Cleared Traditional

ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE) (K884400) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K884400 · Immco Diagnostics, Inc. · Immunology device
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Nov 1988
Decision
16d
Days
Class 2
Risk

K884400 is an FDA 510(k) clearance for the ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE). Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on November 4, 1988 after a review of 16 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 Immco Diagnostics, Inc. devices

Submission Details

510(k) Number K884400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1988
Decision Date November 04, 1988
Days to Decision 16 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 104d · This submission: 16d
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 31
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K884400.
NOVA LITE(TM) ANA KSL
K901596 · Inova Diagnostics, Inc. · May 1990
NOVA LITE(TM) ANA MK
K901595 · Inova Diagnostics, Inc. · Apr 1990
ANTINUCLEAR ANTIBODY (ANA) TEST SYSTEM
K897025 · Zeus Scientific, Inc. · Jan 1990
NOVA LITE(TM) DSDNA
K880742 · Inova Diagnostics, Inc. · Mar 1988
COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1
K874873 · Diagnostic Products Corp. · Feb 1988
AFT-HEP SYSTEM
K860183 · Behring Diagnostics, Inc. · Feb 1986