# K143504: IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Jan 14, 2015 after 35 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). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140541: Immulite 2000: C-Peptide Calibration Verification Material, SHBG Calibration Verification Material, Total Testosterone C, Siemens Healthcare Diagnostics, Inc. (2014) Summary page 4.
- K140258: Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification Material, Siemens Healthcare Diagnostics, Inc. (2014) Summary page 12.

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

Source page: https://510kreport.com/device/K143504
Methodology: https://510kreport.com/methodology