(75 days)
No
The summary describes a flow cytometry reagent for identifying T-cell subpopulations based on antibody binding and fluorescence, with no mention of AI or ML for data analysis or interpretation.
No
The device is described as an "In Vitro Diagnostic Use" for analyzing T-cells in peripheral blood for diagnostic purposes, not for treating any condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "For In Vitro Diagnostic Use" and mentions its purpose for "simultaneous detection and quantification of CD3CD4 cells (CD4 positive T-lymphocytes) in normal and pathological conditions such as immunodeficiency disorders," which are indicative of a diagnostic function.
No
The device description clearly states it is a reagent (purified mouse anti-human CD3 and CD4 conjugated with fluorochromes) used in flow cytometry, which is a physical substance and not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first line explicitly states "For In Vitro Diagnostic Use". It also describes the use of the device for analyzing CD3 and CD4 T-cells in peripheral blood for diagnostic purposes in normal and pathological conditions.
- Device Description: The description details a reagent (antibodies conjugated with fluorochromes) used to stain cells in a biological sample (peripheral blood) for analysis. This is characteristic of an IVD.
- Input Imaging Modality: Flow cytometry is a technique used to analyze cells in a fluid sample, which is consistent with in vitro analysis.
- Anatomical Site: Peripheral blood is a biological specimen collected from the body for in vitro testing.
- Performance Studies: The performance studies describe the evaluation of the device using peripheral blood samples and comparing it to predicate devices that also measure CD3 and CD4 T-cells, further supporting its use as a diagnostic tool.
- Predicate Device(s): The listed predicate devices are also IVDs used for similar purposes.
All these factors strongly indicate that this device is intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
For In Vitro Diagnostic Use Mouse Anti-Human T-cell, CD3/FITC, UCHT1 + - Mouse Anti-Human T-cell, CD4/RPE, MT310 (DAKO Anti-CD3/FITC and Anti-CD4/RPE) has been developed for use in flow cytometry for the analysis of CD3 and CD4* T-cells. This reagent allows simultaneous detection and quantification of CD3CD4 cells (CD4 positive T-lymphocytes) in 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 CD3, Clone UCHT1, conjugated with fluorescein isothiocyanate, isomer 1 (FITC) + purified mouse anti-human CD4, Clone MT310, conjugated with R-phycoerythrin, present in 0.05M Tris-HCl buffer, pH 7.2, 15 mM NaNo, 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison of Technological Performance characteristics have been established by clinical evaluation of DAKO Anti-CD3/FITC and Anti-CD4/RPE compared to the individual single reagent predicate devices that quantitatively measure CD3 and CD4* T-cells that have been previously cleared by FDA (DAKO CD3/FITC, Code No. F0818 and DAKO CD4/RPE, Code No. R0805). When flow cytometric tests of peripheral blood samples obtained from apparently healthy adults were completed, correlation of Anti-CD3/FITC, UCHT1 with DAKO Anti-CD3/FITC and Anti-CD4/RPE approached a direct 1 : 1 comparison for measurement of CD3 + cells. Correlation of Anti-CD4/RPE, MT310 with DAKO Anti-CD3/FITC and Anti-CD4/RPE approached a direct 1 : 1 comparison for measurement of CD4 + cells. Data for the measurement of CD3 + T-cells by DAKO Anti-CD3/FITC and Anti-CD4/RPE reagent compared to DAKO CD3/FITC gave a correlation greater than 0.96 using the whole blood method for flow cytometry. Data for the measurement of CD4+ T-cells by DAKO Anti-CD3/FITC and Anti-CD4/RPE reagent compared to DAKO CD4/RPE gave a correlation greater than 0.96 using the whole blood method for flow cytometry. Linearity testing of DAKO CD3/FITC using JM cells gave the following linear equation: y = 0.02 + 0.98x; r = 0.999 Linearity testing of DAKO CD4/RPE using CEM cells gave the following linear equation: y = - 0.01 + 1.03x; 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 Anti-CD3/FITC, plus Anti-CD4/RPE with peripheral blood cells (red blood cells, monocytes, granulocytes, lymphocytes, and platelets) was measured. Results of the above testing as well as the information provided by the First and Second Leukocyte Typing Workshops indicate that the DAKO Anti-CD3/FITC plus Anti-CD4/RPE reagent performs as well as DAKO CD3/FITC in the detection and enumeration of CD3 Iymphocytes while the DAKO Anti-CD3/FITC plus Anti-CD4/RPE reagent performs as well as DAKO CD4/RPE in the detection and enumeration of CD4* lymphocytes using flow cytometry.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
