Cleared Traditional

K871994 - ENA III TEST KIT (SCL-70 AUTOANTIBODY R...

K871994 is the FDA 510(k) clearance for ENA III TEST KIT (SCL-70 AUTOANTIBODY R... by Behring Diagnostics, Inc.. It is a Class 2 Immunology device (product code LLL) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K871994 · Behring Diagnostics, Inc. · Immunology device
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Aug 1987
Decision
78d
Days
Class 2
Risk

K871994 is an FDA 510(k) clearance for the ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS). 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 August 12, 1987 after a review of 78 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 K871994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1987
Decision Date August 12, 1987
Days to Decision 78 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
26d faster than avg
Panel avg: 104d · This submission: 78d
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 K871994.
NOVA GEL(TM) SM/RNP
K881181 · Inova Diagnostics, Inc. · Apr 1988
NOVA LITE(TM) ANA
K880736 · Inova Diagnostics, Inc. · Mar 1988
NOVA GEL(TM) SS-A/SS-B
K880896 · Inova Diagnostics, Inc. · Mar 1988
SERATEST ENA [SS-B] KIT
K862700 · Hemagen Diagnostics, Inc. · Aug 1986
KALLESTAD SSA/SSB ENA TEST REAGENTS
K862710 · Kallestad Laboratories, Inc. · Jul 1986
SM-RNP AUTOANTIBODY TEST SYSTEM
K860428 · Immuno Concepts, Inc. · May 1986