Cleared Abbreviated

K003096 - FASTPACK CALIBRATORS

K003096 is the FDA 510(k) clearance for FASTPACK CALIBRATORS by Qualigen, Inc.. It is a Class 2 Immunology device (product code JIT) cleared through the Abbreviated 510(k) pathway after a 58-day FDA review.

K003096 · Qualigen, Inc. · Immunology device
Download Printable Device Report (PDF)
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Nov 2000
Decision
58d
Days
Class 2
Risk

K003096 is an FDA 510(k) clearance for the FASTPACK CALIBRATORS. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Qualigen, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 30, 2000 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1150 - 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 K003096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2000
Decision Date November 30, 2000
Days to Decision 58 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
46d faster than avg
Panel avg: 104d · This submission: 58d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code JIT Calibrator, Secondary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 Immunology devices follow this clearance model.

Regulatory Peers - JIT Calibrator, Secondary

All 160
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K003096.
ELECSYS TESTOSTERONE CALSET II
K003411 · Roche Diagnostics Corp. · Mar 2001
DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137
K010208 · Dade Behring, Inc. · Feb 2001
ELECSYS FSH CALSET II
K003409 · Roche Diagnostics Corp. · Jan 2001
ACCESS ULTRASENSITIVE HGH CALIBRATORS
K003098 · Beckman Coulter, Inc. · Nov 2000
DIMENSION SPECIAL PROTEIN CALIBRATOR
K994291 · Dade Behring, Inc. · Mar 2000
ELECSYS ESTRADIOL CALSET II
K992981 · Roche Diagnostics Corp. · Sep 1999