# K110061: CVM, Unconjugated Estriol (UE3) Calibration Verification Material

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Sep 21, 2011 after 254 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: 4 generations back to K950469 (1995). 4 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102904: Enhanced Estradiol (EE2) Master Curve Material, Siemens Healthcare Diagnostics (2010) Summary page 1.

## Most influential descendants
- 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
- K140818: Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration Verification Material, 2000 Prolactin C (2014), 3 descendants of its own
- K140541: Immulite 2000: C-Peptide Calibration Verification Material, SHBG Calibration Verification Material, Total Testosterone C (2014), 2 descendants of its own
- K141444: Immulite 2000; Cortisol Calibration Verification Material, Folic Acid Calibration Verification Material, Vitamin B12 Cal (2014), 1 descendant of its own

## Indications for use
For in vitro diagnostic use as a control for calibration verification of the IMMULITE® Unconjugated Estriol (uE3) assays on the IMMULITE/IMMULITE 1000, 2000 systems. The calibration verification material is assayed control with four levels. The analyte levels for IMMULITE 1000 are 0.00, 0.16, 2.70 and 11.2 ng/ml, and 0.00, 0.19, 2.90 and 12.00 for IMULITE 2000 systems. The matrix is estriol in processed horse serum.

Source page: https://510kreport.com/device/K110061
Methodology: https://510kreport.com/methodology