Cleared Abbreviated

K163544 - Lumipulse G Prolactin

K163544 is the FDA 510(k) clearance for Lumipulse G Prolactin by Fujirebio Diagnostics,Inc.. It is a Class 2 Chemistry device (product code JIT) cleared through the Abbreviated 510(k) pathway after a 27-day FDA review.

K163544 · Fujirebio Diagnostics,Inc. · Chemistry device
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Jan 2017
Decision
27d
Days
Class 2
Risk

K163544 is an FDA 510(k) clearance for the Lumipulse G Prolactin. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on January 12, 2017 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - the FDA in vitro diagnostics and chemistry framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Fujirebio Diagnostics,Inc. devices

Submission Details

510(k) Number K163544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2016
Decision Date January 12, 2017
Days to Decision 27 days
Submission Type Abbreviated
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
61d faster than avg
Panel avg: 88d · This submission: 27d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code JIT Calibrator, Secondary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIT Calibrator, Secondary

All 150
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