(193 days)
No
The description details a biochemical assay measuring ATP concentration and does not mention any AI or ML components for data analysis or interpretation.
No
This device is an in vitro diagnostic assay used for measuring immune cell function, which helps monitor disease or treatment, rather than providing direct therapy.
Yes
The device measures ATP from CD4 cells to detect cell-mediated immune response in populations undergoing immunosuppressive therapy, which is a diagnostic purpose.
No
The device description explicitly mentions the use of physical components like magnetic particles, lysis reagent, and a luminometer, indicating it is a hardware-based assay with associated software for calculation.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device "measures the concentration of ATP from circulating CD4 cells following in vitro stimulation... as an indicator of immune cell function." It also specifies that this measurement is made on "heparin anticoagulated whole blood." This indicates that the test is performed on a biological sample taken from the human body.
- Device Description: The description details the process of performing the assay on "heparin anti-coagulated whole blood" and the steps involved in analyzing the sample to obtain a result.
- Performance Studies: The performance studies were conducted on "freshly drawn blood collected from 44 apparently healthy adults and 78 transplant recipients." This further confirms that the device is used to test human biological samples.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Cylex Immune Cell Function Assay fits this definition perfectly as it analyzes whole blood to assess immune cell function, which is used for monitoring in populations undergoing immunosuppressive therapy.
N/A
Intended Use / Indications for Use
The Cylex Immune Cell Function Assay measures the concentration of ATP from circulating CD4 cells following in vitro stimulation with phytohemagglutinin (PHA) as an indicator of immune cell function. This measurement is made on heparin anti-coagulated whole blood using a luminometer and luciferin/luciferase. The assay is used for the detection of cell mediated immune response in populations undergoing immunosuppressive therapy for organ transplant.
The Cylex Immune Cell Function Assay detects cell-mediated immunity (CMI) by measuring the concentration of ATP from CD4 cells following stimulation. This measurement is made on heparin anti-coagulated whole blood using a luminometer and luciferin/luciferase. The assay is used for the detection of cell-mediated immunity in an immunosuppressed population.
Product codes
NID
Device Description
The Cylex Immune Cell Function Assay measures the concentration of ATP intended Ose. The Gylox filmulation with phytohemagglutinin (PHA) as an indicator of immune cell function. This measurement is made on heparin anti-coagulated whole Indicator of inindile cell function: "This models on the assay is used for the detection of cell blood dailing a luminoneter and lablem. Include going immunosuppressive therapy for organ transplant.
The Cylex Immune Cell Function Assay detects cell-mediated immunity in Test Description: The Oylex Mininens Collinitians Colling incubation, increased ATP writhesis occurs within the cells that respond to the stimulant phytohemagglutinin (PHA). synthesis occurs whall the oblished in the absence of stimulant for the purpose of assessing Concarrently, whole blood to mouslanal antibody coated magnetic particles are added to immunoselect CD4 cells from both the stimulated and non-stimulated wells. After washing the selected CD4 cells on a magnet tray, Lysis Reagent is added to release intracellular ATP. selected CD4 cells of a magnet tray, byels nought the released ATP produces light according to the following equation:
Mo Oxyluciferin +AMP +Pyrophosphate +CO2 + Light Luciferin +ATP +O2 Luciferase
The amount of light measured by a luminometer (emission maximum 562 nm) is propritional to The amount of light meadrou by a lantration of ATP. The concerners to characterize the cellular immune function of the sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults, age range 20-60 years for apparently healthy adults, and 20-64 years for transplant patients.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A multi-center study was conducted on freshly drawn blood collected from 44 apparently healthy adults and 78 transplant recipients (17 at discharge from the hospital and 61 post-discharge follow-up). The samples were evaluated with the Cylex Immune Cell Function Assay.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A multi-center study was conducted on freshly drawn blood collected from 44 apparently healthy adults and 78 transplant recipients (17 at discharge from the hospital and 61 post-discharge follow-up). The samples were evaluated with the Cylex Immune Cell Function Assay. The apparently healthy adult population consisted of 11% (5) females, 86% (38) males and 3% (1) unknown, with an age range of 20 - 60 years. The ethnicity of the population was 80% (35) African American, 16% Caucasian (7), and 4% (2) other or unknown. The transplant population consisted of 33% (26) females and 67% (52) males, with an age range of 20 - 64 years. The ethnicity of the population was 15% (12) African American, 74% Caucasian (58), 10% (8) other or unknown. The organs transplanted were 55% (43) liver, 36% (28) kidney, 4% (3) pancreas, and 5% (4) multiple organs.
For purposes of these calculations, samples with %CV > 20% (after application of the outlier rule) were not included. The means of the two populations were found to be statically different.
