# K970146: Elecsys Calcheck Testosterone

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jan 30, 1997 after 15 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: 1 generation back to K924863 (1992). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924863: Aia-Pack FSH Calibration Verification Test Set, Tosoh Medics, Inc. (1992) Summary page 1.

## Most influential descendants
- K140505: Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve Material, and Testosterone Master Curve Material (2014), 3 descendants of its own
- K151986: ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material (2016), 2 descendants of its own
- K191533: ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG (2019), 0 descendants of its own
- K190121: Ids SHBG (2019), 0 descendants of its own

## Indications for use
The Boehringer Mannheim Elecsys CalCheck Testosterone is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Testosterone assay.

Source page: https://510kreport.com/device/K970146
Methodology: https://510kreport.com/methodology