Cleared Abbreviated

K062957 - FASTPACK TOTAL PSA METHOD VERIFICATION KIT (FDA 510(k) Clearance)

Class I Immunology device.

K062957 · Qualigen, Inc. · Immunology device
Apr 2007
Decision
185d
Days
Class 1
Risk

K062957 is an FDA 510(k) clearance for the FASTPACK TOTAL PSA METHOD VERIFICATION KIT. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Qualigen, Inc. (Carlsbad, US). The FDA issued a Cleared decision on April 2, 2007 after a review of 185 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - the FDA immunology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

Submission Details

510(k) Number K062957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2006
Decision Date April 02, 2007
Days to Decision 185 days
Submission Type Abbreviated
Review Panel Immunology (IM)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 277d · This submission: 185d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.