Cleared Traditional

IMMUNE CELL FUNCTION ASSAY (K013169) - FDA 510(k) Clearance

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

K013169 · Cylex, Inc. · Hematology device
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Apr 2002
Decision
193d
Days
Class 2
Risk

K013169 is an FDA 510(k) clearance for the IMMUNE CELL FUNCTION ASSAY. Classified as Assay, Proliferation, In Vitro, T Lymphocyte (product code NID), Class II - Special Controls.

Submitted by Cylex, Inc. (Baldwin, US). The FDA issued a Cleared decision on April 2, 2002 after a review of 193 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cylex, Inc. devices

Submission Details

510(k) Number K013169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2001
Decision Date April 02, 2002
Days to Decision 193 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 113d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NID Assay, Proliferation, In Vitro, T Lymphocyte
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
Definition A Device Measuring The Constituents Of Dividing Dna Or Other Pre-division Cellular Constituents To Classify The Ability Of T Lymphocytes (a Type Of Normal White Blood Mononuclear Cell) To Divide Or Proliferate In Response To Specific Or Non-specific Added Stimulants. The T Lymphocytes May Be Normal In Number Or Abnormally Low In Number Due To A Natural Or Induced Immunosuppressed State In The Patient.
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 Hematology devices follow this clearance model.