Cleared Traditional

K964165 - MICRO21 WITH NDNA

K964165 is the FDA 510(k) clearance for MICRO21 WITH NDNA by Triangle Biomedical Sciences, Inc.. It is a Class 2 Immunology device (product code DHN) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K964165 · Triangle Biomedical Sciences, Inc. · Immunology device
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Jan 1997
Decision
78d
Days
Class 2
Risk

K964165 is an FDA 510(k) clearance for the MICRO21 WITH NDNA. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Triangle Biomedical Sciences, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on January 3, 1997 after a review of 78 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 Triangle Biomedical Sciences, Inc. devices

Submission Details

510(k) Number K964165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1996
Decision Date January 03, 1997
Days to Decision 78 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 104d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 52
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K964165.
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K962276 · Hemagen Diagnostics, Inc. · Dec 1996
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K950979 · Immuno Concepts, Inc. · Jun 1995
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
K944096 · Immuno Concepts, Inc. · Nov 1994