Cleared Traditional

K123983 - FASTPACK VITAMIN D (FDA 510(k) Clearance)

Also includes:
IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K123983 · Qualigen, Inc. · Chemistry device
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.

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
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 234d · 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.