Cleared Traditional

K001398 - REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT

K001398 is an FDA 510(k) clearance for REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTI..., manufactured by Corgenix, Inc.. The device is a Class 2 Immunology device with product code DHC cleared through the Traditional 510(k) pathway after a 331-day FDA review.

K001398 · Corgenix, Inc. · Immunology device
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Mar 2001
Decision
331d
Days
Class 2
Risk

K001398 is an FDA 510(k) clearance for the REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT. Classified as System, Test, Systemic Lupus Erythematosus (product code DHC), Class II - Special Controls.

Submitted by Corgenix, Inc. (Westminster, US). The FDA issued a Cleared decision on March 30, 2001 after a review of 331 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5820 - the FDA immunology 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Corgenix, Inc. devices

FDA 510(k) Submission Details - K001398

510(k) Number K001398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2000
Decision Date March 30, 2001
Days to Decision 331 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
226d slower than avg
Panel avg: 105d · This submission: 331d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHC Device Classification - Class 2, Special Controls

Product Code DHC System, Test, Systemic Lupus Erythematosus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5820
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 - DHC System, Test, Systemic Lupus Erythematosus

All 11
Devices cleared under the same product code (DHC) and FDA review panel - the closest regulatory comparables to K001398.
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K914801 · General Biometrics, Inc. · Dec 1991
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K821385 · Texas Immunology, Inc. · May 1982
SLE ANTI-N-DNA LATEX TEST
K810226 · Icl Scientific · Feb 1981