Cleared Traditional

K182521 - FastPack IP Sex Hormone Binding Globuli...

K182521 is the FDA 510(k) clearance for FastPack IP Sex Hormone Binding Globuli... by Qualigen, Inc.. It is a Class 1 Chemistry device (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

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
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.

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 53
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K182521.
ACTIVE® Free Testosterone RIA
K191350 · Immunotech S.R.O. · Dec 2019
ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG
K191533 · Siemens Healthcare Diagnostics, Inc. · Aug 2019
IDS SHBG
K190121 · Immunodiagnostic Systems , Ltd. · Jun 2019
Free Testosterone AccuBind ELISA Test System
K181017 · Monobind, Inc. · Jul 2018
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
Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator
K151529 · Siemens Healthcare Diagnostics, Inc. · Feb 2016