Cleared Traditional

K874873 - COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1

K874873 is an FDA 510(k) clearance for COMBIGENE(TM) ANTI-DNA #KADDZ, manufactured by Diagnostic Products Corp.. The device is a Class 2 Immunology device with product code DHN cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K874873 · Diagnostic Products Corp. · Immunology device
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Feb 1988
Decision
72d
Days
Class 2
Risk

K874873 is an FDA 510(k) clearance for the COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on February 10, 1988 after a review of 72 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 - K874873

510(k) Number K874873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1987
Decision Date February 10, 1988
Days to Decision 72 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
33d faster than avg
Panel avg: 105d · This submission: 72d
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 K874873.
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NOVA LITE(TM) DSDNA
K880742 · Inova Diagnostics, Inc. · Mar 1988
BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM
K872845 · Bion Ent., Ltd. · Aug 1987
ANTI-DNP MICROASSAY
K872560 · Diamedix Corp. · Jul 1987
CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT
K871801 · Cytotech, Inc. · Jun 1987
K874873 · COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1
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