Cleared Traditional

K123983 - FASTPACK VITAMIN D

Also marketed or referenced as:
IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS

K123983 is the FDA 510(k) clearance for FASTPACK VITAMIN D by Qualigen, Inc.. It is a Class 2 Chemistry device (product code MRG) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K123983 · Qualigen, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
189d
Days
Class 2
Risk

K123983 is an FDA 510(k) clearance for the FASTPACK VITAMIN D. Classified as System, Test, Vitamin D (product code MRG), Class II - Special Controls.

Submitted by Qualigen, Inc. (Carlsbad, US). The FDA issued a Cleared decision on July 3, 2013 after a review of 189 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 Qualigen, Inc. devices

Submission Details

510(k) Number K123983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2012
Decision Date July 03, 2013
Days to Decision 189 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
101d slower than avg
Panel avg: 88d · This submission: 189d
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 29
Devices cleared under the same product code (MRG) and FDA review panel - the closest regulatory comparables to K123983.
ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY
K133156 · Siemens Healthcare Diagnostics, Inc. · Jul 2014
DIAZYME 25-OH VITAMIN D ASSAY
K133410 · Diazyme Laboratories · Mar 2014
LIAISON 25 TOTAL-D
K132492 · DiaSorin, Inc. · Sep 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