Cleared Traditional

K994071 - RHIGENE ANA ELISA TEST SYSTEM

K994071 is an FDA 510(k) clearance for RHIGENE ANA ELISA TEST SYSTEM, manufactured by Rhigene, Inc.. The device is a Class 2 Immunology device with product code LJM cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K994071 · Rhigene, Inc. · Immunology device
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Jan 2000
Decision
47d
Days
Class 2
Risk

K994071 is an FDA 510(k) clearance for the RHIGENE ANA ELISA TEST SYSTEM. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Rhigene, Inc. (Des Plaines, US). The FDA issued a Cleared decision on January 18, 2000 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - 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: 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 Rhigene, Inc. devices

FDA 510(k) Submission Details - K994071

510(k) Number K994071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1999
Decision Date January 18, 2000
Days to Decision 47 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 105d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJM Device Classification - Class 2, Special Controls

Product Code LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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 - LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls

All 77
Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K994071.
EL-ANA PROFILES-2K1
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K000879 · Zeus Scientific, Inc. · May 2000
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K000880 · Zeus Scientific, Inc. · May 2000
MDI SM/RNP TEST
K993635 · Micro Detect, Inc. · Jan 2000
MDI SS-A TEST
K993636 · Micro Detect, Inc. · Jan 2000
VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96
K993108 · Pharmacia & Upjohn Co. · Nov 1999