Cleared Traditional

K142362 - Access 25(OH) Vitamin D Total for Use o...

K142362 is the FDA 510(k) clearance for Access 25(OH) Vitamin D Total for Use o... by Beckman Coulter, Inc.. It is a Class 2 Chemistry device (product code MRG) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K142362 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
116d
Days
Class 2
Risk

K142362 is an FDA 510(k) clearance for the Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access .... Classified as System, Test, Vitamin D (product code MRG), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on December 19, 2014 after a review of 116 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 Beckman Coulter, Inc. devices

Submission Details

510(k) Number K142362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2014
Decision Date December 19, 2014
Days to Decision 116 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
28d slower than avg
Panel avg: 88d · This submission: 116d
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 22
Devices cleared under the same product code (MRG) and FDA review panel - the closest regulatory comparables to K142362.
Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5
K162840 · Roche Diagnostics · Feb 2017
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
Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst
K142373 · Beckman Coulter, Inc. · Dec 2014
LIASON XL1,25 DIHYDROXYVITAMIN D
K141463 · DiaSorin, Inc. · Dec 2014
ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY
K133156 · Siemens Healthcare Diagnostics, Inc. · Jul 2014
LIAISON 25 TOTAL-D
K132492 · DiaSorin, Inc. · Sep 2013