# K973743: Access Estradiol Reagents on the Access Immunoassay Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Oct 31, 1997 after 30 days
- Product code: CHP (Radioimmunoassay, Estradiol)
- Device class: 1
- Regulation: 21 CFR 862.1260
- Recalls of this device: 2 (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) Abbott IMx® Estradiot Kit: named in the summary without a submission number

## Most influential descendants
- K080166: Access Estradiol Calibrators on the Access Immunoassay Systems, Model 33545 (2008), 0 descendants of its own

## Recalls of this device
- Mar 4, 2010 · Not classified · Z-0448-2011: The recall was initiated after Beckman Coulter confirmed that three lots of Access Estradiol reagent (REF 33540) contains an incorrect raw material which may produce incorrect patient results.
- May 8, 2003 · Not classified · Z-0872-03: Short volume, resulting possibility of falsely elevated results.

## Indications for use
The Access Estradiol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of estradiol levels in human serum, using the Access Immunoassay System.

Source page: https://510kreport.com/device/K973743
Methodology: https://510kreport.com/methodology