# K140818: Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration Verification Material, 2000 Prolactin C

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: May 1, 2014 after 30 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: 6 generations back to K950469 (1995). 23 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133124: Immulite 2000; Total T3 Calibration Verification Material, Total T4 Calibration Verification Material, Total TBG Calibra, Siemens Healthcare Diagnostics, Inc. (2013) Summary page 1.
- K133128: Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification Material, Pyrilinks-D Calibration, Siemens Healthcare Diagnostics, Inc. (2013) Summary page 5.

## Most influential descendants
- K143687: ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material (2015), 0 descendants of its own
- K143636: IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material (2015), 0 descendants of its own
- K143352: IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material (2014), 0 descendants of its own

## Indications for use
The IMMULITE® Free T4 Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Free T4 assay on the IMMULITE 2000 systems. The IMMULITE® IGF-I Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE IGF-I assay on the IMMULITE 2000 systems. The IMMULITE® Prolactin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of the IMMULITE Prolactin assay on the IMMULITE 2000 systems.

Source page: https://510kreport.com/device/K140818
Methodology: https://510kreport.com/methodology