Cleared Abbreviated

K062957 - FASTPACK TOTAL PSA METHOD VERIFICATION KIT

K062957 is the FDA 510(k) clearance for FASTPACK TOTAL PSA METHOD VERIFICATION KIT by Qualigen, Inc.. It is a Class 1 Immunology device (product code JJX) cleared through the Abbreviated 510(k) pathway after a 185-day FDA review.

K062957 · Qualigen, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Qualigen, Inc. devices

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 104d · 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.

Regulatory Peers - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 371
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K062957.
ELECSYS ANTI-TSHR CALCHECK
K080643 · Roche Diagnostics · Aug 2008
GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK
K081403 · Bionostics, Inc. · Jul 2008
ELECSYS PROBNP II CALCHECK
K080147 · Roche Diagnostics Corp. · Feb 2008
PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS
K062972 · Roche Diagnostics Corp. · Oct 2006
OXICOM CONTROL
K053327 · Bionostics, Inc. · Jan 2006
ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK
K053059 · Roche Diagnostics · Nov 2005