Cleared Traditional

K153145 - Lumipulse G TP-N Immunoreaction Cartridge Set

K153145 is an FDA 510(k) clearance for Lumipulse G TP-N Immunoreaction Cartrid..., manufactured by Fujirebio Diagnostics,Inc.. The device is a Class 2 Microbiology device with product code LIP cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K153145 · Fujirebio Diagnostics,Inc. · Microbiology device
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Jul 2016
Decision
249d
Days
Class 2
Risk

K153145 is an FDA 510(k) clearance for the Lumipulse G TP-N Immunoreaction Cartridge Set. Classified as Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (product code LIP), Class II - Special Controls.

Submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on July 5, 2016 after a review of 249 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3830 - the FDA microbiology device 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fujirebio Diagnostics,Inc. devices

FDA 510(k) Submission Details - K153145

510(k) Number K153145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2015
Decision Date July 05, 2016
Days to Decision 249 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 102d · This submission: 249d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIP Device Classification - Class 2, Special Controls

Product Code LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3830
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 Microbiology devices follow this clearance model.

Regulatory Peers - LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

All 24
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