Cleared Traditional

K123131 - ST AIA-PACK 25-OH VITAMIN D

K123131 is an FDA 510(k) clearance for ST AIA-PACK 25-OH VITAMIN D, manufactured by Tosoh Bioscience, Inc.. The device is a Class 2 Chemistry device with product code MRG cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K123131 · Tosoh Bioscience, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
127d
Days
Class 2
Risk

K123131 is an FDA 510(k) clearance for the ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-.... Classified as System, Test, Vitamin D (product code MRG), Class II - Special Controls.

Submitted by Tosoh Bioscience, Inc. (South San Franciso, US). The FDA issued a Cleared decision on February 8, 2013 after a review of 127 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 Tosoh Bioscience, Inc. devices

FDA 510(k) Submission Details - K123131

510(k) Number K123131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2012
Decision Date February 08, 2013
Days to Decision 127 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 88d · This submission: 127d
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 38
Devices cleared under the same product code (MRG) and FDA review panel - the closest regulatory comparables to K123131.
LIAISON 25 TOTAL-D
K132492 · DiaSorin, Inc. · Sep 2013
IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN D
K123253 · Immunodiagnostic Systems , Ltd. · Jun 2013
VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS
K121608 · Ortho-Clinical Diagnostics, Inc. · Feb 2013
DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA
K122420 · Diazyme Laboratories · Nov 2012
ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5
K113546 · Roche Diagnostics · Jul 2012
LIAISON 25 OH VITAMIN D TOTAL ASSAY
K112725 · DiaSorin, Inc. · Jan 2012