Cleared Traditional

K151792 - Trinidad IM Thyroid Stimulating Hormone...

K151792 is an FDA 510(k) clearance for Trinidad IM Thyroid Stimulating Hormone..., manufactured by Siemens Healthcare Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K151792 · Siemens Healthcare Diagnostics, Inc. · Chemistry device
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Nov 2015
Decision
142d
Days
Class 2
Risk

K151792 is an FDA 510(k) clearance for the Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrat.... Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on November 20, 2015 after a review of 142 days - within the typical 510(k) review window.

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 Siemens Healthcare Diagnostics, Inc. devices

FDA 510(k) Submission Details - K151792

510(k) Number K151792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2015
Decision Date November 20, 2015
Days to Decision 142 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
54d slower than avg
Panel avg: 88d · This submission: 142d
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 169
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K151792.
Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control
K160541 · Sysmex America, Inc. · Oct 2016
Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems
K153651 · Beckman Coulter, Inc. · Aug 2016
IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4
K160647 · Siemens Healthcare Diagnostics, Inc. · May 2016
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