Cleared Traditional

K860428 - SM-RNP AUTOANTIBODY TEST SYSTEM

K860428 is the FDA 510(k) clearance for SM-RNP AUTOANTIBODY TEST SYSTEM by Immuno Concepts, Inc.. It is a Class 2 Immunology device (product code LLL) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K860428 · Immuno Concepts, Inc. · Immunology device
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May 1986
Decision
100d
Days
Class 2
Risk

K860428 is an FDA 510(k) clearance for the SM-RNP AUTOANTIBODY TEST SYSTEM. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Immuno Concepts, Inc. (Sacramento, US). The FDA issued a Cleared decision on May 15, 1986 after a review of 100 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Immuno Concepts, Inc. devices

Submission Details

510(k) Number K860428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1986
Decision Date May 15, 1986
Days to Decision 100 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
4d faster than avg
Panel avg: 104d · This submission: 100d
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 117
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K860428.
ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS)
K871994 · Behring Diagnostics, Inc. · Aug 1987
SERATEST ENA [SS-B] KIT
K862700 · Hemagen Diagnostics, Inc. · Aug 1986
KALLESTAD SSA/SSB ENA TEST REAGENTS
K862710 · Kallestad Laboratories, Inc. · Jul 1986
SS-A/SS-B AUTOANTIBODY TEST SYSTEM
K860644 · Immuno Concepts, Inc. · Mar 1986
PHYSIO GAS ANALYZER
K843423 · Research Medical, Inc. · Feb 1985
ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY
K843978 · Behring Diagnostics, Inc. · Dec 1984