Cleared Traditional

K080523 - KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT (FDA 510(k) Clearance)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K080523 · Kronus Market Development Associates, Inc. · Immunology device
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Jun 2008
Decision
112d
Days
Class 2
Risk

K080523 is an FDA 510(k) clearance for the KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT. Classified as Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-blocking (product code NST), Class II - Special Controls.

Submitted by Kronus Market Development Associates, Inc. (Boise, US). The FDA issued a Cleared decision on June 17, 2008 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - 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.

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Submission Details

510(k) Number K080523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2008
Decision Date June 17, 2008
Days to Decision 112 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 104d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NST Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-blocking
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
Definition The Device Is An Immunoassay Indicated As An Aid In The Diagnosis Of Myasthenia Gravis, An Autoimmune Disease Characterized By Exercise-induced Muscle Weakness Temporarily Relieved By Cessation Of Exercise. Autoantibody, When Present In Serum, Interferes With The Binding Of Acetylcholine, A Neural Transmitter At The Junction Of Nerves With Muscles. Autoantibody Can Also Bind To Other Portions Of The Acetylcholine Receptor Without Interfering With Acetylcholine Binding. Presence Of Autoantibody Along With Clinical Signs And Symptoms Are Usually Highly Suggestive Of Myasthenia Gravis. Acetylcholine Receptor Autoantibody Can Also Occur In The Presence Of Autoantibodies To Other Body Substances.
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.