Cleared Traditional

K162606 - Elecsys TSH assay

K162606 is an FDA 510(k) clearance for Elecsys TSH assay, manufactured by Roche Diagnostics. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K162606 · Roche Diagnostics · Chemistry device
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Jan 2017
Decision
126d
Days
Class 2
Risk

K162606 is an FDA 510(k) clearance for the Elecsys TSH assay, cobas e 801 Immunoassay analyzer. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on January 23, 2017 after a review of 126 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.

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FDA 510(k) Submission Details - K162606

510(k) Number K162606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2016
Decision Date January 23, 2017
Days to Decision 126 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
38d slower than avg
Panel avg: 88d · This submission: 126d
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 177
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K162606.
Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
K221225 · Beckman Coulter, Inc. · Nov 2022
Elecsys TSH
K190773 · Roche Diagnostics · Apr 2019
Lumipulse G TSH-III Immunoreaction Cartridges
K171103 · Fujirebio Diagnostics,Inc. · Jul 2017
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