Cleared Traditional

K843978 - ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTO...

K843978 is the FDA 510(k) clearance for ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTO... by Behring Diagnostics, Inc.. It is a Class 2 Immunology device (product code LLL) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K843978 · Behring Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1984
Decision
68d
Days
Class 2
Risk

K843978 is an FDA 510(k) clearance for the ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (La Jolla, US). The FDA issued a Cleared decision on December 18, 1984 after a review of 68 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 K843978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1984
Decision Date December 18, 1984
Days to Decision 68 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
36d faster than avg
Panel avg: 104d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLL Extractable Antinuclear Antibody, Antigen And 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 - LLL Extractable Antinuclear Antibody, Antigen And Control

All 116
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K843978.
SM-RNP AUTOANTIBODY TEST SYSTEM
K860428 · Immuno Concepts, Inc. · May 1986
SS-A/SS-B AUTOANTIBODY TEST SYSTEM
K860644 · Immuno Concepts, Inc. · Mar 1986
PHYSIO GAS ANALYZER
K843423 · Research Medical, Inc. · Feb 1985
EXTRACTABLE NUCLEAR ANTIGEN ASSAY
K840221 · Zeus Scientific, Inc. · May 1984
ENA TEST KIT SM & RNP AUTO ANTIBODY
K831036 · Calbiochem-Behring Corp. · Apr 1983