(74 days)
CytoStat/Coulter Clone T8-RD1 T4-FITC
CytoStat/Coulter Clone T8-RD-1/T4-FITC
No
The device description and performance studies focus on the chemical reagents and their performance in flow cytometry, with no mention of AI or ML for data analysis or interpretation.
No.
This device is an in vitro diagnostic (IVD) reagent used for analysis of T-cells in blood, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "For In Vitro Diagnostic Use" and describes its purpose in analyzing T-helper/inducer cells and T-cytotoxic/suppressor cells in peripheral blood for immunodeficiency disorders and other pathological conditions. This clearly indicates a diagnostic function.
No
The device description clearly states it is a reagent (purified mouse anti-human CD4 and CD8 conjugated with fluorochromes) in a buffer solution, which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states "For In Vitro Diagnostic Use".
- Purpose: The device is intended for the analysis of T-helper/inducer cells and T-cytotoxic/suppressor cells in peripheral blood using flow cytometry. This analysis is used to aid in the diagnosis and monitoring of conditions like immunodeficiency disorders.
- Sample Type: It is used with peripheral blood specimens, which are biological samples taken from the human body.
- Diagnostic Information: The results obtained from using this device provide information about the patient's immune status, which is used by healthcare professionals for diagnostic purposes.
N/A
Intended Use / Indications for Use
For In Vitro Diagnostic Use
Mouse Anti-Human T-cell, CD4/FITC, MT310 + Mouse Anti-Human T-cell, CD8/RPE,DK25 (DAKO CD4/CD8) has been developed for use in flow cytometry for the analysis of T-helper/inducer cells and T-cytotoxic/suppressor cells. This reagent allows simultaneous detection and quantification of helper/inducer T-cells (CD4+ cells) and cytotoxic/supprossor T-cells (CD8+ cells) in peripheral blood of normal and pathological conditions such as immunodeficiency disorders. It is one component of the suggested monoclonal antibody (MAb) combinations for routine immunophenotyping of lymphocytes in peripheral blood using flow cytometry.
Product codes
GKZ
Device Description
Purified mouse anti-human CD4, CloneMT310, conjugated with fluorescein isothiocyanate, isomer 1 (FITC) + purified mouse anti-human CD8, Clone DK25, conjugated with R-phycoerythrin, present in 0.05M Tris-HCl buffer, pH 7.2, 15 mM NaN3, 0.1M NaCl, stabilized with 1% carrier protein
Subpopulations of lymphocytes may be stained with fluorochrome-conjugated antibody and evaluated in peripheral blood specimens when contaminating red blood cells (RBC's) are lysed prior to flow cytometric analysis. A subpopulation of WBC's are selected for assessment based upon cell morphology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral blood
Indicated Patient Age Range
Not Found
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
Not Found
Summary of Performance Studies
Performance characteristics have been established by clinical evaluation of compared to the individual single reagent predicate devices that quantitatively measure CD4+ and CD8+ T-cells that have been previously cleared by FDA (CytoStat/Coulter Clone T8-RD-1/T4-FITC).
When flow cytometric tests of peripheral blood samples obtained from apparently healthy adults were completed, correlation of CytoStat/CoulterClone T8-RD-1/T4-FITC with DAKO CD4/CD8 approached a direct 1 : 1 comparison for measurement of CD4 + cells. Correlation of CytoSrat/CoulterClone T8-RD-1/T4-FITC with DAKO CD4/CD8 approached a direct 1 : 1 comparison for measurement of CD8 + cells.
Data for the measurement of CD4+ T-cells by DAKO CD4/CD8 reagent compared to CytoStat/CoulterClone T8-RD-1/T4-FITC on peripheral blood samples obtained from apparently healthy adults as well as ill patients gave a correlation greater than 0.98 us nq the whole blood method for flow cytomery. Data for the measurement of CD8+ T-cells by DAKO CD4/CD8 reagent compared to CytoStat/CoulterClone T8-RD-1/T4-FITC gave a correlation greater than 0.98 using the whole blooc method for flow cytometry.
The CD4 antibody clone, MT31(; was clustered at the Second Leukocyte Typing Workshop,Boston , 1984. The CD8 antibody clone, DK25, was clustered at the Third Leukocyte Typing Workshop,Oxford, England, 1986 under another clone designation.
Linearity testing of DAKO CD4/FITC using CEM cells gave the following linear equation: y =4.26% + 0.93x; r = 0.999
Linearity testing of DAKO CD8/FIPE using JM cells gave the following linear equation: y = 0.06% + 1.01x; r = 0.999
In addition, reproducibility of DAKO reagents using replicates (from peripheral blood) run on two different flow cytometers was measured at three concentrations of each antigen. Cross-reactivity of CD4/CD8 with peripheral blood cells (red blood cells, monocytes, granulocytes, lymphocytes, and platelets) was measured.
