# K964889: Elecsys Testosterone Assay

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Mar 18, 1997 after 102 days
- Product code: CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone)
- Device class: 1
- Regulation: 21 CFR 862.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K081349: Coat-A-Count® Total Testosterone Assay. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K093421: Elecsys Testosterone II Immunoassay (2010), 11 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
- K120009: Testosterone Test System; Calibrator; and Quality Control Material (Assayed and Unassayed) (2012), 2 descendants of its own
- K211685: Elecsys Testosterone II (2022), 1 descendant of its own
- K122793: Liaison Testosterone; Liaison Testosterone Control Set (2013), 1 descendant of its own

## Indications for use
Immunoassay for the in vitro quantitative determination of testosterone in serum and plasma.

Source page: https://510kreport.com/device/K964889
Methodology: https://510kreport.com/methodology