Cleared Special

K003094 - FASTPACK PSA IMMUNOASSAY

K003094 is the FDA 510(k) clearance for FASTPACK PSA IMMUNOASSAY by Qualigen, Inc.. It is a Class 2 Immunology device (product code LTJ) cleared through the Special 510(k) pathway after a 22-day FDA review.

K003094 · Qualigen, Inc. · Immunology device
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Oct 2000
Decision
22d
Days
Class 2
Risk

K003094 is an FDA 510(k) clearance for the FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER. Classified as Prostate-specific Antigen (psa) For Management Of Prostate Cancers (product code LTJ), Class II - Special Controls.

Submitted by Qualigen, Inc. (Carlsbad, US). The FDA issued a Cleared decision on October 25, 2000 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - the FDA immunology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Qualigen, Inc. devices

Submission Details

510(k) Number K003094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2000
Decision Date October 25, 2000
Days to Decision 22 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 104d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LTJ Prostate-specific Antigen (psa) For Management Of Prostate Cancers
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
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 - LTJ Prostate-specific Antigen (psa) For Management Of Prostate Cancers

All 23
Devices cleared under the same product code (LTJ) and FDA review panel - the closest regulatory comparables to K003094.
VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428
K010550 · bioMerieux, Inc. · Apr 2001
DIMENSION PSA FLEX REAGENT CARTRIDGE
K003963 · Dade Behring, Inc. · Feb 2001
ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY
K002376 · Bayer Corp. · Oct 2000
BAYER PSA ASSAY
K994221 · Bayer Corp. · Apr 2000
MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS
K000566 · Ortho-Clinical Diagnostics, Inc. · Mar 2000
VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK
K984289 · Ortho-Clinical Diagnostics, Inc. · Mar 1999