IDS-iSYS Total Testosterone— 510(k) K252728

Name: FDA 510(k) clearance K252728
Creator: U.S. Food and Drug Administration
Published: 2026-04-15

Substantially Equivalent

Immunodiagnostic Systems Limited

FDA 510(k) clearance K252728 for IDS-iSYS Total Testosterone, Substantially Equivalent on 2026-04-15. Applicant: Immunodiagnostic Systems Limited. Device class: 1.

Summary

Immunodiagnostic Systems' IDS-iSYS Total Testosterone is filed under product code CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone).

Class I, 21 CFR 862.1680. It came in as a Traditional 510(k), and Clinical Chemistry is both the classification panel and the review panel.

Immunodiagnostic Systems filed from Tyne & Wear, the United Kingdom. Review took 230 calendar days (August 28, 2025 to April 15, 2026).

Clearance details

Applicant: Immunodiagnostic Systems Limited
Product code: Product code CDZ
Device class: Class 1
Regulation: 21 CFR 862.1680
Advisory panel: Clinical Chemistry
Date received: 2025-08-28
Decision date: 2026-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tyne & Wear, GB

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.