# K140258: Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification Material

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Mar 5, 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: 6 generations back to K950469 (1995). 16 ancestors in all.
7 later devices descend from it; 6 cite it directly.
0 of 24 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
- K141444: Immulite 2000; Cortisol Calibration Verification Material, Folic Acid Calibration Verification Material, Vitamin B12 Cal (2014), 1 descendant of its own
- K143373: IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material (2015), 0 descendants of its own
- K143636: IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material (2015), 0 descendants of its own
- K143639: IMMULITE 2000 CEA 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 2000 DHEA-S04 Calibration Verification Material (CVM) is intended for in vitro diagnostic use in the verification of calibration of the IMMULITE DHEA-S04 assay on the IMMULITE 2000 systems. The IMMULITE 2000 Third Generation TSH Calibration Verification Material (CVM) is intended for in vitro diagnostic use in the verification of calibration of the IMMULITE Third Generation TSH assay on the IMMULITE 2000 systems. The IMMULITE 2000 Intact PTH Calibration Verification Material (CVM) is intended for in vitro diagnostic use in the verification of calibration of the IMMULITE Intact PTH assay on the IMMULITE 2000 systems.

Source page: https://510kreport.com/device/K140258
Methodology: https://510kreport.com/methodology