Cleared Traditional

K182521 - FastPack IP Sex Hormone Binding Globulin Immunoassay (FDA 510(k) Clearance)

Class I Chemistry device.

K182521 · Qualigen, Inc. · Chemistry device
Jan 2019
Decision
138d
Days
Class 1
Risk

K182521 is an FDA 510(k) clearance for the FastPack IP Sex Hormone Binding Globulin 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 January 29, 2019 after a review of 138 days - within the typical 510(k) review window.

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.

Submission Details

510(k) Number K182521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2018
Decision Date January 29, 2019
Days to Decision 138 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 234d · This submission: 138d
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.