Cleared Traditional

K152422 - FREND™ Free T4 Test System (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K152422 · Nanoentek USA, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
175d
Days
Class 2
Risk

K152422 is an FDA 510(k) clearance for the FREND™ Free T4 Test System. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Nanoentek USA, Inc. (Pleasanton, US). The FDA issued a Cleared decision on February 17, 2016 after a review of 175 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1695 - 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 Nanoentek USA, Inc. devices

Submission Details

510(k) Number K152422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2015
Decision Date February 17, 2016
Days to Decision 175 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
87d slower than avg
Panel avg: 88d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEC Radioimmunoassay, Free Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1695
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.