DAKO Monoclonal Mouse Anti-Human T-cell, CD3/FITC, UCHT1 (DAKO Code Number F0818, FDA K942797), DAKO Monoclonal Mouse Anti-Human helper/inducer T-cell, CD4/RPE, Clone MT310 (DAKO Code Number R0805, FDA K945212)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
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510lk | Summary Submitter: DAKO Corporation 6392 Via Real Carpinteria. CA 93013 (805)566-6655 Gretchen M. Murray, Ph.D., Regulatory Affairs Asst. Manager Contact: Date Summary December 27, 1995 Prepared: Mouse Anti-Human T-cell, CD3/FITC, UCHT1 + Device Name: Mouse Anti-Human T-cell, CD4/RPE, MT310 Device Class II according to 21 CFR 864.5220, on the basis that monoclonal antibodies Classification: are accessories for automated differential cell counters. This device classification is under the Hematology and Pathology devices panel, Panel: Division of Clinical Laboratory Devices. Product Code: GKZ DAKO Monoclonal Mouse Anti-Human T-cell, CD3/FITC, UCHT1 (DAKO Code Predicate Device(s): Number F0818, FDA K942797) and DAKO Monoclonal Mouse Anti-Human helper/inducer T-cell, CD4/RPE, Clone MT310 (DAKO Code Number R0805, FDA K945212) Purified mouse anti-human CD3, Clone UCHT1, conjugated with fluorescein Device Description: isothiocyanate, isomer 1 (FITC) + purified mouse anti-human CD4, Clone MT310, conjugated with R-phycoerythrin, present in 0.05M Tris-HCl buffer, pH 7.2, 15 mM NaNo, 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, CD3/FITC, UCHT1 + - Mouse Anti-Human T-cell, CD4/RPE, MT310 (DAKO Anti-CD3/FITC and Anti-CD4/RPE) has been developed for use in flow cytometry for the analysis of CD3 and CD4* T-cells. This reagent allows simultaneous detection and quantification of CD3CD4 cells (CD4 positive T-lymphocytes) in 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 Performance characteristics have been established by clinical evaluation of Characteristics DAKO Anti-CD3/FITC and Anti-CD4/RPE compared to the individual single reagent predicate devices that quantitatively measure CD3 and CD4* T-cells that have been previously cleared by FDA (DAKO CD3/FITC, Code No. F0818 and DAKO CD4/RPE, Code No. R0805). When flow cytometric tests of peripheral blood samples obtained from apparently healthy adults were
NOV. 27. 1905
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completed, correlation of Anti-CD3/FITC, UCHT1 with DAKO Anti-CD3/FITC and Anti-CD4/RPE approached a direct 1 : 1 comparison for measurement of CD3 + cells. Correlation of Anti-CD4/RPE, MT310 with DAKO Anti-CD3/FITC and Anti-CD4/RPE approached a direct 1 : 1 comparison for measurement of CD4 + cells. Data for the measurement of CD3 + T-cells by DAKO Anti-CD3/FITC and Anti-CD4/RPE reagent compared to DAKO CD3/FITC gave a correlation greater than 0.96 using the whole blood method for flow cytometry. Data for the measurement of CD4+ T-cells by DAKO Anti-CD3/FITC and Anti-CD4/RPE reagent compared to DAKO CD4/RPE gave a correlation greater than 0.96 using the whole blood method for flow cytometry.
The CD3 antibody clone, UCHT1, was clustered at the First Leukocyte Typing Workshop, Paris, France, 1982. The CD4 antibody clone, MT310, was clustered at the Second Leukocyte Typing Workshop, Boston, 1984.
Linearity testing of DAKO CD3/FITC using JM cells gave the following linear equation:
y = 0.02 + 0.98x; r == 0.999
Linearity testing of DAKO CD4/RPE using CEM cells gave the following linear equation:
y = - 0.01 + 1.03x; 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 Anti-CD3/FITC, plus Anti-CD4/RPE 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 First and Second Leukocyte Typing Workshops indicate that the DAKO Anti-CD3/FITC plus Anti-CD4/RPE reagent performs as well as DAKO CD3/FITC in the detection and enumeration of CD3 Iymphocytes while the DAKO Anti-CD3/FITC plus Anti-CD4/RPE reagent performs as well as DAKO CD4/RPE in the detection and enumeration of CD4* lymphocytes using flow cytometry. Safety of the DAKO Anti-CD3/FITC plus Anti-CD4/RPE reagent and its individual predicate devices is high as all reagents are used for in vitro testing.