# K080166: Access Estradiol Calibrators on the Access Immunoassay Systems, Model 33545

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Mar 19, 2008 after 56 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970126 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973743: Access Estradiol Reagents on the Access Immunoassay Analyzer, Beckman Instruments, Inc. (1997) Summary page 1.
- K970126: Access Estradiol Reagents on the Access Immunoassay Analyzer (33550,33540,33545), Bio-Rad Laboratories, Inc. (1997) Summary page 1.

## Indications for use
The Access Estradiol Calibrators are intended to calibrate the Access Estradiol assay for the quantitative determination of estradiol levels in human serum and plasma using the Access Immunoassay Systems.

Source page: https://510kreport.com/device/K080166
Methodology: https://510kreport.com/methodology