# K133128: Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification Material, Pyrilinks-D Calibration

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Oct 22, 2013 after 22 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: 5 generations back to K950469 (1995). 15 ancestors in all.
13 later devices descend from it; 7 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092168: Elecsys HCG+B Calcheck 5, Roche Diagnostics (2009) Summary page 1.
- K101075: Elecsys Insulin Calcheck 5, Roche Diagnostics Corp. (2010) Summary page 7.
- K110061: CVM, Unconjugated Estriol (UE3) Calibration Verification Material, Siemens Healthcare Diagnostics (2011) Summary page 12.
- K100715: Audit Microcv Homocysteine Linearity Set, Model 704M-5, Aalto Scientific, Ltd. (2010) Summary page 17.

## Most influential descendants
- 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
- 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

## Indications for use
The IMMULITE® HCG Calibration Verification Material (CVM) is intended for in vitro diagnostic use in the verification of calibration of the IMMULITE HCG assay on the IMMULITE 2000 systems. The IMMULITE® Insulin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Insulin assay on the IMMULITE 2000 systems. The IMMULITE® Pyrilinks-D Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Pyrilinks-D assay on the IMMULITE 2000 systems. The IMMULITE® Homocysteine Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Homocysteine assay on the IMMULITE 2000 systems. The IMMULITE® Growth Hormone Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Growth Hormone assay on the IMMULITE 2000 systems.

Source page: https://510kreport.com/device/K133128
Methodology: https://510kreport.com/methodology