Cleared Traditional

K871801 - CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT

K871801 is an FDA 510(k) clearance for CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT, manufactured by Cytotech, Inc.. The device is a Class 2 Immunology device with product code DHN cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K871801 · Cytotech, Inc. · Immunology device
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Jun 1987
Decision
32d
Days
Class 2
Risk

K871801 is an FDA 510(k) clearance for the CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Cytotech, Inc. (San Diego, US). The FDA issued a Cleared decision on June 9, 1987 after a review of 32 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 - K871801

510(k) Number K871801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1987
Decision Date June 09, 1987
Days to Decision 32 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
73d faster than avg
Panel avg: 105d · This submission: 32d
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 109
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K871801.
COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1
K874873 · Diagnostic Products Corp. · Feb 1988
BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM
K872845 · Bion Ent., Ltd. · Aug 1987
ANTI-DNP MICROASSAY
K872560 · Diamedix Corp. · Jul 1987
TANGENT SYSTEM(TM) ANA PROFILE TEST KIT
K871144 · Vitrotec Laboratories, Inc. · Apr 1987
DUAL SUBSTRATE ANA
K871395 · Val Tech Diagnostics, Inc. · Apr 1987
HISTONES EIA DIAGNOSTIC KIT
K870458 · Biohytech International, Inc. · Mar 1987
K871801 · CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT
Download PDF Cytotech, Inc.