# K102904: Enhanced Estradiol (EE2) Master Curve Material

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Nov 23, 2010 after 53 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K950469 (1995). 3 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062501: Validate Thyroid Calibration Verification / Linearity Test Set, Model 901, Maine Standards Co. (2006) Summary page 1.

## Most influential descendants
- K110061: CVM, Unconjugated Estriol (UE3) Calibration Verification Material (2011), 14 descendants of its own
- K133128: Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification Material, Pyrilinks-D Calibration (2013), 13 descendants of its own
- K140258: Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification Material (2014), 7 descendants of its own
- K133124: Immulite 2000; Total T3 Calibration Verification Material, Total T4 Calibration Verification Material, Total TBG Calibra (2013), 5 descendants of its own
- K140818: Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration Verification Material, 2000 Prolactin C (2014), 3 descendants of its own

## Indications for use
The ADVIA Centaur® Enhanced Estradiol (eE2) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range in the ADVIA Centaur® Enhanced Estradiol (eE2) assay.

Source page: https://510kreport.com/device/K102904
Methodology: https://510kreport.com/methodology