# K133122: Immulite 2000; 3GALLERGY Specific Ige Control Verification Material (CVM), Total Ige Control Verification Material (CVM)

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Oct 30, 2013 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: 1 generation back to K102269 (2010). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102269: Elecsys Ige Calcheck 5, Roche Diagnostics (2010) Summary page 2.

## Most influential descendants
- K143680: ADVIA Centaur IgE Master Curve Material (2015), 0 descendants of its own

## Indications for use
The IMMULITE 2000 3gAllergy Specific IgE Calibration Verification Material (CVM) is intended for in vitro diagnostic use, as a control for calibration verification of the IMMULITE 2000 3gAllergy Specific IgE assay on IMMULITE 2000 systems as indicated in the CVM Package Insert. The IMMULITE 2000 Total IgE Calibration Verification Material (CVM) is intended for in vitro diagnostic use, as a control for calibration verification of the IMMULITE 2000 Total IgE assay on IMMULITE 2000 systems as indicated in the CVM Package Insert.

Source page: https://510kreport.com/device/K133122
Methodology: https://510kreport.com/methodology