Cleared Traditional

K013169 - IMMUNE CELL FUNCTION ASSAY

K013169 is an FDA 510(k) clearance for IMMUNE CELL FUNCTION ASSAY, manufactured by Cylex, Inc.. The device is a Class 2 Hematology device with product code NID cleared through the Traditional 510(k) pathway after a 193-day FDA review.

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

FDA 510(k) Submission Details - K013169

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.

NID Device Classification - Class 2, Special Controls

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.