# K143352: IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Dec 24, 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). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 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.
- K140818: Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration Verification Material, 2000 Prolactin C, Siemens Healthcare Diagnostics, Inc. (2014) Summary page 11.

## Indications for use
The IMMULITE® Ferritin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Ferritin assay on the IMMULITE 2000 systems The IMMULITE® IGFBP-3 Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE IGFBP-3 assay on the IMMULITE 2000 systems

Source page: https://510kreport.com/device/K143352
Methodology: https://510kreport.com/methodology