Cleared Traditional

K153361 - Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators

K153361 is an FDA 510(k) clearance for Lumipulse G 25-OH Vitamin D, manufactured by Fujirebio Diagnostics,Inc.. The device is a Class 2 Chemistry device with product code MRG cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K153361 · Fujirebio Diagnostics,Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
147d
Days
Class 2
Risk

K153361 is an FDA 510(k) clearance for the Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators. Classified as System, Test, Vitamin D (product code MRG), Class II - Special Controls.

Submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on April 15, 2016 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1825 - 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 - K153361

510(k) Number K153361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2015
Decision Date April 15, 2016
Days to Decision 147 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
59d slower than avg
Panel avg: 88d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRG Device Classification - Class 2, Special Controls

Product Code MRG System, Test, Vitamin D
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1825
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 - MRG System, Test, Vitamin D

All 42
Devices cleared under the same product code (MRG) and FDA review panel - the closest regulatory comparables to K153361.
Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5
K162840 · Roche Diagnostics · Feb 2017
IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set
K161831 · Immunodiagnostic Systems , Ltd. · Nov 2016
ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls
K153375 · Abbott Laboratories · Aug 2016
ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set
K150270 · Tosoh Bioscience, Inc. · Oct 2015
25-Hydroxy Vitamin Ds EIA
K142351 · Immunodiagnostic Systems , Ltd. · Aug 2015
BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D
K141114 · Bio-Rad Laboratories · Jan 2015