Cleared Traditional

K131928 - FREND TSH (REAGENT CARTRIDGE)

K131928 is the FDA 510(k) clearance for FREND TSH (REAGENT CARTRIDGE) by Nanoentek USA, Inc.. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K131928 · Nanoentek USA, Inc. · Chemistry device
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Mar 2014
Decision
260d
Days
Class 2
Risk

K131928 is an FDA 510(k) clearance for the FREND TSH (REAGENT CARTRIDGE). Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Nanoentek USA, Inc. (Oxford, US). The FDA issued a Cleared decision on March 14, 2014 after a review of 260 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1690 - 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 K131928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2013
Decision Date March 14, 2014
Days to Decision 260 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
172d slower than avg
Panel avg: 88d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JLW Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1690
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.

Regulatory Peers - JLW Radioimmunoassay, Thyroid-stimulating Hormone

All 144
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K131928.
Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System
K151792 · Siemens Healthcare Diagnostics, Inc. · Nov 2015
ADVIA Centaur TSH3-Ultra
K150403 · Siemens Healthcare Diagnostics, Inc. · May 2015
ADVIA CENTAUR TSH
K141999 · Siemens Healthcare Diagnostics, Inc. · Apr 2015
LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3
K130469 · DiaSorin, Inc. · Apr 2013
ADVIA CENTAUR TSH3-ULTRA METHOD
K083844 · Siemens Healthcare Diagnostics · May 2009
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM
K083173 · Ortho-Clinical Diagnostics · Dec 2008