# K133124: Immulite 2000; Total T3 Calibration Verification Material, Total T4 Calibration Verification Material, Total TBG Calibra

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Oct 25, 2013 after 25 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). 10 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111552: Elecsys T3 Calcheck 5, Roche Diagnostics (2011)
- K112528: Elecsys T4 Calcheck 5, Roche Diagnostics Corporation (2011) Summary page 6.
- K020217: Acs:180 and Advia Centaur Ipth Immunoassay, Bayer Diagnostics Corp. (2002) Summary page 11.
- K102904: Enhanced Estradiol (EE2) Master Curve Material, Siemens Healthcare Diagnostics (2010) Summary page 21.

## Cited in the summary but kept off the family tree
- K096429: Elecsys FSH CalCheck. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## Most influential descendants
- K140818: Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration Verification Material, 2000 Prolactin C (2014), 3 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
- 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 Total T3 Calibration Verification Material (CVM) is intended for in vitro diagnostic use in the verification of calibration of the IMMULITE Total T3 assay on the IMMULITE 2000 systems. The IMMULITE Total T4 Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Total T4 assay on the IMMULITE 2000 systems. The IMMULITE TBG Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE TBG assay on the IMMULITE 2000 systems. The IMMULITE FSH Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE FSH assay on the IMMULITE 2000 systems. The IMMULITE Estradiol Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Estradiol assay on the IMMULITE 2000 systems.

Source page: https://510kreport.com/device/K133124
Methodology: https://510kreport.com/methodology