Cleared Traditional

K955603 - RELSIA SS-A/RO & SS/B LA ANTIBODY TEST ...

K955603 is the FDA 510(k) clearance for RELSIA SS-A/RO & SS/B LA ANTIBODY TEST ... by Immuno Concepts, Inc.. It is a Class 2 Immunology device (product code LLL) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K955603 · Immuno Concepts, Inc. · Immunology device
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Apr 1996
Decision
133d
Days
Class 2
Risk

K955603 is an FDA 510(k) clearance for the RELSIA SS-A/RO & SS/B LA ANTIBODY 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 April 19, 1996 after a review of 133 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 K955603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1995
Decision Date April 19, 1996
Days to Decision 133 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 104d · This submission: 133d
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 K955603.
RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM
K963275 · Immuno Concepts, Inc. · Sep 1996
QUANTA LITE ENA 6 ELISA
K961913 · Inova Diagnostics, Inc. · Jul 1996
RELSIA SCL-70 ANTIBODY TEST SYSTEM
K955602 · Immuno Concepts, Inc. · Apr 1996
RELISA SM/RNP ANTIBODY TEST SYSTEM
K955604 · Immuno Concepts, Inc. · Apr 1996
RELISA JO-1 ANTIBODY TEST SYSTEM
K955605 · Immuno Concepts, Inc. · Apr 1996
HYTEC AUTOIMMUNE KITS (SCL-70)
K954894 · Hycor Biomedical, Inc. · Mar 1996