# K021326: Vidas Testosterone (Tes), Model 30 418

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Jul 18, 2002 after 83 days
- Product code: CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone)
- Device class: 1
- Regulation: 21 CFR 862.1680
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K813401 (1981). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K813401: Coat-a-Count Testosterone Ria Kit, Diagnostic Products Corp. (1981) Summary page 1.
- K934562: Ciba Corning Acs Testosterone Immunoassay, Ciba Corning Diagnostics Corp. (1993) Summary page 1.

## Most influential descendants
- K141133: VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II (2015), 0 descendants of its own

## Recalls of this device
- May 15, 2017 · Class II · Z-2339-2017: Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests with VIDAS Testosterone.

## Indications for use
VDAS Testosterone is an automated test for use on the WAS analyzer for the enzyme immunoassay measure of total testosterone in human serum or plasma (heparin), using the ELFA technique (Enzyme Linked Fluorescent Assay). It is intended as an aid in the disgnosis and management of conditions involving excess or deficiency of this androgen.

Source page: https://510kreport.com/device/K021326
Methodology: https://510kreport.com/methodology