Cleared Traditional

Elecsys Testosterone II

K211685 · Roche Diagnostics · Chemistry
May 2022
Decision
338d
Days
Class 1
Risk

About This 510(k) Submission

K211685 is an FDA 510(k) clearance for the Elecsys Testosterone II, a Radioimmunoassay, Testosterones And Dihydrotestosterone (Class I — General Controls, product code CDZ), submitted by Roche Diagnostics (Indianpolis, US). The FDA issued a Cleared decision on May 6, 2022, 338 days after receiving the submission on June 2, 2021. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1680.

Submission Details

510(k) Number K211685 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2021
Decision Date May 06, 2022
Days to Decision 338 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CDZ — Radioimmunoassay, Testosterones And Dihydrotestosterone
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1680

Similar Devices — CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone

All 87
IDS-iSYS Free Testosterone
K240865 · Immunodiagnostic Systems Limited · Oct 2024
Access SHBG
K233480 · Beckman Coulter, Inc. · Feb 2024
Access Testosterone
K223405 · Beckman Coulter, Inc. · Jan 2023
LIAISON Testosterone xt
K201908 · DiaSorin, Inc. · Oct 2020
ACTIVE? Free Testosterone RIA
K191350 · Immunotech S.R.O. · Dec 2019
ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG
K191533 · Siemens Healthcare Diagnostics, Inc. · Aug 2019