Cleared Abbreviated

K022533 - FASTPACK TESTOSTERONE CALIBRATOR

K022533 is the FDA 510(k) clearance for FASTPACK TESTOSTERONE CALIBRATOR by Qualigen, Inc.. It is a Class 2 Chemistry device (product code JIT) cleared through the Abbreviated 510(k) pathway after a 61-day FDA review.

K022533 · Qualigen, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Qualigen, Inc. devices

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 88d · 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.

Regulatory Peers - JIT Calibrator, Secondary

All 160
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ACCESS UNCONJUGATED ESTRIOL CALIBRATORS
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