Cleared Abbreviated

K003096 - FASTPACK CALIBRATORS (FDA 510(k) Clearance)

Class II Immunology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K003096 · Qualigen, Inc. · Immunology device
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.

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
Regulatory Context
Review time vs. panel average
219d faster than avg
Panel avg: 277d · 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.