Cleared Traditional

K860183 - AFT-HEP SYSTEM

K860183 is an FDA 510(k) clearance for AFT-HEP SYSTEM, manufactured by Behring Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DHN cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K860183 · Behring Diagnostics, Inc. · Immunology device
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Feb 1986
Decision
36d
Days
Class 2
Risk

K860183 is an FDA 510(k) clearance for the AFT-HEP SYSTEM. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (La Jolla, US). The FDA issued a Cleared decision on February 26, 1986 after a review of 36 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 - K860183

510(k) Number K860183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1986
Decision Date February 26, 1986
Days to Decision 36 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
69d faster than avg
Panel avg: 105d · This submission: 36d
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 K860183.
RAT LIVER NUCLEI TEST SYSTEM
K870732 · Val Tech Diagnostics, Inc. · Mar 1987
ANTI-DNA MICROASSAY
K863717 · Diamedix Corp. · Oct 1986
CAPPEL DIAGNOSTICS ANA KIT
K862821 · Cappel Diagnostics, Inc. · Aug 1986
FANA 60
K854314 · American Bio-Reagents, Inc. · Dec 1985
SS-A(RO) & SS-B(LA) ANTIBODY ASSAY
K852033 · Meloy Laboratories, Inc. · Jun 1985
ANTINUCLEAR ANTIBODY TEST KIT
K851369 · Modern Diagnostics, Inc. · May 1985
K860183 · AFT-HEP SYSTEM
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