# K132391: Immulite 2000 Anti-TG AB Calibration Verification Material, Immulite 2000 Anti-Tpo AB Calibration Verificatin Material

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Helathcare Diagnostics, Inc.
- Decided: Sep 20, 2013 after 50 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: 3 generations back to K924862 (1992). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020369: Elecsys Anti-TG Calcheck, Roche Diagnostics Corp. (2002) Summary page 1.
- K001014: Elecsys Anti-Tpo Calcheck, Roche Diagnostics Corp. (2000) Summary page 5.
- K020217: Acs:180 and Advia Centaur Ipth Immunoassay, Bayer Diagnostics Corp. (2002) Summary page 9.

## Indications for use
The IMMULITE® Anti-TO Ab Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Anti-TO Ab assay on the IMMULITE 2000 systems as indicated in the CVM Package Insert. The IMMULITE® Thyroglobulin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Thyroglobulin assay on the IMMULITE 2000 systems as indicated in the CVM Package Insert. The IMMULITE® Anti-TPO All Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Anti-TPO Ab assay on the IMMULITE 2000 systems as indicated in the CVM Package Insert.

Source page: https://510kreport.com/device/K132391
Methodology: https://510kreport.com/methodology