Cleared Traditional

K131928 - FREND TSH (REAGENT CARTRIDGE)

K131928 is an FDA 510(k) clearance for FREND TSH (REAGENT CARTRIDGE), manufactured by Nanoentek USA, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K131928

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
Combination Product No
PCCP Authorized No
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.

JLW Device Classification - Class 2, Special Controls

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 199
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
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LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3
K130469 · DiaSorin, Inc. · Apr 2013
MICT TSH
K110761 · Magnabiosciences, LLC · Mar 2012
GSP INSTRUMENT AND GSP NEONATAL HTSH KIT
K090846 · Perkinelmer, Inc. · Sep 2009