Cleared Traditional

K863717 - ANTI-DNA MICROASSAY

K863717 is an FDA 510(k) clearance for ANTI-DNA MICROASSAY, manufactured by Diamedix Corp.. The device is a Class 2 Immunology device with product code DHN cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K863717 · Diamedix Corp. · Immunology device
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Oct 1986
Decision
31d
Days
Class 2
Risk

K863717 is an FDA 510(k) clearance for the ANTI-DNA MICROASSAY. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on October 24, 1986 after a review of 31 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.

FDA 510(k) Submission Details - K863717

510(k) Number K863717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1986
Decision Date October 24, 1986
Days to Decision 31 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 105d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHN Device Classification - Class 2, Special Controls

Product Code DHN Antinuclear Antibody, Indirect Immunofluorescent, 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 - DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

All 95
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K863717.
DUAL SUBSTRATE ANA
K871395 · Val Tech Diagnostics, Inc. · Apr 1987
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RAT LIVER NUCLEI TEST SYSTEM
K870732 · Val Tech Diagnostics, Inc. · Mar 1987
CAPPEL DIAGNOSTICS ANA KIT
K862821 · Cappel Diagnostics, Inc. · Aug 1986
AFT-HEP SYSTEM
K860183 · Behring Diagnostics, Inc. · Feb 1986
COLORZYME NDNA TEST SYSTEM
K843225 · Immuno Concepts, Inc. · Nov 1984
K863717 · ANTI-DNA MICROASSAY
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