Key Results:
Apparently Healthy (Non-immunosuppressed) (n=40):
- Cylex ICF Assay (ATP ng/mL): Mean 464, SD 145, Median 443, Range 243-967
- Comparator Assay CD4 Count by Flow Cytometry (cells/µL): Mean 746, SD 431, Median 654, Range 130-2659
Transplant (immunosuppressed) (n=63):
- Cylex ICF Assay (ATP ng/mL): Mean 304, SD 163, Median 293, Range 58-759
- Comparator Assay CD4 Count by Flow Cytometry (cells/µL): Mean 542, SD 423, Median 503, Range
§ 864.5220 Automated differential cell counter.
(a)
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.(b)
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.”
0
K 013169
APR 0 2 2002
March 21, 2002
510(K) SUMMARY
Cylex Inc. Immune Cell Function Assay
Submitted by:
Cylex Inc. 8980-1 Old Annapolis Road Columbia, MD 21045
Contact:
Dr. Judy Britz
Name of Device:
| Trade Name: | Immune Cell Function Assay |
|---|---|
| Common Name: | CD4 Cell Stimulation Assay |
| Classification Name: | Automated Differential Cell Counter |
| Predicate Device: | Becton Dickinson TriTest™ CD4 FITC/CD8 PE/CD3 |
| PerCP Reagent; | |
| Becton Dickinson MultiTest™ CD3 FITC/CD8 PE/CD4 | |
| PerCP/CD4 APC Reagent |
Device Description:
Device Describitor.
Intended Use: The Cylex Immune Cell Function Assay measures the concentration of ATP intended Ose. The Gylox filmulation with phytohemagglutinin (PHA) as an indicator of immune cell function. This measurement is made on heparin anti-coagulated whole Indicator of inindile cell function: "This models on the assay is used for the detection of cell blood dailing a luminoneter and lablem. Include going immunosuppressive therapy for organ transplant.
Test Description: The Cylex Immune Cell Function Assay detects cell-mediated immunity in Test Description: The Oylex Mininens Collinitians Colling incubation, increased ATP writhesis occurs within the cells that respond to the stimulant phytohemagglutinin (PHA). synthesis occurs whall the oblished in the absence of stimulant for the purpose of assessing Concarrently, whole blood to mouslanal antibody coated magnetic particles are added to immunoselect CD4 cells from both the stimulated and non-stimulated wells. After washing the selected CD4 cells on a magnet tray, Lysis Reagent is added to release intracellular ATP. selected CD4 cells of a magnet tray, byels nought the released ATP produces light according to the following equation:
Mo Oxyluciferin +AMP +Pyrophosphate +CO2 + Light Luciferin +ATP +O2 Luciferase
The amount of light measured by a luminometer (emission maximum 562 nm) is propritional to The amount of light meadrou by a lantration of ATP (ng/mL) is calculated from a calibration the concentration of ATT : The concerners to characterize the cellular immune function of the sample.
1
510(K) SUMMARY
Cylex Inc. Immune Cell Function Assay (cont.)
Substantial Equivalence:
The Cylex Inc. Immune Cell Function Assay has been found to be substantially equivalent to the Becton Dickinson TriTest™ CD4 FITC/CD8 PE/CD3 PerCP Reagent (K971205) and MultiTest™ CD3 FITC/CD8 PE/CD45 PerCP/CD4 ACP Reagent (K974360). All assays differentiate CD4 cells: the Cylex assay determines the responsiveness of those cells and the Becton Dickinson assays count the number of those cells.
A multi-center study was conducted on freshly drawn blood collected from 44 apparently healthy adults and 78 transplant recipients (17 at discharge from the hospital and 61 post-discharge follow-up). The samples were evaluated with the Cylex Immune Cell Function Assay. The apparently healthy adult population consisted of 11% (5) females, 86% (38) males and 3% (1) unknown, with an age range of 20 - 60 years. The ethnicity of the population was 80% (35) African American, 16% Caucasian (7), and 4% (2) other or unknown. The transplant population consisted of 33% (26) females and 67% (52) males, with an age range of 20 - 64 years. The ethnicity of the population was 15% (12) African American, 74% Caucasian (58), 10% (8) other or unknown. The organs transplanted were 55% (43) liver, 36% (28) kidney, 4% (3) pancreas, and 5% (4) multiple organs.
For purposes of these calculations, samples with %CV > 20% (after application of the outlier rule) were not included. The means of the two populations were found to be statically different; the results are summarized in the following table.
| Population | Statistic | Cylex ICF Assay
(ATP ng/mL) | Comparator Assay
CD4 Count by Flow
Cytometry
(cells/µL) |
|----------------------------------------------|-----------------|--------------------------------|------------------------------------------------------------------|
| Apparently Healthy
(Non-immunosuppressed) | n | 40 | 40 |
| | Mean | 464 | 746 |
| | SD | 145 | 431 |
| | Median | 443 | 654 |
| | Range of Values | 243-967 | 130-2659 |
| Transplant
(immunosuppressed) | n | 63 | 63 |
| | Mean | 304 | 542 |
| | SD | 163 | 423 |
| | Median | 293 | 503 |
| | Range of Values | 58-759 |