IDS-iSYS Total Testosterone
K-Number: K252728 · 2026-04-15
ApplicantImmunodiagnostic Systems Limited
Decision Date2026-04-15
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
IDS-iSYS Total Testosterone is a medical device manufactured by Immunodiagnostic Systems Limited. It received FDA 510(k) clearance on 2026-04-15 under approval number K252728. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the IDS-iSYS Total Testosterone?
IDS-iSYS Total Testosterone is a medical device that received FDA 510(k) clearance on 2026-04-15. It is manufactured by Immunodiagnostic Systems Limited. The 510(k) number is K252728.
When was IDS-iSYS Total Testosterone approved by the FDA?
IDS-iSYS Total Testosterone received FDA 510(k) clearance on 2026-04-15, under approval number K252728.
What company makes IDS-iSYS Total Testosterone?
IDS-iSYS Total Testosterone is manufactured by Immunodiagnostic Systems Limited.
What is the FDA product code for IDS-iSYS Total Testosterone?
The FDA product code for IDS-iSYS Total Testosterone is CDZ.
Other Devices by Immunodiagnostic Systems Limited
Related Devices (Code: CDZ)
K153577FREND Testosterone Test SystemNanoentek USA, Inc.
K151986ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve MaterialSiemens Healthcare Diagnostics, Inc.
K152185ARCHITECT SHBGBiokit, S.A.
K151529Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone CalibratorSiemens Healthcare Diagnostics, Inc.
K181017Free Testosterone AccuBind ELISA Test SystemMonobind, Inc.
K191350ACTIVE® Free Testosterone RIAImmunotech S.R.O.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.