IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY

K101911 · Cylex, Inc. · NID · Oct 18, 2010 · Hematology

Device Facts

• Record ID: K101911
• Device Name: IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY
• Applicant: Cylex, Inc.
• Product Code: NID · Hematology
• Decision Date: Oct 18, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Indications for Use

The Cylex ImmuKnow Immune Cell function assay is an in vitro diagnostic test intended for the detection of cell-mediated immunity in populations undergoing immunosuppressive therapy for organ transplant. The assay is intended for use as an aid in assessing the immune status of patients. The ImmuKnow assay is for professional use only.

Device Story

The Cylex Immune Cell Function Assay measures ATP concentration in CD4 cells to assess immune function. Input: heparin anti-coagulated whole blood. Process: blood incubated 15-18 hours with phytohemagglutinin (PHA) stimulant vs. non-stimulated control; CD4 cells immunoselected using anti-CD4 monoclonal antibody-coated magnetic particles; cells lysed to release intracellular ATP; luminescence reagent (luciferin/luciferase) added. Output: light emission measured by luminometer (562 nm), proportional to ATP concentration. Result: ATP concentration (ng/mL) calculated via calibration curve. Used in clinical laboratory settings to monitor immune status in transplant recipients on immunosuppressive therapy; helps clinicians evaluate cell-mediated immune response.

Clinical Evidence

Multi-center study of 122 subjects (44 healthy adults, 78 transplant recipients). Evaluated ATP results (ng/mL) against total CD4 counts. Transplant recipients showed lower mean ATP (274 ng/mL) compared to healthy adults (449 ng/mL). Data provided for immune cell function assay results (≤260 vs >260 ng/mL) and CD4 counts (≤350 vs >350) across both populations.

Technological Characteristics

In vitro diagnostic assay; luminescent reagent component; liquid buffer formulation; storage at 2-8°C. Fundamental scientific technology unchanged from predicate.

Indications for Use

Indicated for the detection of cell-mediated immune response in patients undergoing immunosuppressive therapy for organ transplantation.

Regulatory Classification

Identification

An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”

Predicate Devices

• Cylex ImmuKnow Immune Cell function assay (K013169)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K101911

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. Cylex ImmuKnow Immune Cell function assay K013169
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATIONS, including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This modification was for a change in the Buffer formulation in the luminescent reagent to a liquid form stored at 2-8°C. The handling conditions of the luminescent reagent component in the kit as described in the package insert have been modified accordingly.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and stability testing was provided. Results indicate no substantial change in device performance.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis. (Failure Modes and Effects Analysis)
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied. (Provided)
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review. (Provided)

6. A Truthful and Accurate Statement, a 510(k) Summary and the Indications for Use Enclosure.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.