# K142811: IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Oct 29, 2014 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: 7 generations back to K950469 (1995). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140258: Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification Material, Siemens Healthcare Diagnostics, Inc. (2014) Summary page 4.
- K133128: Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification Material, Pyrilinks-D Calibration, Siemens Healthcare Diagnostics, Inc. (2013) Summary page 11.

## Indications for use
The IMMULITE® 2000 LH Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE LH assay on the IMMULITE 2000 systems. The IMMULITE® 2000 Free T3 Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Free T3 assay on the IMMULITE 2000 systems The IMMULITE® 2000 Gastrin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Gastrin assay on the IMMULITE 2000 systems

Source page: https://510kreport.com/device/K142811
Methodology: https://510kreport.com/methodology