# K141772: Immulte 2000 Rubella Quantitative Igg Calibration Verification Material

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Aug 19, 2014 after 49 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). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133128: Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification Material, Pyrilinks-D Calibration, Siemens Healthcare Diagnostics, Inc. (2013) Summary page 4.

## Indications for use
The IMMULITE® Rubella Quantitative IgG Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Rubella Quantitative IgG assay on the IMMULITE 2000 systems. The IMMULITE® H. pylori IgG Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE H. pylori IgG assay on the IMMULITE 2000 systems. The IMMULITE® Toxoplasma Quantitative IgG Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Toxoplasma Quantitative IgG assay on the IMMULITE 2000 systems.

Source page: https://510kreport.com/device/K141772
Methodology: https://510kreport.com/methodology