# K103683: Immulite/Immulite 1000 Progesterone Calibration Verification (CVM)

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Apr 28, 2011 after 132 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.
1 later device descends from it; 1 cites it directly.
0 of 6 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
- K143376: ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material (2014), 0 descendants of its own

## Indications for use
For in vitro diagnostic use, for the calibration verification of the IMMULITE®/IMMULITE 1000 Progesterone assay (LKPW).

Source page: https://510kreport.com/device/K103683
Methodology: https://510kreport.com/methodology