Cleared Traditional

K171103 - Lumipulse G TSH-III Immunoreaction Cartridges

K171103 is an FDA 510(k) clearance for Lumipulse G TSH-III Immunoreaction Cart..., manufactured by Fujirebio Diagnostics,Inc.. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K171103 · Fujirebio Diagnostics,Inc. · Chemistry device
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Jul 2017
Decision
106d
Days
Class 2
Risk

K171103 is an FDA 510(k) clearance for the Lumipulse G TSH-III Immunoreaction Cartridges. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on July 28, 2017 after a review of 106 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 Fujirebio Diagnostics,Inc. devices

FDA 510(k) Submission Details - K171103

510(k) Number K171103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2017
Decision Date July 28, 2017
Days to Decision 106 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
18d slower than avg
Panel avg: 88d · This submission: 106d
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
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