Cleared Traditional

K860428 - SM-RNP AUTOANTIBODY TEST SYSTEM

K860428 is an FDA 510(k) clearance for SM-RNP AUTOANTIBODY TEST SYSTEM, manufactured by Immuno Concepts, Inc.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K860428

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
5d faster than avg
Panel avg: 105d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLL Device Classification - Class 2, Special Controls

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 147
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
SERATEST ENA(RNP/SM) DETERMINATION
K844743 · Seragen Diagnostics, Inc. · Feb 1985