Cleared Abbreviated

K022533 - FASTPACK TESTOSTERONE CALIBRATOR (FDA 510(k) Clearance)

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

K022533 · Qualigen, Inc. · Chemistry device
Sep 2002
Decision
61d
Days
Class 2
Risk

K022533 is an FDA 510(k) clearance for the FASTPACK TESTOSTERONE CALIBRATOR. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Qualigen, Inc. (Carlsbad, US). The FDA issued a Cleared decision on September 30, 2002 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - the FDA in vitro diagnostics and chemistry 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 K022533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2002
Decision Date September 30, 2002
Days to Decision 61 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
173d faster than avg
Panel avg: 234d · This submission: 61d
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 Chemistry devices follow this clearance model.