Cleared Special

K101911 - IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY

K101911 is an FDA 510(k) clearance for IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ..., manufactured by Cylex, Inc.. The device is a Class 2 Hematology device with product code NID cleared through the Special 510(k) pathway after a 101-day FDA review.

K101911 · Cylex, Inc. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
101d
Days
Class 2
Risk

K101911 is an FDA 510(k) clearance for the IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION 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 October 18, 2010 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K101911

510(k) Number K101911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2010
Decision Date October 18, 2010
Days to Decision 101 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 113d · This submission: 101d
Pathway characteristics
Modification to existing cleared device.

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.

K101911 · IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY
Download PDF FDA Summary Cylex, Inc.