Key Metrics
Correlation greater than 0.98 (for CD4+ and CD8+ T-cells)
r = 0.999 (for linearity testing of DAKO CD4/FITC)
r = 0.999 (for linearity testing of DAKO CD8/FIPE)
Predicate Device(s)
CytoStat/Coulter Clone T8-RD1 T4-FITC
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
510(k )Sun mary
| Submitter: | DAKO Corporation
6392 Via Real
Carpinteria, CA 93013
(805)566-6655 | MAY 17 1996 |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact: | Gretchen M. Murray, Ph.D., Regulatory Affairs Asst. Manager | |
| Date Summary
Prepared: | December 21, 1995 | |
| Device Name: | Mouse Anti-Human T-cell, CD4/FITC, MT310 +
Mouse Anti-Human T-cell, CD8/RPE,DK25 | |
| Device
Classification: | Class II according to 21 CFR 864.5220, on the basis that monoclonal antibodies
are accessories for automated cifferential cell counters. | |
| Panel: | This device classification is uncer the Hematology and Pathology devices panel,
Division of Clinical Laboratory Cevices. | |
| Product Code: | GKZ | |
| Predicate Device(s): | CytoStat/Coulter Clone T8-RD1 T4-FITC | |
| Device Description: | Purified mouse anti-human CD4, CloneMT310, conjugated with fluorescein
isothiocyanate, isomer 1 (FITC) + purified mouse anti-human CD8, Clone DK25,
conjugated with R-phycoerythrin, present in 0.05M Tris-HCl buffer, pH 7.2, 15
mM NaN3, 0.1M NaCl, stabilized with 1% carrier protein | |
| | Subpopulations of lymphocytes may be stained with fluorochrome-conjugated
antibody and evaluated in peripheral blood specimens when contaminating red
blood cells (RBC's) are lysed prior to flow cytometric analysis. A subpopulation
of WBC's are selected for assessment based upon cell morphology. | |
| Intended Use: | For In Vitro Diagnostic Use | |
| | Mouse Anti-Human T-cell, CD4/FITC, MT310 + Mouse Anti-Human T-cell,
CD8/RPE,DK25 (DAKO CD4/CD8) has been developed for use in flow
cytometry for the analysis of T-helper/inducer cells and T-cytotoxic/suppressor
cells. This reagent allows simultaneous detection and quantification of
helper/inducer T-cells (CD4+ cells) and cytotoxic/supprossor T-cells (CD8+
cells) in peripheral blood of normal and pathological conditions such as
immunodeficiency disorders. It is one component of the suggested monoclonal
antibody (MAb) combinations for routine immunophenotyping of lymphocytes in
peripheral blood using flow cytometry. | |
| Comparison of
Technological
Characteristics | Performance characteristics have been established by clinical evaluation of
compared to the individual single reagent predicate devices that quantitatively
measure CD4+ and CD8+ T-cells that have been previously cleared by FDA
(CytoStat/Coulter Clone T8-RD-1/T4-FITC). When flow cytometric tests of
peripheral blood samples obtained from apparently healthy adults were
completed, correlation of CytoStat/CoulterClone T8-RD-1/T4-FITC with DAKO
CD4/CD8 approached a direct 1 : 1 comparison for measurement of CD4 + | |
Nov. 27. :995
cells. Correlation of CytoSrat/CoulterClone T8-RD-1/T4-FITC with DAKO
1
CD4/CD8 approached a direct 1 : 1 comparison for measurement of CD8 + cells. Data for the measurement of CD4+ T-cells by DAKO CD4/CD8 reagent compared to CytoStat/CoulterClone T8-RD-1/T4-FITC on peripheral blood samples obtained from apparently healthy adults as well as ill patients gave a correlation greater than 0.98 us nq the whole blood method for flow cytomery. Data for the measurement of CD8+ T-cells by DAKO CD4/CD8 reagent compared to CytoStat/CoulterClone T8-RD-1/T4-FITC gave a correlation greater than 0.98 using the whole blooc method for flow cytometry.
The CD4 antibody clone, MT31(; was clustered at the Second Leukocyte Typing Workshop,Boston , 1984. The CD8 antibody clone, DK25, was clustered at the Third Leukocyte Typing Workshop,Oxford, England, 1986 under another clone designation.
Linearity testing of DAKO CD4/FITC using CEM cells gave the following linear equation:
v =4.26% + 0.93x; r = 0.999
Linearity testing of DAKO CD8/FIPE using JM cells gave the following linear equation:
y = 0.06% + 1.01x; r = 0.999
In addition, reproducibility of DAKO reagents using replicates (from peripheral blood) run on two different flow cytometers was measured at three concentrations of each antigen. Cross-reactivity of CD4/CD8 with peripheral blood cells (red blood cells, monocytes, granulocytes, lymphocytes, and platelets) was measured.
Conclusions:
Results of the above testing as well as the information provided by the Second and Third Leukocyte Typing Workshops indicate that the CD4/CD8 reagent V performs as well as CytoStat/CoulterClone T8-RD-1/T4-FITC in the detection and enumeration of CD4 and CD8 lymphocytes using flow cytometry. Safety of the DAKO CD4/CD8 reagent and its predicate device is high as are all reagents used for in vitro testing.