Cleared Traditional

K141114 - BIOPLEX 2200 25-OH VITAMIN D KIT

K141114 is the FDA 510(k) clearance for BIOPLEX 2200 25-OH VITAMIN D KIT by Bio-Rad Laboratories. It is a Class 2 Chemistry device (product code MRG) cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K141114 · Bio-Rad Laboratories · Chemistry device
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Jan 2015
Decision
254d
Days
Class 2
Risk

K141114 is an FDA 510(k) clearance for the BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRAT.... Classified as System, Test, Vitamin D (product code MRG), Class II - Special Controls.

Submitted by Bio-Rad Laboratories (Benicia, US). The FDA issued a Cleared decision on January 9, 2015 after a review of 254 days - an extended review cycle.

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 Bio-Rad Laboratories devices

Submission Details

510(k) Number K141114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2014
Decision Date January 09, 2015
Days to Decision 254 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
166d slower than avg
Panel avg: 88d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 24
Devices cleared under the same product code (MRG) and FDA review panel - the closest regulatory comparables to K141114.
LOCI Total Vitamin D Total Assay, LOCI VITD CAL
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ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls
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Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno.
K142362 · Beckman Coulter, Inc. · Dec 2014
LIASON XL1,25 DIHYDROXYVITAMIN D
K141463 · DiaSorin, Inc. · Dec 2014