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)
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.

View all Immunotech S.R.O. devices

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
126d slower than avg
Panel avg: 88d · 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 68
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