Cleared Abbreviated

K003095 - FASTPACK CONTROL

K003095 is the FDA 510(k) clearance for FASTPACK CONTROL by Qualigen, Inc.. It is a Class 1 Immunology device (product code JJX) cleared through the Abbreviated 510(k) pathway after a 57-day FDA review.

K003095 · Qualigen, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
57d
Days
Class 1
Risk

K003095 is an FDA 510(k) clearance for the FASTPACK CONTROL. 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 November 29, 2000 after a review of 57 days - a notably fast clearance 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 K003095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2000
Decision Date November 29, 2000
Days to Decision 57 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
47d faster than avg
Panel avg: 104d · This submission: 57d
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 K003095.
ELECSYS HCG+B CALCHECK
K010237 · Roche Diagnostics Corp. · Feb 2001
CA 125 II CALCHECK
K003967 · Roche Diagnostics Corp. · Jan 2001
ELECSYS DHEA-S CALCHECK
K003772 · Roche Diagnostics Corp. · Dec 2000
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS
K003112 · Ortho-Clinical Diagnostics, Inc. · Nov 2000
BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS
K002540 · Bionostics, Inc. · Sep 2000
SUGAR CHEX ONE
K001443 · Streck Laboratories, Inc. · Jun 2000