Cleared Traditional

K182521 - FastPack IP Sex Hormone Binding Globulin Immunoassay

K182521 is an FDA 510(k) clearance for FastPack IP Sex Hormone Binding Globuli..., manufactured by Qualigen, Inc.. The device is a Class 1 Chemistry device with product code CDZ cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K182521 · Qualigen, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Qualigen, Inc. devices

FDA 510(k) Submission Details - K182521

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 88d · This submission: 138d
Pathway characteristics
Predicate-based equivalence.

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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K153577 · Nanoentek USA, Inc. · Oct 2016
ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material
K151986 · Siemens Healthcare Diagnostics, Inc. · Jun 2016