodology