Cleared Traditional

K153577 - FREND Testosterone Test System

K153577 is the FDA 510(k) clearance for FREND Testosterone Test System by Nanoentek USA, Inc.. It is a Class 1 Chemistry device (product code CDZ) cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K153577 · Nanoentek USA, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
304d
Days
Class 1
Risk

K153577 is an FDA 510(k) clearance for the FREND Testosterone Test System. Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by Nanoentek USA, Inc. (Pleasanton, US). The FDA issued a Cleared decision on October 14, 2016 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Nanoentek USA, Inc. devices

Submission Details

510(k) Number K153577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2015
Decision Date October 14, 2016
Days to Decision 304 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
216d slower than avg
Panel avg: 88d · This submission: 304d
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 54
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K153577.
IDS SHBG
K190121 · Immunodiagnostic Systems , Ltd. · Jun 2019
FastPack IP Sex Hormone Binding Globulin Immunoassay
K182521 · Qualigen, Inc. · Jan 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
ARCHITECT 2nd Generation Testosterone
K152155 · Abbott Laboratories · Dec 2015