Cleared Traditional

K854314 - FANA 60

K854314 is the FDA 510(k) clearance for FANA 60 by American Bio-Reagents, Inc.. It is a Class 2 Immunology device (product code DHN) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K854314 · American Bio-Reagents, Inc. · Immunology device
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Dec 1985
Decision
49d
Days
Class 2
Risk

K854314 is an FDA 510(k) clearance for the FANA 60. Classified as Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (product code DHN), Class II - Special Controls.

Submitted by American Bio-Reagents, Inc. (Easton, US). The FDA issued a Cleared decision on December 16, 1985 after a review of 49 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 American Bio-Reagents, Inc. devices

Submission Details

510(k) Number K854314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1985
Decision Date December 16, 1985
Days to Decision 49 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 104d · This submission: 49d
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 54
Devices cleared under the same product code (DHN) and FDA review panel - the closest regulatory comparables to K854314.
ANTI-DNP MICROASSAY
K872560 · Diamedix Corp. · Jul 1987
ANTI-DNA MICROASSAY
K863717 · Diamedix Corp. · Oct 1986
AFT-HEP SYSTEM
K860183 · Behring Diagnostics, Inc. · Feb 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