Cleared Traditional

K983914 - REAADS MONOCLONAL FREE PROTEIN S ANTIGE...

K983914 is the FDA 510(k) clearance for REAADS MONOCLONAL FREE PROTEIN S ANTIGE... by Corgenix, Inc.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K983914 · Corgenix, Inc. · Hematology device
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Dec 1998
Decision
48d
Days
Class 2
Risk

K983914 is an FDA 510(k) clearance for the REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Corgenix, Inc. (Westminster, US). The FDA issued a Cleared decision on December 22, 1998 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Corgenix, Inc. devices

Submission Details

510(k) Number K983914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1998
Decision Date December 22, 1998
Days to Decision 48 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 113d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 Hematology devices follow this clearance model.

Regulatory Peers - GGP Test, Qualitative And Quantitative Factor Deficiency

All 127
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K983914.
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