Cleared Traditional

K860183 - AFT-HEP SYSTEM

K860183 is the FDA 510(k) clearance for AFT-HEP SYSTEM by Behring Diagnostics, Inc.. It is a Class 2 Immunology device (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.

View all Behring Diagnostics, Inc. devices

Submission Details

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
68d faster than avg
Panel avg: 104d · This submission: 36d
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 51
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K860183.
COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1
K874873 · Diagnostic Products Corp. · Feb 1988
ANTI-DNP MICROASSAY
K872560 · Diamedix Corp. · Jul 1987
ANTI-DNA MICROASSAY
K863717 · Diamedix Corp. · Oct 1986
COLORZYME NDNA TEST SYSTEM
K843225 · Immuno Concepts, Inc. · Nov 1984
RIANEN ANIT-DOUBLE STRANDED DEOXYRIBON
K843347 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1984
ANA SENSITIVITY/SPECIFICITY CONTROL
K841776 · Behring Diagnostics, Inc. · Jun 1984