Cleared Traditional

K994424 - DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM

K994424 is the FDA 510(k) clearance for DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM by Diamedix Corp.. It is a Class 2 Immunology device (product code LRM) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K994424 · Diamedix Corp. · Immunology device
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Optimized for regulatory review, auditing and printing
Feb 2000
Decision
50d
Days
Class 2
Risk

K994424 is an FDA 510(k) clearance for the DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM. Classified as Anti-dna Antibody (enzyme-labeled), Antigen, Control (product code LRM), Class II - Special Controls.

Submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on February 18, 2000 after a review of 50 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 Diamedix Corp. devices

Submission Details

510(k) Number K994424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1999
Decision Date February 18, 2000
Days to Decision 50 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
54d faster than avg
Panel avg: 104d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LRM Anti-dna Antibody (enzyme-labeled), Antigen, Control
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 - LRM Anti-dna Antibody (enzyme-labeled), Antigen, Control

All 12
Devices cleared under the same product code (LRM) and FDA review panel - the closest regulatory comparables to K994424.
IMMULISA DSDNA ANTIBODY ELISA
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K993727 · The Binding Site, Ltd. · Dec 1999
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K984396 · Bio-Rad · Dec 1998
THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET
K983422 · Zeus Scientific, Inc. · Nov 1998
IS-DSDNA TEST SYSTEM
K974694 · Diamedix Corp. · Mar 1998