Cleared Special

K191350 - ACTIVE® Free Testosterone RIA

K191350 is an FDA 510(k) clearance for ACTIVE Free Testosterone RIA, manufactured by Immunotech S.R.O.. The device is a Class 1 Chemistry device with product code CDZ cleared through the Special 510(k) pathway after a 214-day FDA review.

K191350 · Immunotech S.R.O. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2019
Decision
214d
Days
Class 1
Risk

K191350 is an FDA 510(k) clearance for the ACTIVE® Free Testosterone RIA. Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by Immunotech S.R.O. (Prague, CZ). The FDA issued a Cleared decision on December 20, 2019 after a review of 214 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K191350

510(k) Number K191350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2019
Decision Date December 20, 2019
Days to Decision 214 days
Submission Type Special
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
125d slower than avg
Panel avg: 89d · This submission: 214d
Pathway characteristics
Modification to existing cleared device.

CDZ Device Classification - Class 1, General Controls

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 84
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K191350 · ACTIVE® Free Testosterone RIA
Download PDF FDA Summary Immunotech S.R.O.