# K143373: IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Feb 26, 2015 after 93 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)
- K140258: Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification Material, Siemens Healthcare Diagnostics, Inc. (2014) Summary page 5.
- K140541: Immulite 2000: C-Peptide Calibration Verification Material, SHBG Calibration Verification Material, Total Testosterone C, Siemens Healthcare Diagnostics, Inc. (2014) Summary page 9.

## Indications for use
The IMMULITE® 2000 Calcitonin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Calcitonin assay on the IMMULITE 2000 systems. The IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE PAP assay on the IMMULITE 2000 systems.

Source page: https://510kreport.com/device/K143373
Methodology: https://510kreport.com/methodology