Cleared Special

K101388 - FASTPACK TESTO IMMUNOASSAY

K101388 is the FDA 510(k) clearance for FASTPACK TESTO IMMUNOASSAY by Qualigen, Inc.. It is a Class 1 Chemistry device (product code CDZ) cleared through the Special 510(k) pathway after a 277-day FDA review.

K101388 · Qualigen, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
277d
Days
Class 1
Risk

K101388 is an FDA 510(k) clearance for the FASTPACK TESTO IMMUNOASSAY. Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by Qualigen, Inc. (Carlsbad, US). The FDA issued a Cleared decision on February 18, 2011 after a review of 277 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 Qualigen, Inc. devices

Submission Details

510(k) Number K101388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2010
Decision Date February 18, 2011
Days to Decision 277 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
189d slower than avg
Panel avg: 88d · This submission: 277d
Pathway characteristics
Modification to existing cleared device.

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 54
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K101388.
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K102814 · Roche Diagnostics · Jan 2011
ELECSYS TESTOSTERONE II IMMUNOASSAY
K093421 · Roche Diagnostics Corp. · Apr 2010
ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773
K091867 · Siemens Healthcare Diagnostics · Jan 2010