Cleared Traditional

IDS-iSYS Free Testosterone (K240865) - FDA 510(k) Clearance

Class I Chemistry device.

K240865 · Immunodiagnostic Systems Limited · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
209d
Days
Class 1
Risk

K240865 is an FDA 510(k) clearance for the IDS-iSYS Free Testosterone. Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by Immunodiagnostic Systems Limited (Tyne & Wear, GB). The FDA issued a Cleared decision on October 23, 2024 after a review of 209 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1680 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Immunodiagnostic Systems Limited devices

Submission Details

510(k) Number K240865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2024
Decision Date October 23, 2024
Days to Decision 209 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 88d · This submission: 209d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1680
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone

All 36
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K240865.
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K201908 · DiaSorin, Inc. · Oct 2020
ACTIVE® Free Testosterone RIA
K191350 · Immunotech S.R.O. · Dec 2019