# K143636: IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Feb 25, 2015 after 65 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: 8 generations back to K950469 (1995). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141444: Immulite 2000; Cortisol Calibration Verification Material, Folic Acid Calibration Verification Material, Vitamin B12 Cal, Siemens Healthcare Diagnostics, Inc. (2014) Summary page 5.
- K140818: Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration Verification Material, 2000 Prolactin C, Siemens Healthcare Diagnostics, Inc. (2014) Summary page 10.

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

Source page: https://510kreport.com/device/K143636
Methodology: https://510kreport.com/methodology