Cleared Traditional

EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM (K100017) - FDA 510(k) Clearance

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

K100017 · Euroimmun Us, Inc. · Immunology device
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Sep 2010
Decision
252d
Days
Class 2
Risk

K100017 is an FDA 510(k) clearance for the EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST S.... Classified as Anti-glutamate Receptor (type Nmda) Ifa (product code OSK), Class II - Special Controls.

Submitted by Euroimmun Us, Inc. (Morristown, US). The FDA issued a Cleared decision on September 13, 2010 after a review of 252 days - an extended review cycle.

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.

View all Euroimmun Us, Inc. devices

Submission Details

510(k) Number K100017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2010
Decision Date September 13, 2010
Days to Decision 252 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 104d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OSK Anti-glutamate Receptor (type Nmda) Ifa
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
Definition Intended For The Qualitative Determination Of Autoantibodies Against Glutamate Receptor (type Nmda) In Human Serum. Used As An Aid In The Diagnosis Of Anti-glutamate Receptor (type Nmda) Autoimmune Encephalitis In Conjunction With Other Laboratory And Clinical Findings.
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.