# K140541: Immulite 2000: C-Peptide Calibration Verification Material, SHBG Calibration Verification Material, Total Testosterone C

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Apr 1, 2014 after 28 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: 6 generations back to K950469 (1995). 16 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 19 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 1.

## Most influential descendants
- K143373: IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material (2015), 0 descendants of its own
- K143504: IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material (2015), 0 descendants of its own

## Indications for use
The IMMULITE® C-Peptide Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE C-Peptide assay on the IMMULITE 2000 systems. The IMMULITE® SHBG Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE SHBG assay on the IMMULITE 2000 systems. The IMMULITE® Total Testosterone Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Total Testosterone assay on the IMMULITE 2000 systems.

Source page: https://510kreport.com/device/K140541
Methodology: https://510kreport.com/methodology